Hominis Surgical System

DEN190022 · Momentis Surgical , Ltd. · QNM · Feb 26, 2021 · General, Plastic Surgery

Device Facts

• Record ID: DEN190022
• Device Name: Hominis Surgical System
• Applicant: Momentis Surgical , Ltd.
• Product Code: QNM · General, Plastic Surgery
• Decision Date: Feb 26, 2021
• Decision: DENG
• Submission Type: Direct
• Regulation: 21 CFR 878.4961
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Hominis Surgical System is an endoscopic instrument control system that is intended to assist in the accurate control of the Hominis Arms during single site, natural orifice laparoscopic-assisted transvaginal benign surgical procedures listed below. The Hominis Surgical System is indicated for use in adult patients. It is intended to be used by trained physicians in an operating room environment. The representative uses of the Hominis Surgical System are indicated for the following benign procedures: Total Benign Hysterectomy with Salpingo-Oophorectomy; Total Benign Hysterectomy with Salpingectomy; Total Benign Hysterectomy; Salpingectomy; Oophorectomy; Adnexectomy; Ovarian cyst removal.

Device Story

Hominis Surgical System is a software-controlled, electromechanical surgical system mounted to a patient bed or operating table. It features electromechanical arms that provide accurate control of endoscopic surgical instruments during single-site, natural orifice laparoscopic-assisted transvaginal procedures. Operated by trained physicians in an operating room, the system translates user inputs into precise instrument movements. The device assists in performing benign gynecological procedures, including hysterectomies and adnexectomies. By providing enhanced control and access through a natural orifice, the system aims to facilitate minimally invasive surgery, potentially reducing patient trauma associated with traditional laparoscopic approaches. Safety is managed through rigorous human factors validation, software verification, and mandatory specialized training programs for all users.

Clinical Evidence

Prospective, multi-center, single-arm study (N=30) evaluated safety and effectiveness for transvaginal hysterectomy. Primary endpoint: 0% conversion rate to open/manual laparoscopy (100% completion). Secondary endpoints: No intraoperative adverse events; 23% of subjects had delayed vaginal cuff healing (resolved 9-14.5 weeks); no reoperations, readmissions, or mortalities. Bench testing confirmed electromechanical motion accuracy, system latency, and thermal safety. Animal (ewe) and cadaver studies validated workflow and anatomical access.

Technological Characteristics

Mountable electromechanical system; 6 degrees of freedom per arm. Materials: biocompatible per ISO 10993. Energy: Monopolar/bipolar electrosurgery (via third-party generator). Connectivity: Wired (MU-CU cables). Sterilization: Ethylene Oxide (EO) for arms/gaskets (SAL 10^-6); reusable components via steam sterilization or low-level disinfection. Software: Major level of concern; 4 modules (Control Console, Motor Units, Power Logic, Joystick).

Indications for Use

Indicated for adult patients undergoing benign surgical procedures: Total Benign Hysterectomy with Salpingo-Oophorectomy, Total Benign Hysterectomy with Salpingectomy, Total Benign Hysterectomy, Salpingectomy, Oophorectomy, Adnexectomy, and Ovarian cyst removal.

Regulatory Classification

Identification

A mountable electromechanical surgical system for transluminal approaches is a software-controlled, patient bed- and/or operating table-mounted electromechanical surgical system with human/device interfaces that allows a qualified user to perform transluminal endoscopic or laparoscopic surgical procedures using surgical instruments attached to an electromechanical arm.

Special Controls

*Classification.* Class II (special controls). The special controls for this device are:(1) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error. (2) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program. (3) The device manufacturer must conduct and complete post-market surveillance, including an impact of the training program on user learning, behavior, and performance, in accordance with an FDA-agreed-upon protocol. The device manufacturer must submit post-market surveillance reports that contain current data and findings in accordance with the FDA-agreed-upon protocol. (4) The device manufacturer must submit a report to FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information: (i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and (ii) Identification and rationale for changes made to the device, labeling or device-specific use training program, which did not require submission of a premarket notification during the reporting period. (5) Labeling must include: (i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified; (ii) A statement in the labeling that the safety and effectiveness of the device has not been evaluated for outcomes related to the treatment or prevention of cancer, including but not limited to risk reduction, overall survival, disease-free survival and local recurrence, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA; (iii) Identification of compatible devices; (iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification; (v) Reprocessing instructions for reusable components; (vi) A shelf life for any sterile components; (vii) A description of the device-specific use training program; (viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and (ix) A detailed summary of the post-market surveillance data collected under paragraph (b)(3) of this section and any necessary modifications to the labeling to accurately reflect outcomes based upon the post-market surveillance data collected under paragraph (b)(3) of this section. (6) Clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. (7) Human factors validation testing must be performed and must demonstrate that the user interfaces of the system support safe use in an operating room environment. (8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include: (i) Device motion accuracy and precision; (ii) System testing; (iii) Instrument reliability; (iv) Thermal effects on tissue; (v) Human-device interface; (vi) Mounting hardware testing; (vii) Workspace access testing; and (viii) Performance testing with compatible devices. (9) Software verification, validation, and hazard analysis must be performed. Software documentation must include an assessment of the impact of threats and vulnerabilities on device functionality and end users/patients as part of cybersecurity review. (10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed. (11) Performance data must demonstrate the sterility of all patient-contacting device components. (12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life. (13) Performance data must validate the reprocessing instructions for the reusable components of the device. (14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible. (15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic.

Submission Summary (Full Text)

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## DE NOVO CLASSIFICATION REQUEST FOR HOMINIS SURGICAL SYSTEM

### REGULATORY INFORMATION

FDA identifies this generic type of device as:

Mountable electromechanical surgical system for transluminal approaches. A mountable electromechanical surgical system for transluminal approaches is a softwarecontrolled, patient bed- and/or operating table-mounted electromechanical surgical system with human/device interfaces that allows a qualified user to perform transluminal endoscopic or laparoscopic surgical procedures using surgical instruments attached to an electromechanical arm.

