SpineAR SNAP is intended for use for 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 and HoloLens2 AR headsets.

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 surgeon's view of the surgical space.

AI/ML Overview

The provided text describes the acceptance criteria and the study conducted to prove that the SpineAR SNAP device meets these criteria, specifically addressing the expansion of its indications for use with the HoloLens2 AR headset to include the thoracic region in addition to the lumbar region.

Here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

The acceptance criteria are presented as "Accuracy Requirement" in the table, and the "HoloLens2 AR Headset Results" are the reported device performance for the subject device.

Metric	Acceptance Criteria	Reported Device Performance (HoloLens2 AR Headset Results)
Mean Positional/Displacement Error	≤ 2.0 mm	0.76 mm
Max Positional/Displacement Error	≤ 3.0 mm	1.47 mm
Mean Trajectory/Angular Error	≤ 2°	1.73°
Max Trajectory/Angular Error	≤ 3°	2.96°

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the exact sample size (number of screws or spine models) used for the test set. It only mentions that the final placement of "each screw in a spine model" was assessed.

The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. However, the study describes a controlled performance test involving a "spine model," suggesting a prospective, in-vitro (non-human) study designed to evaluate accuracy.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

The document does not specify the involvement of human experts for establishing the ground truth of the pedicle screw placement in this particular performance study. The ground truth appears to be established through "post-surgical CT scan" data compared to a "pre-surgical plan."

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

No adjudication method involving human experts is described for this performance study. The assessment of screw placement was based on quantifiable measurements derived from CT scans.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This study focuses on the device's accuracy in a non-human, simulated environment (spine model) and compares the HoloLens2 performance to the previously cleared Magic Leap 1. It does not evaluate human reader performance or the improvement with AI assistance.

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

This study is essentially a standalone (algorithm only) performance assessment, although the device (SpineAR SNAP) is an augmented reality system intended for human use. The performance test specifically evaluates the accuracy of the system's guidance during simulated pedicle screw placement, independent of the surgeon's skill. The "human-in-the-loop" aspect during clinical use is acknowledged, but the performance testing here isolates the device's accuracy in a controlled setup.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth used was objective quantitative measurements derived from post-surgical CT scans of a spine model, which were then compared against the pre-surgical plan. This is a form of objective physical ground truth.

8. The sample size for the training set

The document does not provide any information about the training set size or methodology. This submission is for a modification to an existing device (expanding indications for an existing AR headset), not the initial development or de novo clearance of the core algorithm.

9. How the ground truth for the training set was established

As no information on a training set is provided, how its ground truth was established is also not detailed. The current study focuses on validation of expanded indications through performance testing only.

Summary

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December 24, 2024

Surgical Theater, Inc. Kevin Murrock Sr. Director of Quality & Regulatory 23645 Mercantile Road Suite M Beachwood, Ohio 44122

Re: K243623

Trade/Device Name: SpineAR SNAP (SyncAR Spine) Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: SBF, LLZ Dated: November 21, 2024 Received: November 25, 2024

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 (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about 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

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by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Shumaya Ali -S

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) K243623

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

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510(k) Premarket Notification

510(k) SUMMARY

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

Date Prepared: 23-Dec-2024

510(k) Type: Special 510(k) for Device Modification

Manufacturer/Submitter:

Surgical Theater, Inc. 23645 Mercantile Road, Suite M Beachwood, Ohio 44122 Phone: (330) 472-6520

Establishment Registration Number: 3010197287

Contact Person:

Kevin M. Murrock Sr. Director of Quality and Regulatory 23645 Mercantile Road, Suite M Beachwood, Ohio 44122 Phone: (330) 472-6520 Email: kmurrock@surgicaltheater.com

Name of Device

Trade Name: SpineAR SNAP ●
Other Device Trade Names:
Common Name: ●
Classification Name:
Regulation Number:
Product Code:
Regulatory Classification: ●
Device Panel: ●

SyncAR Spine Augmented Reality System Orthopedic Stereotaxic Instrument 21 CFR 882.4560 SBF, LLZ II Orthopedic

Predicate Device

Device Name: SpineAR SNAP Manufacturer: Surgical Theater, Inc. 510(k) Number: K213034

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SpineAR SNAP

Device Description:

Intended Use / 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.

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Summary of Technological Characteristics

The modified SpineAR SNAP has identical technological characteristics, principle of operation, and intended use of the predicate device. No design changes are included in the device modification for this 510(k) submission as only non-clinical performance testing was necessary to support the expanded indications for use of the SpineAR SNAP with the HoloLens2 AR headset from spinal implant procedures in lumbar region only to also include spinal implant procedures in thoracic region.

