The xvision Spine System, with xvision 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 or pelvis, can be identified relative to a patient's fluoroscopic or CT imagery of the anatomy. This can include the following spinal procedures:

Posterior Pedicle Screw Placement in the thoracic and sacro-lumbar region.
Posterior Screw Placement in C3-C7 vertebrae
Iliosacral Screw Placement
Angular procedures requiring access to the disc space
Lateral trajectories required to access the Sacro-Iliac joint

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 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 used in conjunction with the displayed stereotaxic information.

Device Description

The xvision Spine (XVS) system is an image-guided navigation system that is designed to assist surgeons in placing pedicle screws accurately, during open or percutaneous computer-assisted spinal surgery. The system consists of dedicated software, Headset, single use passive reflective markers and reusable components. It uses wireless optical tracking technology and displays to the surgeon the location of the tracked surgical instruments relative to the acquired patient's scan, onto the surgical field. The 2D scanned data and 3D reconstructed model, along with tracking information, are projected to the surgeons' retina using a transparent near-eye-display Headset, allowing the surgeon to both look at the patient and the navigation data at the same time.

This special 510(k) submission outlines minor software modifications to the cleared XVS system, aimed at enhancing the 2D-3D registration process. Changes include minor updates to the C-ARM Ring adaptor, XVS sterile kits with C- and X-markers, and the addition of a patient marker extender for improved reflectors' visibility. A new software version introduces enhancements to the GUI, ease of use, and bug fixes.

AI/ML Overview

The provided text is a 510(k) summary for the Augmedics xvision Spine system, a medical device with minor modifications. This type of submission focuses on demonstrating substantial equivalence to a previously cleared device, not a de novo clearance that would typically involve extensive clinical trials to establish new performance criteria. Therefore, the information provided primarily addresses hardware and software modifications and their impact on existing performance, rather than defining and proving novel acceptance criteria for a new device.

Based on the provided text, here's an analysis of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of acceptance criteria for specific performance metrics of the AI/software component, as it's a minor modification submission. However, it explicitly states:

Acceptance Criteria Mentioned:
- "System Level Accuracy with a mean 3D positional error of 2.0mm and mean trajectory error of 2°" (This is an identical characteristic to the predicate device and is stated as a requirement for both).
- Performance tests verified that mechanical stability of the attachment of the new component, overall system accuracy and compliance with existing sterilization, cleaning and transportation standards is maintained.
Reported Device Performance (for the modified system):
- "Performance tests verified that mechanical stability of the attachment of the new component... is maintained."
- "the overall system accuracy, including positional and angular accuracy during 2D/3D registration, was validated successfully using the same methods and acceptance criteria [as the predicate device]."
- "Performance data (bench), demonstrate that the modified parts meet the same acceptance criteria as the cleared parts and that the accuracy performance of the modified XVS system is comparable to the accuracy results of the predicate device."

Summary Table (Derived from the text):

Acceptance Criteria (from Predicate Device)	Reported Device Performance (Modified Device)
System Level Accuracy: mean 3D positional error of 2.0mm	Overall system accuracy, including positional accuracy during 2D/3D registration, validated successfully using the same methods and acceptance criteria as the predicate. Performance data (bench) demonstrate accuracy is comparable to the predicate device.
System Level Accuracy: mean trajectory error of 2°	Overall system accuracy, including angular accuracy during 2D/3D registration, validated successfully using the same methods and acceptance criteria as the predicate. Performance data (bench) demonstrate accuracy is comparable to the predicate device.
Mechanical stability of new components (Patient Marker Extender)	Performance testing demonstrated that the mechanical stability of the Patient Marker Extender assembly meets the same acceptance criteria as the cleared Patient Marker assembly (K241481).
Compliance with existing sterilization, cleaning, and transportation standards	Performance tests verified compliance with existing sterilization, cleaning, and transportation standards.
Software Functionality, GUI, cybersecurity, HIPAA enhancements	Software changes were validated per FDA guidance and Augmedics' Software Lifecycle Procedure, ensuring the software operates as intended. This includes support for the new component, GUI enhancements for a more intuitive 2D-3D registration process, and cybersecurity and HIPAA enhancements.

2. Sample size used for the test set and the data provenance

The document states, "Performance data (bench)", indicating the tests were conducted in a laboratory or simulated environment rather than with patient data. It does not provide specific sample sizes (e.g., number of models, number of trials) for these bench tests. The provenance is implied to be from Augmedics' internal testing in Israel (based on the submitter's address), and the data are likely prospective in nature as they concern verifying changes to a device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided. Since the performance evaluations appear to be bench tests against engineering specifications (e.g., positional and angular accuracy), it's unlikely that clinical expert ground truth was established for this specific submission. The ground truth for the core device's accuracy would have been established during the original clearance (K241481), but details are not included here for this modification.