NEW REGULATION NUMBER: 21 CFR 878.4961

CLASSIFICATION: Class II

PRODUCT CODE: QNM

## BACKGROUND

DEVICE NAME: Hominis Surgical System

SUBMISSION NUMBER: DEN190022

DATE OF DE NOVO: April 17, 2019

CONTACT: Memic Innovative Surgery Ltd. 6 Yonatan Netanyahu. Or Yehuda 6037604, Israel

#### INDICATIONS FOR USE

The Hominis Surgical System is an endoscopic instrument control system that is intended to assist in the accurate control of the Hominis Arms during single site, natural orifice laparoscopic-assisted transvaginal benign surgical procedures listed below. The Hominis Surgical System is indicated for use in adult patients. It is intended to be used by trained physicians in an operating room environment.

The representative uses of the Hominis Surgical System are indicated for the following benign procedures:

- Total Benign Hysterectomy with Salpingo-Oophorectomy ●
- Total Benign Hysterectomy with Salpingectomy ●
- Total Benign Hysterectomy ●

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- Salpingectomy
- Oophorectomy
- Adnexectomy
- Ovarian cyst removal ●

# LIMITATIONS

The sale, distribution, and use of the Hominis Surgical System is restricted to prescription use in accordance with 21 CFR 801.109.

The Hominis Surgical System may only be distributed to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program.

PLEASE REFER TO THE LABELING FOR A MORE COMPLETE LIST OF CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS.

# DEVICE DESCRIPTION

The Hominis Surgical System (see Figure 1) is a mountable electromechanical surgical system for transluminal approaches used in single-site benign hysterectomy and salpingo-oophorectomy surgical procedures through a transvaginal access point. The system consists of two (2) Hominis Arms, a Hominis Control Console, a Hominis Motor Units Assembly, and Hominis Surgical System Accessories (Hominis Sterile Drape, GYN Trocar Kit, Hominis System Cables, and Bed Fixation Kit). During clinical use, surgeons operate the Hominis Arms from the Hominis Control Console with a compatible and FDA-cleared third-party standard laparoscope (transumbilical) and visual guidance system.

Image /page/1/Picture/10 description: The image shows a robotic surgical system labeled with different components. The system includes an adjustable seat, joystick 1, thumbstick 1, and a touchscreen on the left side. On the right side, there is a motor units assembly, arms, a bed fixation kit, and MU-CU cables.

Figure 1: Hominis Surgical System

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A description of each component is provided below:

# Hominis Control Console

The Hominis Control Console is the main human-device interface, which includes an adjustable chair where the surgeon is seated and controls each Hominis Arm through the two (2) Motor Units. The Hominis Control Console contains the following key components: two (2) sets of arm controllers (joysticks and thumbsticks), an adjustable joystick stand, touchscreen with a graphics user interface (GUI), Manual Release Tool, power adapter, emergency-off button. The functions of the Hominis Control Console include:

- Providing guidance to the user for initialization of the Hominis Surgical System, both ● during procedure initiation and upon resumption from a paused state.
- . Displaying status of the Hominis Surgical System components (e.g., connectivity of components, pause/resume status of the Hominis Arms, electrosurgical energy associations with the Hominis Arms, etc.).
- . Controling and manipulating the Hominis Arms during the procedure using the two sets of arm controllers and buttons.
- . Enabling the surgeon to adjust the position and orientation of the joysticks according to the surgeon's needs.
- . Supplying power to the Hominis Surgical System by connecting the Hominis Control Console to the main supply.
- . Containing buttons for powering the device (i.e. on/off) and emergency stop of the system.
- . Housing the Manual Release Tool which is used during emergency extraction of the system to manually straighten the Hominis Arms.

# Hominis Arm (Joystick) Controller

There are two (2) sets of arm controllers for the Hominis Surgical System: the two (2) thumbsticks and two (2) joysticks. The first set of arm controllers is the pair of thumbsticks (one thumbstick for each Hominis Arm) located at the sides of the screen. These thumbsticks are used at the beginning of each procedure in order to reach a baseline retroflexion, and for insertion and extraction of the arms. Similarly, a pair of joysticks (one joystick for each Hominis Arm) allows for the accurate control of the Hominis Arms with all the degrees of freedom for manipulating the tissue at the surgical site.

## Hominis Arms

The Hominis Arms are sterile, single-use components that are inserted transvaginally to perform the indicated surgical procedures. Two identical Hominis Arms are connected to a Motor Unit, each of which corresponds to the respective hand of the surgeon as controlled by right or left thumbstick and joystick. The Hominis Arms include a rigid section (shaft), a flexible section (articulated section containing joints), and a handle. The end effector, located at the distal end of the flexible section, enables tissue grasping and displacement, and electrosurgical application of monopolar and bipolar energy.

# End Effectors

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The end effector is comprised of the spatula that can apply monopolar electrosurgical energy and a fenestrated grasper that can apply bipolar electrosurgical energy as well as grasp and manipulate the tissue. This is determined by connecting the corresponding Motor Unit to the generator with the appropriate electrosurgical cable and operating the generator's foot pedals. The end effectors are not intended for vessel sealing.

# Hominis Motor Units Assembly

The Hominis Motor Units Assembly contain three (3) main components: A) an interface for insertion of the Hominis Arms, B) locking doors which secure the Hominis Arms once inserted, and C) a cable panel. There are two (2) Motor Units (MUs) within the housing unit and each MU drives one Hominis Arm independently with six (6) degrees of motion. The two MUs are similar in function and purpose with the right MU including an adaptor that enables mounting of the Hominis Motor Unit Assembly to the Bed Fixation Kit and a mechanism that controls the linear movement of the MUs and Hominis Arms. The Hominis Motor Units Assembly is also connected to the electrosurgical generator. Two (2) Hominis Sterile Drapes are provided to separate the MUs from the sterile field, to maintain sterility. Two (2) Hominis System Cables (or MU-CU cables) are supplied to connect the MUs to the to the Hominis Control Console.

