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 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 patient-specific 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).

Software algorithms combine tracking information and high-resolution 3D anatomical models to display representations of patient anatomy.

AI/ML Overview

Here's an analysis of the acceptance criteria and study details for the ARAI™ Surgical Navigation System based on the provided FDA 510(k) summary:

The document does not explicitly present a table of acceptance criteria. Instead, it presents the results of performance validation for positional and angular errors. Therefore, the reported device performance is used directly to infer the implied acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

Performance Validation Metric	Implied Acceptance Criteria (Upper Bound)	Reported Device Performance
Positional Error [mm]	$\leq$ 2.49 mm (99% CI Upper Bound)	2.16 mm (Mean)
	$\leq$ 2.41 mm (95% CI Upper Bound)	1.00 mm (Standard deviation)
Angular Error [degrees]	$\leq$ 1.74 degrees (99% CI Upper Bound)	1.49 degrees (Mean)
	$\leq$ 1.68 degrees (95% CI Upper Bound)	0.73 degrees (Standard deviation)
Display Luminance	Met requirements	Demonstrated via testing
Image Contrast	Met requirements	Demonstrated via testing
Latency and Framerate	Met requirements	Demonstrated via testing
Stereoscopic Crosstalk and Contrast	Met requirements	Demonstrated via testing
AR Shutter Frequency	Met requirements	Demonstrated via testing
Spatial Accuracy (AR)	Met requirements	Demonstrated via testing
User Interface and System Display Usability	Met requirements	Evaluated via Human Factors and Usability Testing
Software Segmentation Quality	Compared favorably to manual segmentation	Determined by comparing with manual segmentations (mean Sørensen-Dice coefficient - DSC)
Biocompatibility	Met requirements	Evaluation confirms compliance
Electrical Safety	Compliant with IEC 60601-1:2012	Testing assures compliance
Electromagnetic Compatibility	Compliant with IEC 60601-1-2:2014	Testing assures compliance
Software Verification and Validation	Compliant with FDA Guidance	Performed

2. Sample Sizes Used for the Test Set and Data Provenance

Positional and Angular Error Validation (Surgical Simulations):
- Sample Size: Not explicitly stated in the provided text. The terms "overall 3D positional error" and "overall 3D angular error" are used, but they do not reveal the number of screws measured or the number of cadavers.
- Data Provenance: Prospective, real-world simulation using cadavers ("Surgical simulations conducted on cadavers were performed for system validation."). The country of origin is not specified.
Software Segmentation Quality:
- Sample Size: A "set of test samples presenting lumbosacral spine, extracted from stationary and intraoperative Computed Tomography scans" was used. The exact number of samples is not provided.
- Data Provenance: CT scans (both stationary and intraoperative) of the lumbosacral spine. It is unclear if these were retrospective or prospective, or their country of origin.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Positional and Angular Error Validation: The document describes the ground truth as the "real implants." It does not mention experts establishing the ground truth for this measurement directly, as it's a direct comparison between the virtual and physically placed surgical artifacts.
Software Segmentation Quality: The ground truth was established by "manual segmentations prepared by trained analysts." The number of analysts and their specific qualifications (e.g., years of experience, specific medical specialty) are not provided.

4. Adjudication Method for the Test Set

Positional and Angular Error Validation: Not applicable, as the ground truth derivation is not a subjective consensus process. It's a measurement against a physical reference.
Software Segmentation Quality: The ground truth was established by "manual segmentations prepared by trained analysts." The document does not specify an adjudication method (like 2+1 or 3+1) if multiple analysts were involved or if a single analyst's segmentation was considered the ground truth.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

The provided document does not describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study and therefore does not report an effect size for human readers improving with AI vs. without AI assistance. The performance testing focuses on the device's accuracy in tracking and displaying anatomical structures and instruments.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

Yes, a standalone performance assessment of the algorithm appears to have been conducted, particularly for:
- Positional and Angular Error Validation: This directly quantifies the system's accuracy in representing physical instrument and screw positions relative to the anatomical model, which is an algorithm-driven output.
- Software Segmentation Quality: The "autonomous spine segmentation process" was compared against manual segmentations, indicating a standalone evaluation of the algorithm's performance in this task.

7. The Type of Ground Truth Used

Positional and Angular Error Validation: The ground truth was the "real implants" positioned in cadavers. This is a form of direct physical measurement/outcome data.
Software Segmentation Quality: The ground truth was expert manual segmentation ("manual segmentations prepared by trained analysts").

8. The Sample Size for the Training Set

The document does not specify the sample size used for the training set for any of the algorithms (e.g., for spine segmentation or tracking). It only mentions test samples.

9. How the Ground Truth for the Training Set Was Established

The document does not provide information on how the ground truth for the training set was established, as it does not describe the training process or the dataset used for training. It only details the establishment of ground truth for certain test sets.

Summary

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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

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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

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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.

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)
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K211254

510(k) Summary: ARAI™ Surgical Navigation System

Company:	HOLO SURGICAL, INC.(a subsidiary of Surgalign Spine Technologies)
Contact:	Cristian Luciano, PhDSurgalign Spine Technologies520 Lake Cook Road Suite 315Deerfield, IL 60015630-227-3809
Date Prepared:	January 14, 2022
Proprietary Name:	ARAI™ Surgical Navigation System
Common Name:	Stereotaxic Instrument
Classification:	21 CFR 882.4560, 892.2050Product Code(s): OLO, LLZClass 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:

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Software algorithms combine tracking information and high-resolution 3D anatomical models to display representations of patient anatomy.

