SpineAR SNAP is intended for use or pre-operative surgical planning on-screen and in a virtual environment, and intraoperative surgical planning and visualization on-screen and in an augment using the HoloLens2 and Magic Leap 1 AR headset displays with validated navigation systems as identified in the device labeling.

SpineAR SNAP is indicated for spinal stereotaxic surgery, and where reference to a rigid anatomical structure, such as the spine, can be identified relative to images of the anatomy. SpineAR is intended for use in spinal implant procedures, such as Pedicle Screw Placement, in the lumbar and thoracic regions with the Magic Leap 1 AR headset, and in the lumbar region with the HoloLens2 AR headset.

The virtual 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 SpineAR SNAP does not require any custom hardware and is a software-based device that runs on a high-performance desktop PC assembled using "commercial off-the-shelf" components that meet minimum performance requirements.

The SpineAR SNAP software transforms 2D medical images into a dynamic interactive 3D scene with multiple point of views for viewing on a high-definition (HD) touch screen monitor. The surgeon prepares a pre-operative plan for stereotaxic spine surgery by inserting guidance objects such as directional markers and virtual screws into the 3D scene. Surgical planning tools and functions are available on-screen and when using a virtual reality (VR) headset. The use of a VR headset for preoperative surgical planning further increases the surgeon's immersion level in the 3D scene by providing a 3D stereoscopic display of the same 3D scene displayed on the touch screen monitor.

By interfacing to a 3rd party navigation system such as a Medtronic StealthStation S8, the SpineAR SNAP extracts the navigation data (i.e. tool position and orientation) and presents the navigation data into the advanced interactive, high quality 3D image, with multiple point of views on a high-definition (HD) touch screen monitor. Once connected, the surgeon can then execute the plan through the intraoperative use of the SpineAR SNAP's enhanced visualization and guidance tools.

The SpineAR SNAP supports three (3) guidance options from which the surgeon selects the level of guidance that will be shown in the 3D scene. The guidance options are dotted line (indicates deviation distance), orientation line (indicates both distance and angular deviation), and ILS (indicates both distance and angular deviation using crosshairs). Visual color-coded cues indicate alignment of the tracker tip to the guidance object (e.g. green = aligned).

The 3D scene with guidance tools can also be streamed into an AR wireless headset (Magic Leap 1 or HoloLens2) worn by the surgeon during surgery. The 3D scene and guidance shown within the AR headset is projected above the patient and does not obstruct the surgeons view of the surgical space.

AI/ML Overview

The provided text describes the SpineAR SNAP device and its performance data to establish substantial equivalence for FDA 510(k) clearance. Here's a breakdown of the requested information based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the "System Accuracy Requirements" section and the "Performance Data" section.

Acceptance Criteria	Reported Device Performance
Navigation Accuracy	3D Positional Accuracy: < 2.0 mm (mean positional error)
	3D Trajectory Accuracy: < 2 degrees (mean trajectory error)
	Max Positional/Displacement Error: 2.80 mm
	Max Trajectory/Angular Error: 3.00°
Virtual Screw Library Verification	Virtual screws accurately represent real screws (length, diameter) and are accurately positioned at the tip of the tracked tool.
Headset Display Performance	Field of View (FOV), resolution, luminance, transmittance, distortion, contrast ratio, temporal, display noise, motion-to-photon latency meet requirements.
Projection Latency	Time delay between instrument movement and display in AR headset < 250 ms.

Electromagnetic Compatibility (EMC)	Compliance with IEC 60601-1-2:2014+A1:2020
Wireless Coexistence	Compliance with AAMI TIR69: 2017/(R)2020 and ANSI IEEE C63.27-2017
Software Verification and Validation	Software meets its requirements specifications.
Human Factors and Usability Validation	Intended users can safely and effectively perform tasks for intended uses in expected use environments.