# Hominis Surgical System Accessories

Hominis Surgical System accessories listed below are provided with each Hominis Surgical System.

GYN Trocar Kit: The GYN Trocar Kit is comprised of several accessories that help to facilitate insertion of the Hominis Arms transvaginally. The GYN Trocar Kit contains a sterile trocar, short/long cannula, protective sheath, sheath gasket, blunt dilator, trocar introducer, and GYN Fixation Arm with GYN Guiding Rail. The GYN Trocar Kit allows for safe entry into the pelvic cavity through the Pouch of Douglas. Additionally, it maintains the pneumoperitoneum (via cannula and sheath gaskets) while guiding the Hominis Arms through the peritoneum.

Non-Sterile Bed Fixation Kit: The MUs are affixed firmly to the surgical bed via the Bed Fixation Kit, which includes a Surgical Fixation Arm and an extension rail. The Surgical Fixation Arm is attached to the MUs through the Motor Units Adaptor. The Hominis Arm can be attached to the surgical table directly or through the extension rail.

# Third-party Devices

The Hominis Surgical System is intended to be used with the following third-party devices (these are not provided with the Hominis Surgical System) to enable the subject device to perform its intended purpose. Compatible third-party devices are listed in Table 1.

| Components | Description | 510(k) # | Sterile | Disposable |
|-----------------------------------------|---------------------------------------------------------------------------------|----------|---------|------------|
| Electrosurgical<br>Generator | Valleylab FT10TM, electrosurgical<br>generator manufactured by Covidien | K191601 | No | No |
| Applied Medical<br>GelPoint Mini Access | Surgical access port utilized with the<br>GYN Trocar Kit to enable transvaginal | K191866 | Yes | Yes |

## Table 1: Third-Party Devices Not Provided with the Hominis Surgical System

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| Platform | | | | |
|-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|---------------------|------------------------------|
| | insertion of the Hominis Arms into the<br>abdominal cavity. | | | |
| Auxiliary Port | A single port to be inserted<br>transabdominally to support insertion of<br>an off-the-shelf visualization system<br>together with any additional off the shelf<br>surgical instruments. | FDA-cleared<br>devices | Yes | Reusable<br>or<br>disposable |
| Monopolar and Bipolar<br>Electrosurgical Cables | Connects the Electrosurgical Generator<br>to the Hominis Surgical System. | Monopolar<br>(K143662)<br>Bipolar (K981919) | No | No |
| Compatible Devices | Laparoscopic Camera and Visualization System (a k.a<br>Tower and Scope). The Hominis Surgical System is<br>used with a standard Operating Room visualization<br>system, including monitors and an endoscope to enable<br>visualization of the surgical site. | FDA-cleared<br>devices | Device<br>dependent | Device<br>dependent |
| | The Hominis Surgical System can be used in<br>conjunction with the following off-the-shelf manual<br>laparoscopic instruments through the abdominal<br>incision port, in accordance with the device's Intended<br>Use:<br>• Vessel Sealers<br>• Scissors<br>• Suction/Irrigator<br>• Graspers | FDA-cleared<br>devices | Device<br>dependent | Device<br>dependent |

# SUMMARY OF NON-CLINICAL/BENCH STUDIES

Non-clinical performance tests were performed to demonstrate that the Hominis Surgical System will perform as anticipated for its intended use and to mitigate the risks to health as outlined below.

## BIOCOMPATIBILITY/MATERIALS

The purpose of testing all materials for biocompatibility and pyrogenicity is to mitigate the risk of adverse tissue reactions and infections for the patient.

All components are external communicating devices in contact with tissue/bone/dentin for limited duration (<60 (4/10/10/19). Therefore, the following tests - cytotoxicity, sensitization, irritation/intracutan us reactivity, acute systemic toxicity, material-mediated pyrogenicity, and hemolysis – were performed according to applicable standards and guidance.

- . ISO 10993-1 Fifth edition 2018-08 - Biological evaluation of medical devices -- Part 1 : Evaluation and testing within a risk management process.
- . ISO 10993-5: 2009/ revised 2014, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity.
- ISO 10993-10: 2010/ revised 2014, Biological evaluation of medical devices Part 10: . Tests for irritation and skin sensitization.

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- . ISO 10993-12: 2012, Biological evaluation of medical devices – Part 12: Sample preparation and reference materials.
- . ISO 10993-4: 2017 Biological evaluation of medical devices – Part 4: Selection of tests for interaction with blood.
- . ISO 10993-11: 2017 Biological evaluation of medical device – Part 11: Tests for systemic toxicity.
- . ASTM F756: 2017 Standard Practice for Assessment of Hemolytic Properties of Materials
- United States Pharmacopeia 42, National Formulary 37, 2019. <151> Pyrogen Test. .
- . FDA Guidance: Use of International Standard ISO 10993-1: 2016, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" -Guidance for Industry and Food and Drug Administration Staff.

All testing and results were considered to be adequate and met the above standards.

# STERILITY/REPROCESSING/PACKAGING/SHELF LIFE

The purpose of the sterility, reprocessing, packaging, and shelf life evaluations were to mitigate the risk of infection for the patient.

Each Hominis Arm is packaged with the Cannula Gasket and Sheath Gasket and provided in sterile condition. The arm and gaskets are packaged in a blister, pouched, and then boxed individually prior to sterilization. The boxed arm and gaskets are placed in shipping box and sterilized using Ethylene Oxide (EO) to a sterility assurance level (SAL) of 106. Other device components are provided non-sterile for reuse. The Hominis Arm package was shelf-life tested using ""year accelerated aging in accordance with American Society of Testing and Materials (ASTM) F1980 - Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices. In addition to testing the packaging integrity, functionality testing was performed for each of the components contained in the package. All test samples were sterilized (b) (4) prior to accelerated aging.

