Who is the manufacturer of Maestro System (REF100)?

Moon Surgical filed the 510(k) submission for Maestro System (REF100) (K242323).

What is the FDA product code for Maestro System (REF100)?

QZB. It is classified under 21 CFR 876.1500 as a Class 2 device in the Gastroenterology, Urology panel.

What is the regulatory pathway for Maestro System (REF100)?

510(k) clearance (submission type: Traditional).

Does Maestro System (REF100) use AI or machine learning?

Yes. Maestro System (REF100) (K242323) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

Who can help prepare an FDA 510(k) submission like Maestro System (REF100)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Can an AI/ML device like Maestro System (REF100) get a guaranteed FDA 510(k) clearance?

Yes. Innolitics offers a guaranteed FDA 510(k) clearance engagement for AI/ML Software as a Medical Device — combining engineering and regulatory execution under one agreement with a guaranteed clearance outcome. Eligibility: the device must be an AI/ML Software as a Medical Device (SaMD), and its performance must meet the criteria Innolitics determines during an initial regulatory strategy engagement to be necessary for FDA clearance. See https://innolitics.com/services/end-to-end-samd/ or contact https://innolitics.com/contact.

Maestro System (REF100)

Q: What are the predicate devices for Maestro System (REF100)?

Maestro System, Moon Surgical SAS (K240598); Autolap System, Medical Surgery Technologies, Ltd. (K152848).

K242323 · Moon Surgical · QZB · Mar 14, 2025 · Gastroenterology, Urology

Device Facts

Record ID	K242323
Device Name	Maestro System (REF100)
Applicant	Moon Surgical
Product Code	QZB · Gastroenterology, Urology
Decision Date	Mar 14, 2025
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.1500
Device Class	Class 2
Attributes	AI/ML

Intended Use

The Maestro System is intended to hold and position laparoscopes and laparoscopic instruments during laparoscopic surgical procedures.

Device Story

Maestro System is a 2-arm, electro-mechanical, motorized surgical support system. It holds/positions laparoscopes and instruments during laparoscopic procedures. Motors compensate for gravity, maintaining tool position when surgeon force is removed. New 'ScoPilot' feature allows the laparoscope (attached to a Maestro Arm) to automatically follow a designated instrument tip. System inputs include video from the laparoscope camera; processed via frame grabber and image processing algorithms. Algorithms detect tool coordinates and calculate transformation matrices for arm movement. Surgeon remains in control; system follows surgeon-commanded tool movement. Used in OR; operated by surgeons. Benefits include maintained surgical flow and focus. System status indicated via LEDs and touchscreen. Safety features include redundant encoders, velocity/acceleration limits, and automatic brake engagement upon fault.

Clinical Evidence

Bench testing only. No clinical trials were conducted. Validation included payload capacity, force accuracy, system latency, cybersecurity, and electrical safety/EMC. ScoPilot-specific validation used an independent video dataset to verify ML model performance (AP and AR metrics) against predefined specifications. Human factors and cadaver testing were performed to validate system usability and performance in a simulated surgical environment.

Technological Characteristics

Electrically actuated 2-arm system; motorized joints with internal motors and redundant encoders. Materials include mechanical clamps and drapes for sterility. Connectivity includes video input from laparoscope camera. Software-controlled via control unit. Sterilization of coupling devices via Ethylene Oxide (EtO). System utilizes machine learning for tool tip identification and computer vision for tracking. Maximum applied load: 4.4 lbs.

Indications for Use

Indicated for holding and positioning laparoscopes and laparoscopic instruments during laparoscopic surgical procedures in patients undergoing general, gynecologic, or urologic surgery.

