Who is the manufacturer of ARAI Surgical Navigation System?

Surgalign Spine Technologies filed the 510(k) submission for ARAI Surgical Navigation System (K211254).

What is the FDA product code for ARAI Surgical Navigation System?

SBF. It is classified under 21 CFR 882.4560 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for ARAI Surgical Navigation System?

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

Does ARAI Surgical Navigation System use AI or machine learning?

Yes. ARAI Surgical Navigation System (K211254) 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 ARAI Surgical Navigation System?

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 ARAI Surgical Navigation System 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.

ARAI Surgical Navigation System

Q: What are the predicate devices for ARAI Surgical Navigation System?

StealthStation S8 Spine Software V1.0.0 (K170011).

K211254 · Surgalign Spine Technologies · SBF · Jan 14, 2022 · Neurology

Device Facts

Record ID	K211254
Device Name	ARAI Surgical Navigation System
Applicant	Surgalign Spine Technologies
Product Code	SBF · Neurology
Decision Date	Jan 14, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.4560
Device Class	Class 2
Attributes	AI/ML

Intended Use

The ARAI™ System is intended as an aid for precisely locating anatomical structures in either open or percutaneous orthopedic procedures in the lumbosacral spine region. Their use is indicated for any medical condition of the lumbosacral spine in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the iliac crest, can be identified relative to intraoperative CT images of the anatomy. The ARAI System simultaneously displays 2D stereotaxic data along with a 3D virtual anatomy model over the patient during surgery. The stereotaxic display is indicated for continuously tracking instrument position and orientation to the registered patient anatomy while the 3D display is indicated for localizing the virtual instrument to the virtual anatomy model over the patient during surgery. The 3D display should not be relied upon solely for absolute positional information and should always be used in conjunction with the displayed 2D stereotaxic information.

Device Story

ARAI Surgical Navigation System provides intraoperative visualization and guidance for lumbosacral spine procedures. System inputs include patient-specific DICOM CT images and real-time optical tracking data. Optical tracker uses infrared cameras/active infrared lights to triangulate 3D position/orientation of passive markers on instruments and patient anatomy. Software processes these inputs to generate 2D stereotaxic views and 3D virtual anatomy models. Output displayed on workstation monitors and via optional augmented reality (AR) headset. Used in OR by surgeons to assist in pedicle screw placement. AR visualization overlays virtual anatomy on patient; 3D display intended as supplemental guidance to 2D stereotaxic data. Benefits include improved surgical precision and trajectory planning. System consists of surgeon workstation (display/AR visor) and control workstation (tracker/computer).

Clinical Evidence

No human clinical trials. Evidence based on bench testing and cadaveric surgical simulations. Cadaver study measured 3D positional error (Mean 2.16mm, 95% CI 2.41mm) and angular error (Mean 1.49°, 95% CI 1.68°). Software validation compared autonomous spine segmentation against manual segmentation using Sørensen-Dice coefficient (DSC). Bench testing included tracking accuracy per ASTM F2554-18 and AR technical performance (latency, framerate, spatial accuracy).

Technological Characteristics

Optical infrared 6-DOF tracking system. Components: surgeon workstation, control workstation, AR headset. Software performs autonomous 3D segmentation of DICOM CT data into polygonal meshes. Connectivity: Encrypted USB for DICOM import/export. Standards: IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), IEC 60601-1-6 (usability), ASTM F2554-18 (tracking accuracy).

Indications for Use

Indicated for patients undergoing open or percutaneous orthopedic lumbosacral spine procedures where stereotactic surgery is appropriate and rigid anatomical structures (e.g., iliac crest) can be referenced to intraoperative CT images.

Regulatory Classification

Identification

A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.

Predicate Devices

StealthStation S8 Spine Software V1.0.0 (K170011)

Reference Devices

OpenSight (K172418)
xvision Spine (K190929)
Streamline Navigated Instruments (K200095)
Streamline TL Spinal Fixation System (K192800)
Streamline MIS Spinal Fixation System (K192396)

Related Devices

K231611 — HOLO Portal Surgical Guidance System · Surgalign Spine Technologies · Aug 31, 2023
K220905 — xvision Spine System · Augmedics, Ltd. · Nov 17, 2022
K241870 — OnPoint Augmented Reality Spine System · Onpoint Surgical, Inc. · Aug 19, 2024
K233725 — Spine Navigation System · Medivis, Inc. · Jul 26, 2024
K242271 — Caduceus S · Taiwan Main Orthopaedic Biotechnology Co., Ltd. · Oct 30, 2024