The Hominis Surgical System's reusable components are the Hominis Control Console, Hominis Motor Units Assembly, Bed Fixation Kit, and GYN Trocar Kit. The GYN Trocar Kit is a stainless-steel component that must be inspected before each use according to its reprocessing instructions and may be used unless any damage or failure is present. The life expectancy of the Bed Fixation Kit is two years. The GYN Trocar Kit must be cleaned and sterilized prior to reuse. Other reusable system parts require only low-level disinfection.

Reprocessing for reusable components was validated in accordance with Association for the Advancement of Medical Instrumentation (AAMI) TIR30, AAMI TIR12, the FDA guidance document titled, "Reprocessing Medical Devices in Health Care Settings: ValidationMethods and Labeling - Guidance for Industry and Food and Drug Administration Staff" (March 17, 2015), and ISO 17665-1. The GYN Trocar Kit reprocessing involves the following steps:

- 1. Disassembly and pre-cleaning
- 2. Manual cleaning
- 3. Rinsing after manual cleaning

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- 4. Steam sterilization
- 5. Inspection prior to use

All testing and results were considered to be adequate and met the above standards.

## ELECTROMAGNETIC COMPATIBILITY AND ELECTRICAL SAFETY

The EMC and Electrical Safety was evaluated to mitigate the risk of electrical fault resulting in injury to patient or user.

The following Electrical/ Mechanical/Thermal Safety, and electromagnetic compatibility (EMC) testing has been performed:

- IEC 60601-1: 2012 reprint, Medical electrical equipment Part 1: General requirements . for basic safety and essential performance
- . IEC 60601-2-2: 2017, Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequencv surgical accessories
- . IEC 60601-1-2: 2014, General requirements for basic safety and essential performance -Collateral Standard: Electromagnetic disturbances - Requirements and tests

All testing and results were considered to be adequate and met the above standards.

## WIRELESS TECHNOLOGY

The Hominis Surgical System does not incorporate wireless technology.

#### SOFTWARE

The software was evaluated to mitigate the risks of thermal, electrical, and mechanical faults associated with device not working as intended due to the programming, and tissue perforation and/or injury due to system malfunctions.

The Hominis Surgical System Software consists four (4) separate modules - the Hominis Control Console software, the Hominis Motor Units Module software, the Power Logic Board software, and the Joystick Module software. The Hominis Control Console software presents the main user interface for the Hominis Surgical System and runs on the touchscreen computer of the Hominis Control Console. The remainder of the software modules control the functions of their respective hardware. The complete software is responsible for the following functions:

- Monitoring the Joysticks' movements. •
- . Driving the MUs (Motor Units) according to the Joysticks' movements.
- . Displaying relevant information to the user.
- . Enabling the user to configure certain aspects of the system through a graphical user interface.

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The Hominis Surgical System software was developed in accordance with the following FDA guidance documents and standards:

- 1) FDA guidance document titled, General Principles of Software Validation, issued January 11, 2002
- 2) FDA guidance document titled, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, issued May 11, 2005
- 3) FDA guidance document titled, Off-the-Shelf Software Use in Medical Devices, issued September 27, 2019
- 4) IEC 62304, Medical Device Software Software Life-Cycle Processes
- 5) ISO 14971, Medical devices Application of Risk Management to Medical Devices

CDRH considers the software to be a major level of concern (LOC) because failure or latent flaw could directly result in death or serious injury to the patient or operator. Furthermore, a failure or latent flaw could indirectly result in death or serious injury of the patient or operator through incorrect or delayed information or through the action of a healthcare provider.

The submission contained all the elements of software documentation corresponding to a "major" level of concern, as outlined in the FDA guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." This includes documentation describing the software, firmware, software specifications, architecture design, software development environment, traceability, revision level history, unresolved anomalies and cvbersecurity. The documentation provides sufficient information to conclude that the software will operate in a manner as described in the specifications. A hazard analysis was performed to characterize software risks including device malfunction and measurement related errors.

Overall, the software documentation contains sufficient detail to provide reasonable assurance that the software will operate in a manner described in the specifications. All testing and results were considered to be adequate and met the above standards.

# CYBERSECURITY

Cybersecurity was evaluated to mitigate tissue perforation and/or injury due to system malfunction.

The Hominis Surgical System was evaluated for cybersecurity risks consistent with the FDA guidance document titled, Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, issued October 2, 2014.

The submission contained information about software malfunctions, malicious or otherwise, which could lead to patient harm, or the abilty to control/manipulate/affect the device remotely, whether by design or not. Software security information was provided demonstrating the device is protected from cyber vulnerability threats originating either via a local port or the network.

# NON-CLINICAL PERFORMANCE TESTING - BENCH

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The following bench tests were performed to mitigate the risks of thermal, electrical, and mechanical fault resulting in injury to patient or user, tissue perforation and/or injury due to system malfunction, user error resulting in patient injury

The bench tests characterize device performance and design verification for the Hominis Surgical System. All applicable testing was performed with provided and third-party devices. The descriptions and results of the bench tests are summarized in Table 2.