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

Test Set Sample Size: The document does not explicitly state the sample size (e.g., number of cases or subjects) used for the navigation accuracy testing. It mentions "a spine model" implying a physical phantom rather than patient data.
Data Provenance: The data appears to be from retrospective (bench/phantom) testing using a "spine model" in a controlled environment, not patient data. The country of origin of the data is not specified, but the manufacturer is based in Ohio, USA.

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

The document does not detail the number or qualifications of experts for establishing ground truth for the test set. For the navigation accuracy, "post-surgical CT scan" was used, which is objective data. For human factors, "users" provided feedback; their specific qualifications beyond being "intended users" are not detailed.

4. Adjudication Method for the Test Set

No explicit adjudication method (e.g., 2+1, 3+1) is mentioned. For objective metrics like navigation accuracy (measured from CT), adjudication by experts might not be applicable in the same way as for subjective image interpretation. For human factors, it mentions "users providing feedback," implying a qualitative assessment that might not require formal adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

The document does not describe an MRMC comparative effectiveness study involving human readers and AI assistance. The study focuses on the device's standalone performance and its impact on the accuracy of a connected navigation system (Medtronic StealthStation S8). The device is an augmented reality visualization tool, not an AI diagnostic tool designed to directly improve human reader accuracy in image interpretation.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, the navigation accuracy testing can be considered a form of standalone performance evaluation for the SpineAR SNAP's ability to maintain the accuracy of the connected navigation system. The data presented (mean positional/displacement error, mean trajectory/angular error, projection latency, etc.) reflects the algorithm's performance in conjunction with the navigation system on a physical model, without directly involving human interpretation or decision-making as the primary endpoint. The device itself is software-based and augments visualization rather than providing automated diagnosis.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For Navigation Accuracy: "post-surgical CT scan" of the spine model was used to assess the final placement of screws compared to the pre-surgical plan. This is an objective, image-based ground truth.
For Virtual Screw Library Verification, Headset Display Performance, Projection Latency, EMC, and Wireless Coexistence: The ground truth typically comes from engineering specifications, established measurement techniques, and industry standards. This is generally quantitative/technical ground truth.
For Software Verification and Validation and Human Factors and Usability Validation: The ground truth is established by design requirements and user feedback/observational assessment against defined usability goals.

8. The Sample Size for the Training Set

The document does not provide any information about a training set size. This device appears to be primarily an augmented reality visualization and planning tool that integrates with existing navigation systems, rather than a machine learning model that requires a large training dataset.

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

Since no training set is mentioned (implying the device is not an AI model requiring a training phase), this question is not applicable based on the provided text.

Summary

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September 29, 2022

Surgical Theater, Inc. Kevin Murrock Sr. Director of Quality and Regulatory 30559 Pinetree Road. Suite 206 Pepper Pike. Ohio 44124

Re: K213034

Trade/Device Name: SpineAR SNAP Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO, LLZ Dated: August 26, 2022 Received: August 30, 2022

Dear Kevin Murrock:

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

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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 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,

Shumava 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) K213034

Device Name SpineAR SNAP

Indications for Use (Describe)

The virtual 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)
X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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SpineAR SNAP

510(k) SUMMARY

This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR 8807.92.

Date Prepared: 27-Sep-2022

Manufacturer/Submitter:

Surgical Theater, Inc. 30559 Pinetree Road, Suite 206 Pepper Pike, Ohio 44124 Phone: (216) 496-7884 Fax: (216) 916-3806

Establishment Registration Number: 3010197287

Contact Person:

Kevin M. Murrock Sr. Director of Quality and Regulatory Surgical Theater, Inc. 30559 Pinetree Road, Suite 206 Pepper Pike, Ohio 44124 Phone: (330) 472-6520 Email: kmurrock@surgicaltheater.com

Name of Device

Trade Name: SpineAR SNAP ● Common Name: Augmented Reality System Classification Name: Orthopedic Stereotaxic Instrument ●
Regulation Number: 21 CFR 882.4560 ●
Product Code: OLO
Regulatory Classification: ● II
Device Panel: Orthopedic