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

Not applicable based on the information provided. The evaluations are described as "bench tests" and "performance data (bench)", implying quantitative measurements against engineering tolerances rather than subjective assessments requiring 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

No such study was mentioned. The device is an image-guided navigation system for surgery, not an AI diagnostic tool that assists human readers/interpreters in a diagnostic task. The AI component mentioned is for "Deep-Learning Based Spine Segmentation Algorithms," which aids in preparing the surgical navigation data, not interpreting images for diagnosis. The modifications relate to hardware components and software enhancements for workflow and reliability, not changes to the core AI segmentation algorithms requiring a new MRMC study.

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

The document mentions "Deep-Learning Based Spine Segmentation Algorithms" as an identical characteristic to the predicate. It also states "the overall system accuracy, including positional and angular accuracy during 2D/3D registration, was validated successfully using the same methods and acceptance criteria." While this suggests evaluation of the system's accuracy (which would include the algorithm's contribution), it doesn't describe a standalone algorithm-only performance study in isolation from the full system's operation, nor does it provide detailed metrics for such a study. The focus is on the integrated system's performance.

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

For the accuracy components, the ground truth would have been derived from precise physical measurements and calibrations in a controlled bench test environment (e.g., using CMM - Coordinate Measuring Machine, as mentioned, or other metrology tools) against known true values. For the segmentation algorithms, the ground truth for training and evaluation would typically be meticulously annotated anatomical structures, likely by medical experts. However, these details are not provided for this submission, as the segmentation algorithms themselves are identified as identical to the predicate.

8. The sample size for the training set

This information is not provided. The deep learning segmentation algorithms are noted as identical to the predicate device, meaning their training would have occurred prior to the predicate's clearance (K241481).

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

This information is not provided. As with point 8, this process would have occurred for the predicate device. Typically, for deep learning segmentation in medical imaging, ground truth is established through manual annotation by qualified medical professionals (e.g., radiologists, anatomists, surgeons) following specific guidelines.

Summary

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March 13, 2025

Augmedics Ltd. % Janice M. Hogan Partner Hogan Lovells US LLP 1735 Market Street, Floor 23 Philadelphia, Pennsylvania 19103

Re: K250255

Trade/Device Name: xvision Spine system Regulation Number: 21 CFR 882.4560 Regulation Name: Orthopedic Augmented Reality Regulatory Class: Class II Product Code: SBF Dated: January 28, 2025 Received: March 13, 2025

Dear Janice M. Hogan:

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) K250255

Device Name xvision Spine System

Indications for Use (Describe)

The xvision Spine System, with xvision System Software, is intended as an aid for precisely locating anatomical structures in either open or percutaneous spine procedures.

Posterior Pedicle Screw Placement in the thoracic and sacro-lumbar region.
Posterior Screw Placement in C3-C7 vertebrae
Iliosacral Screw Placement
Angular procedures requiring access to the disc space
Lateral trajectories required to access the Sacro-Iliac joint

The virtual display should not be relied upon solely for absolute positional information and should always be used in conjunction with the displayed 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) Summary Augmedics'

xvision Spine system

SUBMITTER

Augmedics LTD. 2 Ha-Otsma St. Yokneam Illit, 2069205, Israel Phone: +972-4-3730111 Contact person: Tami Harel Date prepared: January 28, 2025 Name of device: xvision Spine System

Common or Usual Name:	XVS
Classification Name:	Orthopedic Augmented Reality (21 CFR 882.4560)
Regulatory Class:	Class II
Product Code:	SBF
Predicate Device:	xvision Spine System, manufactured byAugmedics Ltd. Israel (K241481)

INTENDED USE / INDICATIONS FOR USE

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.

Posterior Pedicle Screw Placement in the thoracic and sacro-lumbar region.
-Posterior Screw Placement in C3-C7 vertebrae
Iliosacral Screw Placement -
-Anqular procedures requiring access to the disc space
Lateral trajectories required to access the Sacro-Iliac joint -

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 trainct.

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The virtual display should not be relied upon solely for absolute positional information and should always be used in conjunction with the displayed stereotaxic information.

DEVICE DESCRIPTION

SUMMARY OF TECHNOLOGICAL CHARACTERISTICS

The technological characteristics of the modified XVS system are identical to the technological characteristics of the predicate device. Both the cleared and the subject devices optical tracking technology and display, to the surgeon, the tracked surgical instruments relative to the acquired patient's scan, onto the surgical field. The 2D scanned data and 3D reconstructed model, along with tracking information, are projected to the surgeons' retina using a transparent near-eye-display headset, allowing the surgeon to both look at the patient and the navigation data at the same time.