| Test Description | Objective | Acceptance Criteria | Results |
|----------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Electromechanical arm<br>motion accuracy | Demonstrate that the Hominis Arm<br>is able to reach the entire intended<br>workspace based on pre-defined<br>acceptance criteria. | Elbow and wrist can be fully rotated<br>360°<br>Elbow flexion angle is 210° (b) (4)<br>Shoulder flexion angle is 175° (b) (4)<br>Shoulder can be rotated clockwise<br>and counter clockwise no less than<br>(b) (4)<br>Gripper jaw range (b) (4) | Pass |
| Instrument Motion<br>Accuracy | Demonstrate the accuracy of the<br>surgical instruments and quantify the<br>amount of unintended motion when<br>under surgeon control. | Hominis Arm end-effector<br>successfully pulls the ring through<br>the wire without contact between<br>both, at vertical, and horizontal<br>orientation of the wire | Pass |
| System latency | Determine system latency of each<br>tested degree of freedom to ensure<br>that it is within the pre-defined<br>acceptable range. | Minimal calculated system latency<br>of each tested degree of freedom is<br>no greater than (b) (4) | Pass |
| Droop Rate | Demonstrate under single fault<br>conditions that the end-effector of<br>the Hominis Arm does not droop or<br>apply force under gravity based on<br>the pre-defined acceptance criteria. | Maximal movement of the motor<br>unit and Hominis Arm after power<br>cut-off shall be (b) (4) | Pass |
| System components<br>integrity, loading and<br>mechanical properties | Demonstrate the component's<br>rigidity, yield strength, ability to<br>withstand anticipated loads, tensile<br>forces and torque application (e.g.,<br>that the Hominis Arm can withstand<br>application of anticipated forces,<br>that Bed Fixation Kit and sustain the<br>load of the Motor Units Assembly<br>with Arms assembled, etc.) and<br>evaluate the lift and pull force of<br>the Arm. | Arm vertical deflection (b) (4)<br>Lift force: lift load of (b) (4)<br>Pull force: sustain load of (b) (4)<br>Actuation Cable: withstand max<br>load (b) (4)<br>Elbow Spring: withstand torque<br>condition of (b) (4)<br>Wrist Spring: withstand torque<br>condition of (b) (4)<br>Torque Cable: withstand torque<br>condition of (b) (4) | Pass |
| | | Elbow Joint: sustain bending<br>moment of (b) (4)<br>Shoulder Joint: sustain bending<br>moment of (b) (4) | |
| Electrosurgical<br>compatibility | Active electrode (monopolar and<br>bipolar) performance testing | Supports monopolar/bipolar energy<br>delivery (b) (4) efficiency | Pass |
| Thermal effects on<br>tissue | Evaluate the thermal effects on<br>tissue caused by the electrosurgical<br>functionalities (monopolar<br>cutting/coagulation and bipolar<br>coagulation) of the Hominis Arms | Histopathologic criteria:<br>Monopolar Cutting<br>- Extent of necrosis (at site or<br>adjacent) is minimal or absent<br>- Extent of edema is minimal or<br>absent<br>- Regular margins present at site<br>Monopolar Coagulation<br>- Extent of Necrosis (at site or<br>adjacent) is moderate or less<br>- Extent of edema is moderate or<br>less<br>- Regular Margins<br>Bipolar Coagulation<br>- Extent of Necrosis (at site or<br>adjacent) is moderate or less<br>- Extent of edema is moderate or<br>less<br>- Regular Margins | Pass |
| Arm simulated use<br>testing | Demonstrate that the Hominis Arms<br>maintain functionality for a full,<br>worst-case surgical procedure. | Life Expectancy and Usage:<br>Maintained full functionality and no<br>visual damage after performing full<br>simulated-use cycle of a<br>hysterectomy procedure<br>Insulation Sleeve Strength:<br>Insulation sleeve is intact with no<br>holes, tear, or other forms of<br>damage.<br>Insulation Sleeve Position:<br>insulation sleeve is securely at the<br>distal end after simulated-use cycle<br>Bipolar Wire:<br>- Bipolar wire is secured and<br>maintains integrity after use of | Pass |
| | | | |
| | | - arms and full range of joint<br>flexion<br>- Bipolar wire is securied and<br>maintains integrity at full range<br>of motion of the gripper jaws<br>- Bipolar wire is secured and<br>maintains ingegrity after being<br>articulated via wire protective<br>sleeve. | |
| | | Gripper Screw: screw withstood<br>maximal applied forces during usage | |
| System interfaces | Demonstrate that the system's<br>components, when used together,<br>are compatible and operate as<br>expected. | Gear Interface: no noises here when<br>Hominis Arms moved at all (b) (4)<br>Handle Interface: Arm successfully | Pass |
| Electrical properties | Verify system grounding, insulation,<br>ingress protection, power controls. | Jaw Insulation:<br>- No DC current electrical<br>conductivity on Gripper Jaws<br>backsides<br>- No AC Current electrical<br>conductivity on test specimen<br>Impedence of Arm (b) (4) | Pass |
| GYN Trocar Kit bench<br>testing | Demonstrate functional performance<br>of the GYN Kit with respect to the<br>vaginal access procedure, including<br>assembly of the GYN Trocar Kit,<br>compatibility with other components<br>of the Hominis System, structural<br>support for the Hominis Arms<br>during transvaginal access, as wellas the ability to maintain<br>pneumoperitoneum. | Arm-Gyn Interface:<br>- no damage occurred to the<br>silicone sleeve or GYN<br>protective sheath during<br>insertion and extraction<br>- insertion and extraction force no<br>more than (b) (4)<br>- torque during rotation of<br>shoulder tube through GYN<br>protective sheath no more than<br>(b) (4)<br>- Insulation sleeve remained<br>fixed and undamaged during<br>insertion | Pass |
| Bed Fixation<br>Kit bench<br>testing | Assess the physical and mechanical<br>properties of the Bed Fixation Kit<br>functional abilities with respect to<br>mounting and securing the Motor<br>Units onto the surgical bed and<br>compatibility with interfacing<br>components such as the Hominis<br>Arms and sterile drape. | Load Bearing: Able to hold weight<br>of fully extended arm with 8kg<br>weight<br>Table Mounting: Bed Fixation Kit<br>adapter able to hold (b) (4) weight<br>without damage | Pass |

Table 2: Bench Test Summary

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# ANIMAL AND CADAVER PERFORMANCE TESTING

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Performance testing was completed using animals and cadaver models to show that surgical procedures could be performed with the Hominis Surgical System and the associated 30 party components and accessories as a system.1