Submission Summary (Full Text)

{0}------------------------------------------------ January 14, 2022 Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. Surgalign Spine Technologies Cristian Luciano Vice President of Research and Development 520 Lake Cook Road, Suite 315 Deerfield, Illinois 60015 # Re: K211254 Trade/Device Name: ARAI Surgical Navigation System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO, LLZ Dated: December 14, 2021 Received: December 15, 2021 # Dear Cristian Luciano: 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 (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 located 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. 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 {1}------------------------------------------------ 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 mediation-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-regulatoryassistance/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, For: Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair, and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K211254 Device Name ARAITM Surgical Navigation System #### Indications for Use (Describe) The ARAI™ System is intended as an aid for precisely locating anatomical structures in either open or percutaneous orthopedic procedures in the lumbosacral spine region. Their use is indical condition of the lumbosacral spine in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the iliac crest, can be identified relative to intraoperative CT images of the anatomy. The ARAI System simultaneously displays 2D stereotaxic data along with a 3D virtual anatomy model over the patient during surgery. The stereotaxic display is indicated for continuously tracking instrument position and orientation to the registered patient anatomy while the 3D display is indicated for localizing the virtual instrument to the virtual anatomy model over the patient during surgery. The 3D display should not be relied upon solely for absolute positional information and should always be used in conjunction with the displayed 2D stereotaxic information. 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." {3}------------------------------------------------ # K211254 # 510(k) Summary: ARAI™ Surgical Navigation System | Company: | HOLO SURGICAL, INC. (a subsidiary of Surgalign Spine Technologies) | |-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact: | Cristian Luciano, PhD Surgalign Spine Technologies 520 Lake Cook Road Suite 315 Deerfield, IL 60015 630-227-3809 | | Date Prepared: | January 14, 2022 | | Proprietary Name: | ARAI™ Surgical Navigation System | | Common Name: | Stereotaxic Instrument | | Classification: | 21 CFR 882.4560, 892.2050 Product Code(s): OLO, LLZ Class II | | Primary Predicate: | StealthStation S8 Spine Software V1.0.0 (K170011) | | Reference Devices(s): | OpenSight (K172418) xvision Spine (K190929) Streamline Navigated Instruments (K200095) Streamline TL Spinal Fixation System (K192800) Streamline MIS Spinal Fixation System (K192396) | ## Purpose: The purpose of this submission is to request clearance of the HoloSurgical® ARAI™ Surgical Navigation System in either open or percutaneous orthopedic spine pedicle screw procedures. # Product Description: The ARAI™ System is a combination of hardware and software that provides visualization of the patient's internal boney anatomy and surgical guidance to the surgeon based on registered patientspecific digital imaging. ARAI™ is a navigation system for surgical planning and/or intraoperative guidance during stereotactic surgical procedures. The ARAI™ system consists of two mobile devices: 1) the surgeon workstation, which includes the display unit and the augmented reality visor (optional), and 2) the control workstation, which houses the optical navigation tracker and the computer. The optical navigation tracker utilizes infrared cameras and active infrared lights to triangulate the 3D location of passive markers attached to each system component to determine their 3D positions and orientations in real time. The 3D scanned data is displayed with both 2D images and 3D virtual models along with tracking information on computer mounted on workstations near the patient bed and a dedicated projection display mounted over the patient. Augmented reality is accomplished with the 3D virtual models being viewed with dedicated headset(s). {4}------------------------------------------------ Software algorithms combine tracking information and high-resolution 3D anatomical models to display representations of patient anatomy. ### Indications for Use: The ARAI™ System is intended as an aid for precisely locating anatomical structures in either open or percutaneous orthopedic procedures in the lumbosacral spine region. Their use is indicated for any medical condition of the lumbosacral spine in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the iliac crest, can be identified relative to intraoperative CT images of the anatomy. The ARAI System simultaneously displays 2D stereotaxic data along with a 3D virtual anatomy model over the patient during surgery. The stereotaxic display is indicated for continuously tracking instrument position and orientation to the registered patient anatomy while the 3D display is indicated for localizing the virtual instrument to the virtual anatomy model over the patient during surgery. The 3D display should not be