Predicate Device

Device Name: StealthStation™ S8 Spine Software v1.3.0 Manufacturer: Medtronic Navigation, Inc. 510(k) Number: K201189

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SpineAR SNAP

Reference Device

Device Name: Surgical Navigation Advanced Platform (SNAP) Manufacturer: Surgical Theater, Inc. 510(k) Number: K160584

Indications for Use:

SpineAR SNAP is intended for use for pre-operative surgical planning on-screen and in a virtual environment, and intra-operative surgical planning and visualization on-screen and in an augmented environment using the HoloLens2 and Magic Leap 1 AR headset displays with validated navigation systems as identified in the device labeling.

The virtual 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:

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Image /page/5/Picture/0 description: The image shows the logo for Surgical Theater. The logo consists of a stylized letter "S" in red and orange gradient, followed by the words "SURGICAL" in red and "THEATER" in yellow. A registered trademark symbol is next to the word "THEATER". There are two black lines underneath the text.

Summary of Technological Characteristics

The SpineAR SNAP is similar in its technological features to its predicate device, the StealthStation S8 Spine Software v1.3.0 (K201189). Both systems are indicated for spinal stereotaxic surgery, and where reference to a rigid anatomical structure, such as the spine, can be identified relative to images of the anatomy.

The SpineAR SNAP does not include any of the physical stereotaxic instrumentation, including camera system, and relies on the positional information supplied by the connected navigation system (e.g. Medtronic StealthStation S8 system with StealthStation Spine Software v1.3.0) to track the position of the surgical instruments relative to the surgical anatomy.

The SpineAR SNAP includes an AR headset that displays the 2D images and 3D scene including navigation and enhanced guidance information in an AR wireless headset (e.g. Microsoft HoloLens2) worn by the surgeon. The predicate device displays 2D and 3D images including navigation information with minimal guidance on a system monitor, and does not support use of AR headset.