A summary of the evaluation and results from these studies can be found in Table 3.

| Test | Purpose | Method | Results |
|---------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| GLP Ewe Study | The purpose of the<br>animal studies were to<br>evaluate the performance<br>of the Hominis Surgical<br>System in performing<br>surgical tasks of<br>laparoscopic<br>transvaginal<br>gynecological<br>procedures in a live<br>model. | Design: Hysterectomy<br>with bi-lateral salpingo-<br>oophorectomy) was<br>performed transvaginally<br>on five ewe models for a<br>total of five surgical<br>procedures utilizing the<br>Hominis Surgical System.<br>Ewe gynecological model<br>was chosen for this study<br>as it simulates the female<br>reproductive organs, the<br>clinical setting,<br>anatomical environment<br>risks, and transvaginal<br>access.<br>The studies included<br>evaluations of procedure<br>completion, surgical task<br>performance, thermal<br>spread, system<br>performance, safety, and<br>short-term outcomes and<br>complications.<br>Endpoints:<br>Likert Scale (1-5) and<br>Questionnaire<br>- Performance and<br>Surgical Tasks<br>- Device Performance<br>- Procedural<br>Completion<br>- Homostasis:<br>Monopolar and<br>Biopolar Coagulation | All procedures were<br>successfully<br>completed, including<br>safely and successfully<br>performing<br>transvaginal access<br>with the GYN Trocar<br>Kit. No device-related<br>complications or<br>adverse events<br>occurred, and the<br>system performance<br>successfully (b)(4)<br>score<br>for the following<br>evaluations<br>- Performance and<br>Surgical Tasks<br>- Device<br>Performance<br>- Procedural<br>Completion<br>- Homostasis:<br>Monopolar and<br>Biopolar<br>Coagulation<br>- System Safety<br>Evaluation |
| Test | Purpose | Method | Results |
| | | - System Safety Evaluation | |
| Cadaver Study | - Evaluating performance for anatomical access and reach<br>- Evaluating performance for surgical task as part of workflow<br>- Validating ability to complete intended surgical procedures in cadaver model<br>- Validating performance working in human anatomy | Design: The cadaver study was performed by two surgeons on a total of five (5) female cadavers. The study consisted of performing transvaginal laparoscopic surgical hysterectomy with bi- lateral salpingo- oophorectomy.<br>Each cadaver procedure had the following surgical steps performed to evaluate the entire workflow: cadaver positioning, system configuration, draping, system self-test, vaginal access, Hominis Arms (insertion, surgical procedures, and extraction), system disconnection, and specimen removal and vaginal cuff suturing.<br>Endpoints: Likert Scale and Questionnaire<br>- Performance and Surgical Tasks<br>- Device Performance<br>- Procedural Completion<br>- Homostasis: Monopolar and Biopolar Coagulation<br>- System Safety Evaluation | All procedures were successfully completed, including safely and successfully performing transvaginal access with the GYN Trocar Kit. No device-related complications or adverse events occurred, and the system performance successfully (b) (4) score for the following evaluations<br>- Performance and Surgical Tasks<br>- Device Performance<br>- Procedural Completion |

Table 3: Animal and Cadaver Performance Test Overview

FDA supports the principles of the "3Rs," to reduce, refine, and replace animal use in testing when feasible. We encourage submitters to consult with us if they wish to use a non-animal testing method which they believe is suitable, adequate, qualified for use with medical devices, and feasible. We will consider if such an alternative method could be assessed for equivalency to an animal test method.

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Results of the animal and cadaver study support that the Hominis Surgical System is capable of performing and completing specific surgical tasks as part of the indicated procedures workflow, minimizes thermal/electrical/mechanical damage at the intended anatomical sites, validates appropriate anatomical working space for trained users, and assures safe operation in addition to clinical performance testing.

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# HUMAN FACTORS

Human Factors Testing was performed to mitigate the risks of electrical, mechanical, and thermal faults or device-specific use error that result in injury to the patient or user. Usability testing was performed in accordance with FDA guidance document titled, Applying Human Factors and Usability Engineering to Medical Devices, issued February 3, 2016, to demonstrate the device usability.

# Purpose

The usability validation study was conducted to evaluate whether the Hominis Surgical System, as designed, supports safe use by representative users when performing laparoscopic-assisted transvaginal gynecologic surgical procedures. The manufacturer-stated validation testing's purpose consisted of the following objectives:

- 1. Evaluate whether typical users can safely and effectively interact with the device;
- 2. Confirm that use-related risks have been appropriately captured and assessed in the UFMEA (Use Failure Mode Effects Analysis); or uncovering any previously unforeseen use errors.
- 3. Assess the effectiveness of the risk mitigation measures that have been applied during the Hominis Surgical System's design stage: and
- 4. Identify and validate the critical tasks and sub-tasks that were a part of the device use training program provided in the field.

Objective data and subjective feedback on the Hominis Surgical System's ease-of-use was also collected to inform future continuous usability improvement.

## Study Design

A total of 71 users, of which there were 24 US surgeons and 16 US Operating Room (OR) staff, participated in the study, and performed critical tasks as teams, as applicable, in accordance with the clinical use scenario. Surgeon participants exhibited a wide range of clinical experience (0 -40 years) and robotic surgical experience (0 - 10 years). A summary of the critical tasks and respective user roles can be found in Table 4. A summary of surgeon background experience separated by laparoscopic, vaginal, and robotic of the surgeons can be found in Table 5. US OR staff also varied in clinical experience (1 - 23 years), and robotic experience (0 - 10 years). A summary of all participants separated by region can be found in Table 6.