This submission outlines a series of minor hardware and software modifications aimed at enhancing the 2D-3D registration workflow, improving component reliability, and adding transportation package option for XVS sterile kits. To enhance the registration process, hardware changes were applied to the C-ARM Ring Adapter and a new component (i.e., Patient Marker Extender) was introduced. Software modifications include cybersecurity and HIPPA enhancement, adding GUI guidance and enforce allowable distances and angles for markers during registration. Reliability of components has been improved through minor deign changes. Lastly, a new transportation package for XVS sterile kits holding 3-unit package, was introduced to complement the existing 10-unit package. Performance tests verified that mechanical stability of the attachment of the new component, overall system accuracy and compliance with existing sterilization, cleaning and transportation standards is maintained.

The minor hardware and software changes do not impact clinical use, and do not raise any new questions of safety or efficacy. Together these modifications enhance ease of use and reliability while preserving the device's fundamental technology, safety, and effectiveness.

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To conclude, while the modified XVS system offers minor enhancements to some hardware components and some software features, the basic technology remains the same and is validated using the same method and the same success criteria.

A substantial equivalence table summarizing the similarities and differences between the xvision Spine system and its predicate device is provided below.

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Augmedics Ltd.

xvision Spine system Substantial Equivalence Comparison Table

	xvision Spine(subject device)	xvision Spine(K241481)	Conclusion
Intended Use	The xvision Spine System, with xvision Spine SystemSoftware, is intended as an aidfor precisely locatinganatomical structures in eitheropen or percutaneous spineprocedures	The xvision Spine System, with xvision Spine SystemSoftware, is intended as an aidfor precisely locatinganatomical structures in eitheropen or percutaneous spineprocedures	Identical
Indications forUse	Their use is indicated for anymedical condition in which theuse of stereotactic surgerymay be appropriate, andwhere reference to a rigidanatomical structure, such asthe spine or pelvis, can beidentified relative to a patient'sfluoroscopic or CT imagery ofthe anatomy. This can includethe following spinalprocedures:- Posterior Pedicle ScrewPlacement in the thoracicand sacro-lumbar region.- Posterior Screw Placementin C3-C7 vertebrae- Iliosacral Screw Placement- Angular proceduresrequiring access to the discspace- Lateral trajectories requiredto access the Sacro-Iliacjoint	Their use is indicated for anymedical condition in which theuse of stereotactic surgerymay be appropriate, andwhere reference to a rigidanatomical structure, such asthe spine or pelvis, can beidentified relative to a patient'sfluoroscopic or CT imagery ofthe anatomy. This can includethe following spinalprocedures:- Posterior Pedicle ScrewPlacement in the thoracicand sacro-lumbar region.- Posterior Screw Placementin C3-C7 vertebrae- Iliosacral Screw Placement- Angular proceduresrequiring access to the discspace- Lateral trajectories requiredto access the Sacro-Iliacjoint	Identical
User Population	Orthopedic surgeons orneurosurgeons	Orthopedic surgeons orneurosurgeons	Identical
Intended UseEnvironment	Operating Room	Operating Room	Identical
Main SystemComponents	- Headset with near eye see-through display and trackingcamera.- Software application- Flat reflective markers	- Headset with near eye see-through display and trackingcamera.- Software application- Flat reflective markers	Identical
	xvision Spine(subject device)	xvision Spine(K241481)	Conclusion
	Tool adaptors Reference point: Patient Clamp and Perc Pin Computer, roll stand or Cart C-ARM Ring Adapter	Tool adaptors Reference point: Patient Clamp and Perc Pin Computer, roll stand or Cart C-ARM Ring Adapter
RegistrationMethods	IntraOp - requiring IntraOp 3D scan (Z-link & X-link) 2D-3D (PreOp), requiring PreOp 3D CT scan and at least two IntraOp X-ray images	IntraOp - requiring IntraOp 3D scan (Z-link & X-link) 2D-3D (PreOp), requiring PreOp 3D CT scan and at least two IntraOp X-ray images	Identical
Rigid ReferencePoint	Patient Clamp attached to the spinous process Perc Pin inserted into the PSIS A Patient Marker can be directly attached to the Patient Clamp or the Perc Pin.Alternatively, a Patient Marker Extender can be attached to the Patient Clamp or the Perc Pin, providing an interface for securing the Patient Marker.	Patient Clamp attached to the spinous process Perc Pin inserted into the PSIS A Patient Marker is directly attached to either the Patient Clamp or the Perc Pin	Similar.A new component, the Patient Marker Extender, is introduced in this market application. The Patient Marker Extender extends the Patient Marker to prevent partial coverage of its reflectors by the C-ARM detector during the 2D/3D registration process. However, there is no change in the registration workflow or in the principal technology that supports it. Performance testing demonstrated that the mechanical stability of the Patient Marker Extender assembly meets the same acceptance criteria as the cleared Patient Marker assembly (K241481). Additionally, the overall system accuracy, including positional and angular accuracy during 2D/3D registration, was validated successfully using the same methods and acceptance criteria
	xvision Spine(subject device)	xvision Spine(K241481)	Conclusion
Instrument (Tool) Adaptors	Reusable Universal (connects to various tools, not system-specific) VP & Ergonomic (system specific adaptors)	Reusable Universal (connects to various tools, not system-specific) VP & Ergonomic (system specific adaptors)	Identical
Localization Technology	Optical	Optical	Identical
Reflective Markers	Flat Single use, provided sterile Sterilized by Gamma Radiation	Flat Single use, provided sterile Sterilized by Gamma Radiation	Identical
Optical Tracker	Single infrared camera, positioned 0.5m above tracked objects	Single infrared camera, positioned 0.5m above tracked objects	Identical
Tracking	6 DOF	6 DOF	Identical
Tracking Algorithm	Perspective N-point	Perspective N-point	Identical
System Accuracy Requirement	System Level Accuracy with a mean 3D positional error of 2.0mm and mean trajectory error of 2°	System Level Accuracy with a mean 3D positional error of 2.0mm and mean trajectory error of 2°	Identical
Deep-Learning Based Spine Segmentation Algorithms	Full spine anatomy segmentation from background Segmentation of single spine vertebra	Full spine anatomy segmentation from background Segmentation of single spine vertebra	Identical
Imaging Modality	X-ray based imaging	X-ray based imaging	Identical
Medical Device Interfaces	O-arm Imaging System Ziehm Vision FD Vario 3D C-Arm and RFD 3D Siemens CIOS SPin Airo system by Brainlab ExcelsiusGPS Round C-ARMS: GE OEC 9900 Elite, GE OEC 9800 and 9800 plus all 9" & 12" models	O-arm Imaging System Ziehm Vision FD Vario 3D C-Arm and RFD 3D Siemens CIOS SPin Airo system by Brainlab ExcelsiusGPS Round C-ARMS: GE OEC 9900 Elite, GE OEC 9800 and 9800 plus all 9" & 12" models	Identical
Display Optics and Technology	Augmented Reality using near eye see-through display; data displayed on patient's anatomy	Augmented Reality using near eye see-through display; data displayed on patient's anatomy	Identical
	xvision Spine(subject device)	xvision Spine(K241481)	Conclusion
CommunicationBetween Headsetand Computer	Wireless, encrypted	Wireless, encrypted	Identical
SupportedFrequencies &TransmissionProtocol	5 GHz802.11g/n/ac	5 GHz802.11g/n/ac	Identical
Frame Rate ofDisplayed Images	60 fps	60 fps	Identical
OE Field of View	32.5° (vertical) X 18°(horizontal)	32.5° (vertical) X 18°(horizontal)	Identical
Pixel Resolution	1280x720 per eye	1280x720 per eye	Identical
Optical Distortion	<5%	<5%	Identical
Headset PowerSource	Li-ion rechargeable battery	Li-ion rechargeable battery	Identical
Number ofSupportedHeadsets	Two	Two	Identical