Indications for Use:

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.

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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 NavigationSystem	StealthStation S8 with SpineSoftware V1.0.0(Predicate Device)	OpenSight(Reference Device)	xvision Spine(Reference Device)
	displayed 2D stereotaxicinformation.
View(DisplayFeatures)	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
Softwareoperatingprinciple	The ARAI Software functionalityis described in terms of its featuresets which are categorized asimaging modalities, registration,planning, interfaces with medicaldevices, and views. Feature setsinclude functionality thatcontributes to clinical decisionmaking and are necessary toachieve system performance.	StealthStation Spine Softwarefunctionality is described interms of its feature sets whichare categorized as imagingmodalities, registration,planning, interfaces withmedical devices, and views.Feature sets includefunctionality that contributes toclinical decision making andare necessary to achieve systemperformance.	OpenSight uses the HoloLenstechnology to register scannedimages over the patient when userhas OpenSight headset on and inuse. This allows the user to bothsee the patient and through them,with dynamic holograms of thepatient's internal anatomy.OpenSight tools/features includewindow level, segmentation andrendering, registration, motioncorrection, virtual tools, alignment,and the capability to measuredistance and image intensityvalues, such as standardized uptakevalue. OpenSight displaysmeasurement lines, annotations,and regions of interest. 3D images	Xvision Software receives theintraoperative 3D scanner imagesand calculates the registrationbetween the patient's anatomy andthe acquired intraoperative images.then receives tracking informationand displays tracked virtual imagesof the surgical instrument alignedwith the patient on the computermonitor. The optical tracker isembedded into the headset.
Device	ARAI™ Surgical NavigationSystem	StealthStation S8 with SpineSoftware V1.0.0(Predicate Device)	OpenSight(Reference Device)	xvision Spine(Reference Device)
Patient andsurgicalinstrumentstrackingmethod	Optical - infrared 6 DOF	Optical - infrared 6 DOF	Optical - infrared environmentscanning described as HoloLensspatial mapping, process ofmapping real-world surfaces intothe virtual world.include but not limited to tumors,masses, appendices, heart, kidney,bladder, stomach, blood vessels,arteries, and nerves.	Optical - infrared 6 DOF
Registrationfeatures	Automatic 3D Image Registrationperformed after securely placing adevice with passive reflectivemarkers over the patient's anatomyand scanning the surgical fieldwith an intraoperative scanner.	PointMerge RegistrationSurfaceMerge RegistrationFluoroMerge RegistrationAutomatic 2D ImageRegistrationAutomatic 3D ImageRegistration	Registration does not requireinfrared tracking devices or otherfiducials in order to performregistration. Registration of thepatient (reality) to another imagedata set such as MRI or CT(augmented reality) are performedby the OpenSight device whichcontains infrared ranging cameraswhich can map the surfacegeometry of an object creating amesh of triangles conforming towhatever the object is. This caninclude the patient, the surroundingroom, the table, etc. The resolutionof the mesh is controlled by thedevice. For mapping a large objectsuch as a room, a larger meshwould be utilized. Surfacegeometry mapping of a patient'sanatomy utilizes the maximumresolution of the device while theuser may walk around the object ina 360° circle mapping the objectfrom many views in order to obtainthe best localization in space.	Automatic 3D Image Registrationperformed after placing a devicewith passive reflective markers overthe patient's anatomy and scanningthe surgical field with anintraoperative scanner.
Device	ARAI™ Surgical NavigationSystem	StealthStation S8 with SpineSoftware V1.0.0(Predicate Device)	OpenSight(Reference Device)	xvision Spine(Reference Device)
Segmentationand 3D modelgeneration	Voxels of medical datasets(DICOM format) that correspondto the spine are automaticallysegmented and converted to apolygonal mesh for displayingpurposes.	Voxels of medical datasets(DICOM format) thatcorrespond to the spine areautomatically segmented andconverted to a polygonal meshfor displaying purposes.	3D anatomical structures aresegmented from diagnostic CTscans are imported as a DICOMfile format to provide a directvisualization of the patient'sanatomy.	Voxels of medical datasets (DICOMformat) that correspond to the spineare automatically segmented andconverted to a polygonal mesh fordisplaying purposes.
Medicalimagingrendering	Polygonal mesh.	Both polygonal mesh andvolumetric rendering of thespine are shown.	Both polygonal mesh, volumetric,and slice rendering include but notlimited to tumors, masses,appendices, heart, kidney, bladder,stomach, blood vessels, arteries,and nerves.	Both polygonal mesh and volumetricrendering of the spine are shown.
CommunicationbetweenScanner andplatform/computer	Encrypted USB for DICOMimport & export with MedtronicO-arm	Network Connectivity, CD,DVD, USAB, DICOM Import,DICOM Export	WiFi communication with Novoradserver, not a scanner	USB & LAN connectivity usingDICOM

Comparison of the Principles of Operation and Technological Characteristics

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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.

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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.

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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.

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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:

PerformanceValidation	Positional Error [mm]
	Mean	Standarddeviation	95% CIUpper Bound	99% CIUpper 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:

PerformanceValidation	Angular Error [degrees]
	Mean	Standarddeviation	95% CIUpper Bound	99% CIUpper 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
- 1. 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

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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.

Regulation Number and Section

§ 882.4560 Stereotaxic instrument.

(a)
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.(b)
Classification. Class II (performance standards).