relied upon solely for absolute positional information and should always be used in conjunction with the displayed 2D stereotaxic information. ### Technological Characteristics: The ARAI™ System has the same design, materials, performance characteristics, and the same or equivalent labeling. The ARAI™ System is comparable to the predicate in terms of intended use, fundamental scientific technology, technological characteristics, and principle of operation. {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for Holosurgical. The logo consists of a blue stylized letter "H" on the left, followed by the word "HOLOSURGICAL" in blue, with a small "TM" symbol in brown to the right of the word. The letter "H" is made up of several geometric shapes, giving it a modern and technological look. | Device | ARAI™ Surgical Navigation System | StealthStation S8 with Spine Software V1.0.0 (Predicate Device) | OpenSight (Reference Device) | xvision Spine (Reference Device) | |------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) number | Subject Device | K170011 | K172418 | K190929 | | Product code | OLO, LLZ | OLO | LLZ | OLO | | Indications for Use | The ARAI™ System is intended as an aid for precisely locating anatomical structures in either open or percutaneous orthopedic procedures in the lumbosacral spine region. Their use is indicated for any medical condition of the lumbosacral spine in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the iliac crest, can be identified relative to intraoperative CT images of the anatomy. The ARAI System simultaneously displays 2D stereotaxic data along with a 3D virtual anatomy model over the patient during surgery. The stereotaxic display is indicated for continuously tracking instrument position and orientation to the registered patient anatomy while the 3D display is indicated for localizing the virtual instrument to the virtual anatomy model over the patient during surgery. The 3D display should not be relied upon solely for absolute positional information and should always be | The StealthStation System, with StealthStation Spine Software, is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical and orthopedic procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the spine or pelvis, can be identified relative to images of the anatomy. This can include the following spinal implant procedures, such as: Pedicle Screw Placement Iliosacral Screw Placement Interbody Device Placement | OpenSight is intended to enable users to display, manipulate, and evaluate 2D, 3D, and 4D digital images acquired from CR, DX, CT, MR, and PT sources. It is intended to visualize 3D imaging holograms of the patient, on the patient, for preoperative localization and pre-operative planning of surgical options. OpenSight is designed for use only with performance-tested hardware specified in the user documentation. OpenSight is intended to enable users to segment previously acquired 3D datasets, overlay, and register these 3D segmented datasets with the same anatomy of the patient in order to support pre-operative analysis. OpenSight is not intended for intraoperative use. It is not to be used for stereotactic procedures. OpenSight is intended for use by trained healthcare professionals, including surgeons, radiologists, chiropractors, physicians, cardiologists, technologists, and medical educators. The device assists doctors to better understand | The xvision Spine System, with xvision Spine System Software, is intended as an aid for precisely locating anatomical structures in either open or percutaneous spine procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the spine, can be identified relative to CT imagery of the anatomy. This can include the spinal implant procedures, such as Posterior Pedicle Screw Placement in the thoracic and sacro-lumbar region. The Headset of the xvision Spine System displays 2D stereotaxic screens and a virtual anatomy screen. The stereotaxic screen is indicated for correlating the tracked instrument location to the registered patient imagery. The virtual screen is indicated for displaying the virtual instrument location in relation to the virtual anatomy to assist in percutaneous visualization and trajectory planning. The virtual display should not be relied upon solely for absolute positional information and should always be | | Device | ARAI™ Surgical Navigation System | StealthStation S8 with Spine Software V1.0.0 (Predicate Device) | OpenSight (Reference Device) | xvision Spine (Reference Device) | | | displayed 2D stereotaxic information. | | | | | View (Display Features) | 2D axial, sagittal, and coronal 3D anatomical model Mesh Mode 3D, 2D anatomic orthogonal planes Trajectories Trajectory guidance Look Ahead Instrument's tip view Clipping tool Image Intensity 3D transparent User defined Implant AR OFF (3D OFF) | Look Sideways 3D Anatomic orthogonal Trajectory 1 and 2 Trajectory Guidance Look Ahead Probe's Eye AP and Lateral Synthetic AP and Lateral Maximum Intensity Projection (MIP) Video input | Normal Mode Volume Mode Alignment Mode Slice Mode | 2D images: axial and sagittal 3D anatomical model Trajectories Trajectory guidance Instrument's tip view 3D transparent 3D OFF (only 2D) 3D follow instrument movement | | Software operating principle | The ARAI Software functionality is described in terms of its feature sets which are categorized as imaging modalities, registration, planning, interfaces