## Table 4: Critical Tasks

| Critical Task Procedure Step | Critical Tasks | User Roles |
|----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|------------------------------|
| OR Setup | Configure System | Non-sterile OR staff |
| OR Setup | Motor Units Installation | Non-sterile OR staff |
| Electrosurgery connections (these<br>two critical tasks were performed<br>together as a team) | Choose energy type | Non-sterile surgeon |
| | Connect electrosurgery cables | Sterile surgeon/OR staff |
| Arms mounting and draping (these<br>three (3) critical tasks were<br>performed together as a team) | Remove Hominis Arm from the<br>blister (by holding the rigid<br>portion) | Sterile OR Staff |
| | Mount the Hominis Arm | Non-sterile OR Staff |
| | Drape the System | Sterile OR staff |
| System Test | System self-test | Non-sterile surgeon |
| Joystick Test | Joystick test | Non-sterile surgeon |
| Vaginal Access | Vaginal access with the GYN Kit | Sterile surgeon |
| Docking (these two critical<br>tasks were performed<br>together as a team) | Dock System transvaginally | Sterile surgeon |
| | Bed Fixation Kit locking<br>- MU Fixation<br>- Arm locking | Non-sterile surgeon/OR staff |
| Surgical Steps | Retroflexion with use of<br>navigation joysticks. | Non-sterile surgeon |
| Surgical Steps | Manipulate instruments in<br>retroflexion using the joysticks | Non-sterile surgeon |
| Surgical Steps | Connect/disconnect electrosurgery<br>cables | Sterile surgeon |
| Surgical Steps | Pause/Resume control of<br>instruments | Non-sterile surgeon/OR staff |
| Surgical Steps | Operate Arms to null configuration<br>with use of navigation joysticks. | Non-sterile surgeon |
| Withdraw System | Withdraw Hominis Arms from<br>surgical site | Sterile surgeon |
| | | Non-sterile surgeon/OR staff |
| Relocate Surgical Fixation Arm<br>away from patient | Relocate Bed Fixation Kit away<br>from patient<br>- Relocating Surgical Fixation<br>Arm | Sterile surgeon |
| | | Non-sterile surgeon/OR staff |
| Exchange Tool | Replacing an Arm | Non-sterile surgeon |
| | | Sterile surgeon/OR staff |
| EMO Press and manual<br>release | Manual Release Tool usage<br>Emergency-off button usage | Non-sterile surgeon |

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# Table 5: Surgeon Years-of-Experience Type

| Experience<br>Type | Range<br>[Years] | Median<br>[Years] | Number of Surgeons<br>with no Experience | Number of Surgeons with less<br>than five (5) years of Experience |
|--------------------|------------------|-------------------|------------------------------------------|-------------------------------------------------------------------|
| Robotic | 0-10 | (b) (4) | | |
| Vaginal | 0-36 | | | |

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| Procedures | | | |
|--------------|------|--------|--|
| Laparoscopic | 0-40 | (b)(4) | |

| | No. of U.S.<br>Participants | Previous<br>Experience<br>with the<br>Hominis<br>Surgical<br>System [#<br>participants] | Previous<br>Experience<br>with Other<br>Robotic<br>Systems [#<br>participants] | Average<br>Experience<br>(including<br>residency and<br>fellowship)<br>[years] | Experience<br>(including<br>residency and<br>fellowship)<br>[min-max<br>years] | |
|----------|-----------------------------|-----------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|--------------------------------------------------------------------------------|--------------------------------------------------------------------------------|--|
| | | | U.S. Participants | | | |
| Surgeons | 24 | (b) (4) | | | 1-40 | |
| OR Staff | 16 | | | | 1-23 | |
| | | All Participants (U.S. and Non-U.S.) | | | | |
| Surgeons | 50 | (b) (4) | | | 1-40 | |
| OR Staff | 21 | | | | (b) (4) | |

## Table 6: Participant Background Experience

The usability of the Hominis Surgical System was evaluated according to a transvaginal approach and use workflow. The study was conducted in a simulated OR and involved preoperative preparation and simulated surgical procedures, as well as emergency procedures that involved safety critical tasks.

Critical tasks are user tasks which, if performed incorrectly or not performed at all, could cause serious harm to the patient or user. Harm is defined to also include compromised medical care. The tasks related to each risk were given a severity assessment ("") based on the UFMEA. The list of critical tasks was identified based on the potential harm associated with use-related issues (identified during the risk analysis process) that could arise from users inadvertently performing tasks incorrectly or failing to perform the necessary tasks.

Participants underwent a condensed training program with an emphasis on performing the critical tasks and sterile techniques within the surgical field. Condensed training considered worst-case scenario and training-decay was evaluated as part of use-related risk.

## Evaluation

For each critical task, the expected and incorrect responses were pre-defined based on sub-tasks and risks associated with that critical task, respectively. Task success criteria looked at expected and incorrect responses, and completion of the task safely and effectively, is outlined in Table 7.

| | Rating | Description |
|---|------------|---------------------------------------------------------------------------------------------------------------------------|
| 1 | Successful | User completed the task safely and effectively. |
| 2 | Difficult | User completed the task safely and effectively but had significant<br>hesitation or challenges while completing the task. |

## Table 7: Task Success Criteria for Each Critical Task

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| 3 | Close Call | User completed the task safely and effectively but performed it in a way<br>that presented a potential for patient harm (i.e., near-miss). |
|---|-----------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| 4 | Unsuccessful | User was unable to complete the task or did not complete the task safely<br>and effectively. |
| 5 | Did not perform | User did not perform the task, but due to reasons not related to the<br>system. |

Each critical task was evaluated for successful completion and a test case for the critical tasks passes if all participants eventually provided the correct response. Ratings of difficult and close call were analyzed for possible root-cause but were considered to be a pass. Users were asked open-ended questions regarding the device in order to collect subjective feedback on usability aspects that might not have been observed during the objective data collection to seek difficult tasks and safety concerns. Any potential use problem (e.g. use errors, close calls, difficulty, hesitation, etc.) observed during the validation sessions was assessed for root cause and possible outcomes. The root cause of any observed use problems were analyzed for applicability to other critical tasks, harm to patient, and modifications to reduce or eliminate the use problem

The usability of the Hominis Surgical System was evaluated to ensure residual risk is at acceptable levels. If any new hazardous use scenarios were identified during testing, they were assessed according to the risk management process and found to be acceptable.