The following table is a comparison of the technological characteristics of the subject and predicate devices included in the scope of this 510(k).

Feature	Predicate Device:SpineAR SNAP	Subject Device:SpineAR SNAP
Manufacturer	Surgical Theater, Inc.	Surgical Theater, Inc.
Indications for Use	SpineAR SNAP is intended for usefor pre-operative surgical planningon-screen and in a virtualenvironment, and intra-operativesurgical planning and visualizationon-screen and in an augmentedenvironment using the HoloLens2and Magic Leap 1 AR headsetdisplays with validated navigationsystems as identified in the devicelabeling.SpineAR SNAP is indicated forspinal stereotaxic surgery, andwhere reference to a rigidanatomical structure, such as thespine, can be identified relative toimages of the anatomy. SpineARis intended for use in spinalimplant procedures, such asPedicle Screw Placement, in thelumbar and thoracic regions withthe Magic Leap 1 AR headset, andin the lumbar region with theHoloLens2 AR headset.The virtual display should not berelied upon solely for absolutepositional information and shouldalways be used in conjunction with	SpineAR SNAP is intended for usefor pre-operative surgical planningon-screen and in a virtualenvironment, and intra-operativesurgical planning and visualizationon-screen and in an augmentedenvironment using the HoloLens2and Magic Leap 1 AR headsetdisplays with validated navigationsystems as identified in the devicelabeling.SpineAR SNAP is indicated forspinal stereotaxic surgery, andwhere reference to a rigidanatomical structure, such as thespine, can be identified relative toimages of the anatomy. SpineAR isintended for use in spinal implantprocedures, such as Pedicle ScrewPlacement, in the lumbar andthoracic regions with the MagicLeap 1 and HoloLens2 AR headsets.The virtual display should not berelied upon solely for absolutepositional information and shouldalways be used in conjunction withthe displayed 2D stereotaxicinformation.

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510(k) Premarket Notification

Feature	Predicate Device:SpineAR SNAP	Subject Device:SpineAR SNAP
	the displayed 2D stereotaxic information.
Magic Leap 1 Intra-operative Indications for Use	Spinal implant procedures, such asPedicle Screw Placement, in boththe lumbar and thoracic regions.	Spinal implant procedures, such asPedicle Screw Placement, in both thelumbar and thoracic regions.
HoloLens2 Intra-operative Indications for Use	Spinal implant procedures, such asPedicle Screw Placement, in thelumbar region only .	Spinal implant procedures, such asPedicle Screw Placement, in both thelumbar and thoracic regions.

Performance Data

Performance testing was conducted to demonstrate the SpineAR with HoloLens2 AR headset is substantially equivalent to the use of the Magic Leap 1 AR headset cleared in the predicate SpineAR SNAP when performing spinal implant procedures in the thoracic region. 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 and absolute angular error of the screw. The HoloLens2 navigation accuracy test results in Table 1 demonstrate performance in 3D positional and trajectory accuracy that meets the accuracy of the predicate SpineAR SNAP using the Magic Leap 1 AR headset.

	AccuracyRequirement	Magic Leap 1 ARHeadset Results	HoloLens2 ARHeadset Results
Mean Positional/Displacement Error	$\leq$ 2.0 mm	1.04 mm	0.76 mm
Max Positional/Displacement Error	$\leq$ 3.0 mm	1.90 mm	1.47 mm
Mean Trajectory/Angular Error	$\leq$ 2°	1.92°	1.73°
Max Trajectory/Angular Error	$\leq$ 3°	2.80°	2.96°

Table 1 - Performance Test Results: Accuracy of Pedicle Screw Placement in Thoracic Region

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 use of the HoloLens2 AR headset in the subject device is substantially equivalent to the use of the Magic Leap 1 AR headset in the predicate SpineAR SNAP when performing spinal implant procedures in the thoracic region.

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510(k) Premarket Notification

Substantial Equivalence Conclusion

The SpineAR SNAP is substantially equivalent to its predicate. Both the subject and predicate devices have identical intended use, technological characteristics, and principles of operation. The indications for use are similar with the only difference being the expanded use of the HoloLens2 AR headset for spinal implant procedures in the thoracic region. Previously the use of the HoloLens2 was only indicated for spinal implant procedures in the lumbar region, while the Magic Leap 1 AR headset was indicated for use in both the lumbar and thoracic regions. The modified indications for use did not require any design change, only the acquisition of additional performance data supporting the use of the HoloLens2 with SpineAR for spinal implant procedures in the thoracic region.

Any differences between the subject and predicate device do not raise any new concerns regarding safety and effectiveness, and performance testing demonstrates that the subject device is at least as safe and effective as the predicate device, and functions as intended.

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).