with medical devices, and views. Feature sets include functionality that contributes to clinical decision making and are necessary to achieve system performance. | StealthStation Spine Software functionality is described in terms of its feature sets which are categorized as imaging modalities, registration, planning, interfaces with medical devices, and views. Feature sets include functionality that contributes to clinical decision making and are necessary to achieve system performance. | OpenSight uses the HoloLens technology to register scanned images over the patient when user has OpenSight headset on and in use. This allows the user to both see the patient and through them, with dynamic holograms of the patient's internal anatomy. OpenSight tools/features include window level, segmentation and rendering, registration, motion correction, virtual tools, alignment, and the capability to measure distance and image intensity values, such as standardized uptake value. OpenSight displays measurement lines, annotations, and regions of interest. 3D images | Xvision Software receives the intraoperative 3D scanner images and calculates the registration between the patient's anatomy and the acquired intraoperative images. then receives tracking information and displays tracked virtual images of the surgical instrument aligned with the patient on the computer monitor. The optical tracker is embedded into the headset. | | Device | ARAI™ Surgical Navigation System | StealthStation S8 with Spine Software V1.0.0 (Predicate Device) | OpenSight (Reference Device) | xvision Spine (Reference Device) | | Patient and surgical instruments tracking method | Optical - infrared 6 DOF | Optical - infrared 6 DOF | Optical - infrared environment scanning described as HoloLens spatial mapping, process of mapping real-world surfaces into the virtual world. include but not limited to tumors, masses, appendices, heart, kidney, bladder, stomach, blood vessels, arteries, and nerves. | Optical - infrared 6 DOF | | Registration features | Automatic 3D Image Registration performed after securely placing a device with passive reflective markers over the patient's anatomy and scanning the surgical field with an intraoperative scanner. | PointMerge Registration SurfaceMerge Registration FluoroMerge Registration Automatic 2D Image Registration Automatic 3D Image Registration | Registration does not require infrared tracking devices or other fiducials in order to perform registration. Registration of the patient (reality) to another image data set such as MRI or CT (augmented reality) are performed by the OpenSight device which contains infrared ranging cameras which can map the surface geometry of an object creating a mesh of triangles conforming to whatever the object is. This can include the patient, the surrounding room, the table, etc. The resolution of the mesh is controlled by the device. For mapping a large object such as a room, a larger mesh would be utilized. Surface geometry mapping of a patient's anatomy utilizes the maximum resolution of the device while the user may walk around the object in a 360° circle mapping the object from many views in order to obtain the best localization in space. | Automatic 3D Image Registration performed after placing a device with passive reflective markers over the patient's anatomy and scanning the surgical field with an intraoperative scanner. | | Device | ARAI™ Surgical Navigation System | StealthStation S8 with Spine Software V1.0.0 (Predicate Device) | OpenSight (Reference Device) | xvision Spine (Reference Device) | | Segmentation and 3D model generation | Voxels of medical datasets (DICOM format) that correspond to the spine are automatically segmented and converted to a polygonal mesh for displaying purposes. | Voxels of medical datasets (DICOM format) that correspond to the spine are automatically segmented and converted to a polygonal mesh for displaying purposes. | 3D anatomical structures are segmented from diagnostic CT scans are imported as a DICOM file format to provide a direct visualization of the patient's anatomy. | Voxels of medical datasets (DICOM format) that correspond to the spine are automatically segmented and converted to a polygonal mesh for displaying purposes. | | Medical imaging rendering | Polygonal mesh. | Both polygonal mesh and volumetric rendering of the spine are shown. | Both polygonal mesh, volumetric, and slice rendering include but not limited to tumors, masses, appendices, heart, kidney, bladder, stomach, blood vessels, arteries, and nerves. | Both polygonal mesh and volumetric rendering of the spine are shown. | | Communication between Scanner and platform/ computer | Encrypted USB for DICOM import & export with Medtronic O-arm | Network Connectivity, CD, DVD, USAB, DICOM Import, DICOM Export | WiFi communication with Novorad server, not a scanner | USB & LAN connectivity using DICOM | # Comparison of the Principles of Operation and Technological Characteristics {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Holosurgical. The logo consists of a blue stylized letter H on the left, followed by the word "HOLOSURGICAL" in blue, sans-serif font. To the right of the word is the letters "TM" in a smaller font size. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for Holosurgical. The logo consists of a blue stylized letter H on the left, followed by the word "HOLOSURGICAL" in blue. The letters are all capitalized, and there is a small "TM" symbol in the upper right corner of the word. {8}------------------------------------------------ Image /page/8/Picture/1 description: The image shows the logo for Holosurgical. The logo consists of a blue stylized letter H on the left, followed by the word "HOLOSURGICAL" in blue, sans-serif font. A small "TM" symbol is located to the right of the word. {9}------------------------------------------------ Image /page/9/Picture/1 description: The image shows the logo for Holosurgical. The logo consists of a blue stylized letter H on the left, followed by the word "HOLOSURGICAL" in blue. To the right of the word "HOLOSURGICAL" is the letters "TM" in a smaller font size. ## Performance Testing: Verification and validation testing was conducted on ARAI™ Surgical Navigation System to confirm that the device meets performance requirements under the indications for use and to ensure equivalent safety and efficacy of the system to the cited predicate devices: - . Non-clinical system, software, and instrument verification and validation - demonstrated compliance with user needs and corresponding design inputs. - . Surgical simulations conducted on cadavers were performed for system validation. The positional displacement is measured as the 3D (Euclidean) distance between the tips of the virtual and real implants, and the angular axis displacement is measured as the angle between the 3D trajectories of the virtual and real implants. The overall 3D positional error measured in [mm] between the real and virtual pedicle screws for performance validation is summarized below: | Performance Validation | Positional Error [mm] | | | | |---------------------------|-----------------------|-----------------------|-----------------------|-----------------------| | | Mean | Standard deviation | 95% CI Upper Bound | 99% CI Upper Bound | | ARAI System | 2.16 | 1.00 | 2.41 | 2.49 | The overall 3D angular error measured in degrees between the real and virtual pedicle screws for performance validation is summarized below: | Performance Validation | Angular Error [degrees] | | | | |---------------------------|-------------------------|-----------------------|-----------------------|-----------------------| | | Mean | Standard deviation | 95% CI Upper Bound | 99% CI Upper Bound | | ARAI System | 1.49 | 0.73 | 1.68 | 1.74 | Additionally, bench top testing included tracking accuracy testing using phantoms and subsystem testing per ASTM F2554-18. - Augmented Reality technical characteristics were demonstrated via performance testing . of display luminance, image contrast, latency and framerate, stereoscopic crosstalk and contrast, AR shutter frequency, and spatial accuracy (a measurement of disparity between the visualization of a real and virtual objects) under varying user conditions. - Human factors and usability testing was conducted to evaluate the user interface and the ● system display in the intended user environment. - Compliance conformity assessments per: - IEC 60601-1 Medical electrical equipment. General requirements for basic 1. safety and essential performance - 2. IEC 60601-1-2 Medical electrical equipment. General requirements for basic safety and essential performance - Electromagnetic disturbances - IEC 60601-1-6 Medical Electrical Equipment Part 1-6, General Requirements 3. for Basic Safety and Essential Performance - Usability ## Biocompatibility: The biocompatibility evaluation for ARAI™ Surgical Navigation System has been conducted in accordance with FDA Guidance for Industry and FDA Staff, "Use of International Standard ISO 10993-1, 'Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows the logo for Holosurgical. The logo consists of a blue stylized letter H on the left, followed by the word "HOLOSURGICAL" in blue. The letters are a sans-serif font, and the letters are evenly spaced. To the right of the word is the trademark symbol. management process'," June 16, 2016. The evaluation confirms that ARAI™ Surgical Navigation System meets biocompatibility requirements. ### Electrical Safety and Electromagnetic Compatibility: Testing was performed to assure compliance with recognized safety standard, IEC 60601-1:2012 standard for electrical safety and electromagnetic compatibility, IEC 60601-1-2:2014. #### Software Verification and Validation Testing: Software validation and verification testing was performed in accordance with the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005). A set of test samples presenting lumbosacral spine, extracted from stationary and intraoperative Computed Tomography scans was subjected to the autonomous spine segmentation process performed by the ARAI Spine Software. The quality of the autonomous anatomical segmentation applied by the ARAI Surgical Navigation System was determined by comparing it with manual segmentations prepared by trained analysts based on mean Sørensen-Dice coefficient (DSC) calculations. ### Basis of Substantial Equivalence: ARAI™ Surgical Navigation System has been found to be substantially equivalent to the predicate device with respect to technical characteristics, performance, and intended use. The reference predicate devices were relied upon to identify applicable test methods associated with AR technology. The information provided within this premarket notification supports the substantial equivalence to the cited predicate devices.