# Results

Testing included a total of 50 surgeons and 21 OR staff, of which 24 US surgeons and 16 US OR Staff. The validation testing demonstrated all of the identified critical tasks were completed across the different user types within the surgical team, and that all test cases met their acceptance criteria as defined in both protocols by all users. Several cases were determined to be difficult, however upon analysis of the root causes and determination that the clinical consequence caused no harm to patient or minor prolongation of surgical procedure, no new hazardous use scenarios were identified and no modifications to critical tasks were made. The critical tasks identified became a part of the device use training program.

# SUMMARY OF CLINICAL INFORMATION

#### I. Device Use Training Program

A training program was established to mitigate risk of use error that would result in patient injury due to lack of familiarity with the complex systems and functions of Hominis Surgical System.

Before operating the Hominis Surgical System, all users (surgeon and OR Staff) underwent the device use training to properly familiarize and operate the system.

## Investigators Background

The surgeons that participated from Rambam hospital (Haifa, Israel) and Imelda hospital (Bonheiden, Belgium). A total of (0) (4) surgeons participated in the study and operated

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with the system (b) (4)surgeons at Imelda hospital and (b) (4)at Rambam hospital). All surgeons underwent the device use training program for the Hominis Surgical System. Collectively, the surgeons' experience in robotic surgery ranged from 0 to 10 years with three surgeons having never performed robotic procedures independently. The surgeons' experience in vaginal hysterectomies ranged from no experience to 8010 procedures in total: (b)(4) of the surgeons were novice users -(b)(4)had not performed vaginal hysterectomies and (6)(4) surgeon performed (6)(4) vaginal hysterectomies in total prior to using the system. The surgeons' experience in laparoscopic hysterectomies also ranged from no experience to (b) (4) procedures in total; (b) (4) of the surgeons were novice users - (0)(4)had not performed laparoscopic hysterectomies and (b)(4) surgeons performed "" or less laparoscopic hysterectomies in total prior to using the surgical system. The site information and experience per participating surgeon is provided in Table 8.

| Sites and<br>Number | Investigators<br>and roll in the<br>study | Clinical<br>Experience<br>after board<br>certification<br>[Years] | Experience w/<br>vaginal<br>laparoscopic<br>hysterectomy<br>after board<br>certification<br>[Years/No of<br>Operations] | Experience<br>w/laparoscopic<br>hysterectomy<br>after board<br>certification<br>[Years/No of<br>Operations] | Experience<br>w/robotic<br>hysterectomy<br>after board<br>certification<br>[Years/No of<br>Operations] | Number of<br>cases<br>performed as<br>part of the<br>study |
|---------------------|-------------------------------------------|-------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|------------------------------------------------------------|
| Site #1 | (b) (4) | | | | | |
| Site #2 | | | | | | |

| Table 8: Sites Information and Experience per Participating Surgeon | |
|---------------------------------------------------------------------|--|
|---------------------------------------------------------------------|--|

# Training Program Design

The Hominis Surgical System device-specific use training program was a multi-phase. stepwise. human factors-validated program that provided understanding of the Hominis Surgical System, functional understanding of all components, and how each component was used as part of procedural workflow to perform the indicated surgical procedures.

The manufacturer developed and provided the device-specific use training program to the clinical management of the healthcare facilities. Additionally, the manufacturer offered guidance for the logistics and implementation requirements needed to establish the training program at the healthcare facility.

The training program included the following:

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- . Training professional healthcare users to demonstrate proper device setup/use/shutdown through the critical tasks, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error during critical tasks that could result in patient harm due to unfamiliarity with the device features or functions.
- All users met pre-specified success criteria before moving towards clinical cases.
- . Initial clinical cases were proctored.

The Hominis Surgical System may only be distributed to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program.

The device-specific use training program will be updated as part of an evaluation process to maintain an effective training program. This will include the following information:

- . Objective evaluations of users during each training phase to determine user competency and report unanticipated events (e.g. prolonged completion, unexpected performance, difficult tasks, etc.)
- . Feedback on training will be collected from users
- . Complaints and service reports will be periodically reviewed
- . Data collected from clinical studies and post-market surveillance will be periodically reviewed for usability and use error risk analysis

Upon collection of this information, the training plan will be updated accordingly, and training staff appropriately instructed.

#### II. Pre-market Clinical Study

## Purpose/Objectives

The pre-market clinical study:

- Established clinical assessment for the Hominis Surgical System for use in Total । Transvaginal Laparoscopic Hysterectomy with Salpingo-Oophorectomy or Transvaginal Laparoscopic Hysterectomy with Salpingectomy for benign indications.
- Provided clinical endpoints to be compared to the study endpoints from clinical studies found as part of the literature review, to determine a safety and effectiveness profile

## Study Design

A Multi-center, single arm, prospective study was conducted to clinically assess the safety and effectiveness of the Hominis Surgical System for use in Total Transvaginal Laparoscopic Hysterectomy with Salpingo-Oophorectomy or Transvaginal Laparoscopic Hysterectomy with Salpingectomy.

Duration: The total duration for the study was 14 months.

Sample Size: 30 subjects

## Inclusion Criteria

De Novo Summary (DEN190022)

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- 1. Female above 18 years of age, inclusive.
- 2. Able to provide written informed consent.
- 3. Eligible for Total Transvaginal Laparoscopic Hysterectomy with Salpingo-Oophorectomy or Transvaginal Laparoscopic Hysterectomy with Salpingectomy and have an appropriate indication to go through this surgery.
- 4. Willing to undergo laparoscopic transvaginal procedure by Memic Hominis Surgical System.
- 5. Fit for robotic-assisted transvaginal surgery based on surgeon discretion.
-…