Feature	Subject Device:	Predicate Device:	Reference Device:
	SpineAR SNAP	StealthStation S8 SpineSoftware v1.3.0	Surgical NavigationAdvanced Platform (SNAP)
Indications for Use	SpineAR SNAP is intendedfor use for pre-operativesurgical planning on-screenand in a virtual environment,and intra-operative surgicalplanning and visualizationon-screen and in anaugmented environmentusing the HoloLens2 andMagic Leap 1 AR headsetdisplays with validatednavigation systems asidentified in the devicelabeling.SpineAR SNAP is indicatedfor spinal stereotaxicsurgery, and where referenceto a rigid anatomicalstructure, such as the spine,can be identified relative toimages of the anatomy.SpineAR is intended for usein spinal implant procedures,such as Pedicle Screw	The StealthStation™ System,with StealthStation™ SpineSoftware, is intended as an aidfor precisely locatinganatomical structures in eitheropen or percutaneousneurosurgical and orthopedicprocedures. Their use isindicated for any medicalcondition in which the use ofstereotaxic surgery may beappropriate, and wherereference to a rigid anatomicalstructure, such as the spine orpelvis, can be identifiedrelative to images of theanatomy.This can include the followingspinal implant procedures,such as:o Pedicle Screw Placemento Iliosacral Screw Placemento Interbody Device Placement	The SNAP is intended for useas a software interface andimage segmentation systemfor the transfer of imaginginformation from a medicalscanner such as a CT or MRscanner to an output file.It is also intended for use insimulating and evaluatingsurgical treatment options bothpre-operatively and intra-operatively with validatedsystems as identified in thedevice labeling.
Feature	Subject Device:SpineAR SNAP	Predicate Device:StealthStation S8 SpineSoftware v1.3.0	Reference Device:Surgical NavigationAdvanced Platform (SNAP)
	Placement, in the lumbar andthoracic regions with theMagic Leap 1 AR headset,and in the lumbar regionwith the HoloLens2 ARheadset.The virtual display shouldnot be relied upon solely forabsolute positionalinformation and shouldalways be used inconjunction with thedisplayed 2D stereotaxicinformation.
Main systemcomponents	Cart with computer,touchscreen monitor,UPS and input devices. Software application AR Headset VR Headset	Platform including cart,computer, monitor andtracking cameras Software application Reflective markers -Spheres Accessories (Instrumentadaptors, referencingsystem)	Cart with computer,touchscreen monitor andinput devices. Software application VR Headset
System AccuracyRequirements	Provided by the connected3rd party navigation systemas the subject device does notinclude a camera system ortracking arrays.Maintains the systemaccuracy of the connectednavigation system.3D positional accuracy witha mean positional error of$\le$ 2.0 mm and meantrajectory error of $\le$ 2degrees.	Under representative worst-case Configuration, theStealthStation S8 Spinesoftware v1.3.0, hasdemonstrated performance in3D positional accuracy with amean positional error of $\le$ 2.0mm and mean trajectory errorof $\le$ 2 degrees.Mean Accuracy Values(StealthAiR Spine):Positional Error - 1.01 mmTrajectory Error - 0.37degreesMean Accuracy Values(Overlapping Slices):Positional Error - 0.51 mmTrajectory Error -0.41degrees	Provided by the connected 3rdparty navigation system as thesubject device does notinclude a camera system ortracking arrays.
Imaging Modalities	CT, MR and XA	X-Ray Based Imaging	CT, MR and XA
Registration Features	All registration is performedby the connected 3rd partynavigation system.	PointMerge Registration SurfaceMergeRegistration	All registration is performedby the connected 3rd partynavigation system.
Feature	Subject Device:SpineAR SNAP	Predicate Device:StealthStation S8 SpineSoftware v1.3.0	Reference Device:Surgical NavigationAdvanced Platform (SNAP)
Planning Features	Plan Entry and TargetSelection 3D Model Building Directional Markers	Plan Entry and TargetSelection 3D Model Building Deformity Planning	Plan Entry and TargetSelection 3D Model Building
Medical DeviceInterfaces	The system does not interfacedirectly with the imagingmodality device.	O-arm Imaging System Ziehm Vision FD Vario3D C-Arm ISO-C 3D C-Arm Ziehm Vision RFD 3D C-arm Stealth-Midas MR8 Orbic 3D C-Arm	The system does not interfacedirectly with the imagingmodality device.
LocalizationTechnology	The subject device does notinclude a camera system ortracking arrays, but insteadrelies on the stereotaxicguidance provided from aconnected 3rd partynavigation system to trackpatient anatomy and surgicaltools.	Optical (infra-red)	The subject device does notinclude a camera system ortracking arrays, but insteadrelies on the stereotaxicguidance provided from aconnected 3rd party navigationsystem to track patientanatomy and surgical tools.
Connection to 3rdparty surgicalnavigation system totrack patient anatomyand surgical tools.	Yes. MedtronicStealthStation S8 SpineSoftware v1.3.0	No	Medtronic StealthStation S8Cranial Version 1.3.0-49 andBrainlab Cranial Version 2.1
Capability of creating3D models of patientdata from 2D scanslices.	Yes	Yes	Yes
Virtual Reality (VR)Headset Display forPre-Operative Use	Yes	No	Yes
Augmented Reality(AR) HeadsetDisplay for Intra-operative Use	Yes	No	No
Intra-operativevisualization andguidance tools shownon a wireless ARheadset display.	Yes	No	No
Feature	Subject Device:SpineAR SNAP	Predicate Device:StealthStation S8 SpineSoftware v1.3.0	Reference Device:Surgical NavigationAdvanced Platform (SNAP)
Visual GuidanceOptions with color-coded cues.	1) Dotted Line2) Orientation Line3) ILS	No	No

The following table compares the key features of the subject and predicate devices:

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SpineAR SNAP

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SpineAR SNAP

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The differences between the subject and predicate device do not raise any new questions regarding safety and effectiveness. Based on the information provided in this 510(k) submission. the SpineAR SNAP is considered substantially equivalent to the predicate device in terms of fundamental scientific technology.