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PERFORMANCE DATA

Minor design modifications were made to the C-ARM Ring adaptor, XVS sterile kits with C- and Xmarkers, and the addition of an extender to the patient marker. These changes aim to improve reliability, enhance workflow, and enable additional kit packaging configurations, without altering the principles of operation or technology.

To assess the impact of the modifications on the device and its components, a Risk Analysis was conducted according to ISO 14971 - Medical Devices - Application of Risk Management to Medical Devices. Verification and validation activities required to comply with 21 CFR 820.30 were determined based on this analysis.

All modifications underwent verification following the same protocols and acceptance criteria as the cleared XVS system (K241481), with additional Form, Fit, and Function (FFF) tests for the modified components. Verification used established methods, including CMM and calculations, demonstrating substantial equivalence.

The XVS software includes minor updates from the cleared version, such as support for the new component, GUI enhancements for a more intuitive 2D-3D registration process, and cybersecurity and HIPAA enhancements. Software changes were validated per FDA guidance and Augmedics' Software Lifecycle Procedure, ensuring the software operates as intended.

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CONCLUSIONS

The modified XVS system and cleared XVS system have the same intended use and indications for use, same technological characteristics and the same principles of operation. The minor design changes that are introduced in the proposed system are aimed at enhancing the parts reliability or facilitating the execution of the cleared workflow. These differences do not present different questions of safety or effectiveness than the predicate device. Performance data (bench), demonstrate that the modified parts meet the same acceptance criteria as the cleared parts and that the accuracy performance of the modified XVS system is comparable to the accuracy results of the predicate device.

Thus, the modified XVS system is substantially equivalent to its predicate device, the cleared XVS system (K241481).

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).