Regulatory Classification

Identification

An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Special Controls

*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

Predicate Devices

Maestro System, Moon Surgical SAS (K240598)
Autolap System, Medical Surgery Technologies, Ltd. (K152848)

Related Devices

K250984 — Maestro System (REF100) · Moon Surgical · Jun 27, 2025
K240598 — Maestro System (REF100) · Moon Surgical · Jun 3, 2024
K221410 — Maestro Platform · Moon Surgical · Dec 2, 2022
K152848 — AUTOLAP SYSTEM · M.S.T Medical Surgery Technologies, Ltd. · Nov 17, 2015
K973249 — ENDOASSIST · Armstrong Healthcare , Ltd. · Nov 26, 1997

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services - USA seal. To the right of the seal is the FDA logo in blue. The logo includes the words "U.S. FOOD & DRUG ADMINISTRATION". March 14, 2025 Moon Surgical % Michael Daniel Consultant Daniel & Daniel Consulting P.O. Box 129 Minden, Nevada 89423 Re: K242323 Trade/Device Name: Maestro System (REF100) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: QZB Dated: January 14, 2025 Received: January 15, 2025 Dear Michael Daniel: We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {1}------------------------------------------------ Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory {2}------------------------------------------------ assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Digitally signed by Mark Mark Trumbore -S Date: 2025.03.14 15:18:19 Trumbore -S -04'00' Mark Trumbore, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ # Indications for Use Submission Number (if known) K242323 Device Name Maestro System (REF100) Indications for Use (Describe) The Maestro System is intended to hold and position laparoscopes and laparoscopic instruments during laparoscopic surgical procedures. Type of Use (Select one or both, as applicable) Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Moon Surgical. The logo features a stylized depiction of a moon, with the upper portion shaded to represent craters or lunar features. Below the moon graphic, the word "MOON" is written in a simple, sans-serif font, with the word "SURGICAL" appearing beneath it in a smaller font size. ## 510(k) Number: K242323 ## Applicant Information: | Date Prepared: | March 10, 2025 | |---------------------|------------------------------| | Name: | Moon Surgical | | Address: | 9 rue d'Enghien | | | 75010 Paris France | | Contact Person: | Michael A Daniel, Consultant | | | madaniel@clinregconsult.com | | Mobile Number: | (415) 407-0223 | | Device Information: | | | Device Trade Name: | Maestro System | | Common Name: | Maestro System | - Classification Name(s): Endoscope And Accessories - Product Code/ Regulation: QZB 21 CFR 876.1500 - Classification: Class II ## Predicate Device: Maestro System, Moon Surgical SAS (K240598) - Autolap System, Medical Surgery Technologies, Ltd. (K152848) ### Subject Device Description The Moon Maestro System is a 2-arm system which utilizes software and hardware to provide support to surgeons for manipulating and maintaining instrument position. Motors compensate for gravitational force applied to laparoscopic instruments, while surgeon control is not affected. Conventional laparoscopic tools are exclusively controlled and maneuvered by the surgeon, who grasps the handle of the surgical laparoscopic instrument and moves it freely until the instrument {5}------------------------------------------------ is brought to the desired position. Once surgeon hand force is removed, the Maestro system reverts to maintenance of the specified tool position and instrument tip location. This 510(k) is being submitted to implement the ScoPilot feature. ScoPilot is an on-demand, optional, ease-of-use feature of the Maestro System, allowing the laparoscope which is attached to a Maestro Arm to seamlessly follow a desired instrument tip. The surgeon remains in control of laparoscope positioning, without having to disengage from the instrument in their hand, helping maintain surgical flow and focus. #### Subject Device Intended Use / Indications for Use The Maestro System is intended to hold and position laparoscopes and laparoscopic instruments during laparoscopic surgical procedures. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Moon Surgical. The logo consists of a stylized image of a moon with some craters on the surface. Below the moon image, the word "MOON" is written in a simple sans-serif font, and below that, the word "SURGICAL" is written in a smaller font. 510(k) summary # Predicate Device and Subject Device Comparison The table below compares the Maestro System to the predicate devices. | ASPECT | MOON SURGICAL (Subject Device) | MOON SURGICAL (Primary predicate Device) | MST - MEDICAL SURGERY TECHNOLOGIES LTD (Secondary predicate device) | COMPARISON | |------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------| | Device Name | Maestro System | Maestro System | Autolap System | N/A | | 510(k) Number | Not yet assigned | K221410 | K152848 | N/A | | Product Code / | QZB / 876.1500 Endoscope | FQO / 878.4960 | GCJ / 876.1500 | Identical to 2nd | | Regulation | And Accessories | Table Operating-room, Ac- Powered. | Endoscope And Accessories | predicate | | Brief Description | The Moon Surgical Maestro device is an electrically actuated device with movable components intended for laparoscopic surgical procedures to support and position laparoscopic instruments. | Same | The Autolap system is a compact image guided laparoscope manipulator that is designed to hold and position the laparoscope during laparoscopic surgery. Its role is to hold and move the laparoscope under the direct control of surgeon. | Substantially equivalent | | Intended Use / Indications for Use | The Maestro System is intended to hold and position laparoscopic Instruments during laparoscopic surgical procedures. | Same | [The Autolap is used] for the purpose of holding and controlling the movement of a standard laparoscope or rigid endoscope for General laparoscopic, Gynecologic and Urologic procedures | Substantially equivalent | | Technological characteristics | | | | | | System basic components | Two motorized Arms that hold and position the laparoscope and/or laparoscopic instruments | Same | A motorized Arm that holds and positions the laparoscope (the Autolap ARM) A control unit that controls the | Substantially equivalent | | ASPECT | MOON SURGICAL (Subject Device) | MOON SURGICAL (Primary predicate Device) | MST - MEDICAL SURGERY TECHNOLOGIES LTD (Secondary predicate device) | COMPARISON | | | Two stages, supporting and positioning the arms A Control Unit that controls the movements of the arms Instrument Coupling A User interface for system setup and feature selection | | movements of the ARM A positioning unit connecting the Arm to the operation bed rail on either side A hand-controlled Command Unit that enables the surgeon to move the laparoscope to his/her chosen target location Instrument coupling | | | Method of instrument attachment | Mechanical clamp around laparoscopic instrument and mechanical attachment to arm | Same | Same | Identical | | Mechanisms involved in physical positioning | Electro-mechanical jointed arms driven by internal motors that follow the physician movements. | Same | Same | Identical | | Method of control | Movement of the laparoscope is enabled only upon applied force to the instrument handle. Endoscope can optionally be controlled by selected handheld instruments with Endoscope following instrument tip. | Movement of the laparoscope is enabled only upon applied force to the instrument handle. | Movement of the laparoscope is enabled only upon pressing the button on the joystick command or the Manual Activation Button or be guided by the movement of a designated tool within the field of view. | Substantially equivalent | | Endoscope Movement | Manual Control Control algorithm applying motor current for instrument motion triggered by physician direct movement Instrument Based Control | Manual Control Control algorithm applying motor current for instrument motion triggered by physician direct movement | Manual Control Control algorithm applying motor current for instrument at motion triggered by physician direct movement | Substantially equivalent | | ASPECT | MOON SURGICAL (Subject Device) | MOON SURGICAL (Primary predicate Device) | MST - MEDICAL SURGERY TECHNOLOGIES LTD (Secondary predicate device) | COMPARISON | | | Image processing algorithms that enable the detection of all surgical tools within the displayed video image and when commanded by the surgeon, follow the movement of the chosen tool. | | Instrument Based Control image processing algorithms that enable the detection of all surgical tools within the displayed video image and when commanded by the surgeon, follow the movement of the chosen tool. Joystick control indirect instrument movement communicated via RF signal. | | | Video Image Handling | The video image is transferred from the laparoscope camera unit, through the frame grabber, to the Image Processing Algorithm | N/A | The video image is transferred from the laparoscope camera unit, through the frame grabber, to the Image Processing Algorithm | Substantially equivalent | | Image Processing Algorithm | The Image Processing Algorithm continuously detects the coordinates of the surgical tools within the video image. Additionally, it calculates the transformation matrix, which correlates to the laparoscope's movement from image to image | N/A | The Image Processing Algorithm continuously detects the coordinates of the surgical tools within the video image. Additionally, it calculates the transformation matrix, which correlates to the laparoscope's movement from image to image | Substantially equivalent | | Instrument tip identification | Machine Learning methodology used to develop | N/A | Computer Vision methodology used to develop | Substantially equivalent | | ASPECT | MOON SURGICAL (Subject Device) | MOON SURGICAL (Primary predicate Device) | MST - MEDICAL SURGERY TECHNOLOGIES LTD (Secondary predicate device) | COMPARISON | | software algorithm development method | software algorithm responsible for identifying tool tip. Once developed, this software algorithm is fixed and static and added to