Performance Data

The following non-clinical performance testing was conducted to evaluate the subject device to ensure the SpineAR SNAP meets its intended use and performance requirements.

Software Verification and Validation was performed to test the software requirements specifications for the SpineAR SNAP.
Human Factors and Usability Validation demonstrated that the intended users of a SpineAR SNAP can safely and effectively perform tasks for the intended uses in the expected use environments, i.e. intraoperative use of the AR headsets. Validation took place under conditions of simulated use with users providing feedback on the usability of the software for performing defined tasks.
Navigation Accuracy testing was conducted to demonstrate that SpineAR does not negatively affect the navigation accuracy of the connected Medtronic StealthStation 8 surgical navigation system. The final placement of each screw in a spine model was assessed via a post-surgical CT scan and compared to the pre-surgical plan to calculate the absolute displacement of the screw tip and absolute angular error of the screw. The summary of accuracy test results below demonstrate performance in 3D positional and trajectory accuracy that is within the system accuracy of the StealthStation S8 (mean positional error < 2.0 mm and mean trajectory error of < 2°):
- Mean Positional/Displacement Error: 1.02 mm O
- Max Positional/Displacement Error: 2.80 mm O
- Mean Trajectory/Angular Error: 1.79° O
- o Max Trajectory/Angular Error: 3.00°
Verification of virtual screw library by verifying the length and diameter (e.g. 40 mm x 5.5 mm) of virtual screws shown in the 3D model accurately represent the real screws used during surgery, and screws are accurately positioned at the tip of the tracked tool.
Performance of the Headset display was demonstrated by verifying the following elements: Field of View (FOV), resolution, luminance, transmittance, distortion, contrast ratio, temporal, display noise and motion-to-photon latency.

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Image /page/9/Picture/0 description: The image shows the logo for Surgical Theater. The logo consists of a stylized letter "S" in orange and yellow gradient, followed by the words "SURGICAL" in red and "THEATER" in yellow. The words are stacked on top of each other, with "SURGICAL" on top and "THEATER" on the bottom. There is a trademark symbol next to the word "THEATER".

Projection latency testing was performed to assess the time delay between movement of a navigated handheld instrument and its display in the scene shown in the Magic Leap 1 and Microsoft HoloLens2 AR headsets. Based on experience with other types of simulators and feedback from surgeons during usability testing, a time delay requirement of < 250 ms was established. The summary of latency test results below demonstrates the projection delay for both AR headsets is acceptable:
- o Average Delay: 195 ms for HoloLens2 and 195 ms for Magic Leap 1
- o Worst Case Delay: 231 ms for HoloLens2 and 231 ms for Magic Leap 1
Electromagnetic Compatibility (EMC) was tested in accordance with IEC 60601-1-● 2:2014+A1:2020 for all system components including both the Magic Leap 1 and Microsoft HoloLens2 AR headsets.
Wireless coexistence was evaluated and tested per AAMI TIR69: 2017/(R)2020 and ANSI IEEE C63.27-2017.

Performance data demonstrated the SpineAR SNAP functions as intended without raising new safety or effectiveness issues, and does not impact accuracy or clinical workflow. The test results support a finding that the SpineAR SNAP is substantially equivalent to the predicate StealthStation S8 Spine Software v1.3.0.

Substantial Equivalence Conclusion

The SpineAR SNAP is substantially equivalent to the StealthStation™ S8 Spine Software v1.3.0. The SpineAR SNAP has the same intended use and similar indications, technological characteristics, and principles of operation as the predicate device. Any differences between the subject and predicate device do not raise any new concerns regarding safety and effectiveness.

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).