the rest of the system software. | | software algorithm responsible for identifying tool tip. Once developed, this software algorithm is fixed and static and added to the rest of the system software. | | | Alarm and Warning Condition Indicators | The arms and lighthouse of the Maestro System are equipped with eight LEDs that convey information about the system's status and conditions. If necessary, alerts, notifications, and fault messages or graphics are displayed on the Touchscreen simultaneously to indicate the system's current status. | Same | Alerts, notifications, and fault messages are displayed on the screen to indicate the system's current status. | Substantially equivalent | | Single Fault Tolerance | Automatic System Performance Monitoring in real-time with multiple fault tiers + visual supervision by surgeon via LED indicating system status. Examples include: - Redundant encoders on motorized axes - Velocity, acceleration, | Same | Searching redacted 510(k) for "single fault" of "fault" does not yield useful information. Moon Surgical does not know about their design in this regard other than the following: "Motor current limitation - applying relatively heavy weight on the ARM will cause | Substantially equivalent | | ASPECT | MOON SURGICAL (Subject Device) | MOON SURGICAL (Primary predicate Device) | MST - MEDICAL SURGERY TECHNOLOGIES LTD (Secondary predicate device) | COMPARISON | | | current and torque limits Brakes engage if power is removed | | the motors' currents to rise above a pre-defined threshold. As a response the system will electronically shutdown the motors and no motorized movement will be enabled." | | | Back-up fault response | Brakes engage on motorized axis in the event of a fault state to prohibit any arm motion | Same | No information | Substantially equivalent | | Maximum Applied Load | 4.4 lbs tested. | Same | 600 grams | Substantially equivalent | | Compatible with | 5mm and 10mm laparoscopes and laparoscopic instruments 5mm and 10mm laparoscopes for Scopilot | 5mm and 10mm laparoscopes and laparoscopic instruments | 5mm and 10mm laparoscopes | Substantially equivalent | | Sterilization Method | Ethylene Oxide (EtO) – for coupling devices used to attach laparoscopic instruments | Same | Ethylene Oxide (EtO) | Substantially equivalent | | Sterility barrier | Drape | Drape | Drape | Identical | {7}------------------------------------------------ {8}------------------------------------------------ {9}------------------------------------------------ {10}------------------------------------------------ {11}------------------------------------------------ Image /page/11/Picture/0 description: The image shows the logo for Moon Surgical. The logo features a stylized image of a moon or globe at the top, with the word "MOON" in large, sans-serif font below it. Underneath "MOON" is the word "SURGICAL" in a smaller, sans-serif font. #### 510(k) summary ## Testing Performed Testing described in this 510(k) consisted of verification of the Scopilot input requirements and product specifications. All requirements were validated. Design verification testing included the following: - Payload Capacity - Malformed Input - Force Accuracy - · Drape Integrity - · Emergency Stop - Hold Position Accuracy - · IFU Inspection - Positioning Guidance & Collision Detection - · ScoPilot Motion Performance - System Positioning Accuracy - Bedside Joint Control Accuracy - End to End Workflow - · Design Inspection - · System Setup - · System Latency - Electro-Cautery Compatibility - · ScoPilot Latency - ScoPilot End to End - ScoPilot IFU Inspection - · System Endurance - ScoPilot Vision Performance - ScoPilot Malformed Input - · Cybersecurity - Coupler Performance - · Electrical safety and electromagnetic compatibility (EMC) ## Software Verification and Validation Testing Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Content of Premarket {12}------------------------------------------------ Submissions for Device Software Functions" and "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions". Software testing included testing the software modifications made to implement the new ScoPilot features. This includes detection and tracking of specified instrument tips, generation of motion trajectories, safety limits and detection of malformed inputs at a video and frame level. ### ScoPilot Validation testing The ML model was trained and tuned through a K-fold cross-tuning process to optimize hyperparameters, until it reached our predefined performance requirements. An independent testing dataset containing videos was used to verify that the model performance (lower bound of the 95%CI for AP and AR) is compliant with our specification when using data including brands unseen during training/tuning. Design validation testing included the following: - · Human factors testing - · Cadaver testing ### Summary Based upon the Intended Use, Indications for Use, product technical information, performance evaluation, and standards compliance provided in this premarket notification, the Maestro System has been shown to be substantially equivalent to the cited predicate devices.