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 CT imagery of the anatomy. This can include the following spinal implant procedures:

Posterior Pedicle Screw Placement in the thoracic and sacro-lumbar region.
Posterior Screw Placement in C3-C7 vertebrae
Iliosacral Screw Placement

The Headset of the xvision 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 a 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 intraoperative 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.

The following modifications have been applied to the previously cleared XVS system:

The indications for use of the subject device are expanded compared to the cleared predicate device and include screw instrumentation in additional spine segments, i.e., cervical C3-C7 vertebrae and iliosacral region. Additionally, an Artificial Intelligence (AI) spine segmentation algorithm, based on Convolutional Neural Network (CNN), has been added to provide an improved virtual 3D spine model. The virtual 3D model can be built from the original CT scan or from the Al segmented CT scan. Neither of these modifications alters the intended use of the device as an aid in localization during spine surgery or its principles of operation.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the xvision Spine System, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides the "System Accuracy Requirement" as the primary acceptance criterion related to performance. The study then reports on validation studies that demonstrate the device meets these specifications.

Acceptance Criterion (System Level Accuracy)	Reported Device Performance
Mean 3D positional error of 2.0 mm	Validated in two cadaver studies. Positional errors calculated as the difference between actual and virtual screw tip position.
Mean trajectory error of 2°	Validated in two cadaver studies. Trajectory errors calculated as the difference between screw orientation and its recorded virtual trajectory.
Additional Performance Parameter (AI Segmentation)	Reported Device Performance
Not explicitly stated as an "acceptance criterion" in a quantitative manner, but performance of the AI segmentation algorithm was validated.	Mean Dice coefficient calculated. Compared to manual segmentations approved by US physicians.
Additional Performance Parameter (Clinical Accuracy)	Reported Device Performance
Not explicitly stated as an "acceptance criterion," but clinical accuracy was evaluated.	Evaluated using the Gertzbein-Robbins score by viewing post-op scans.

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

Test Set Sample Size: Two cadaver studies were conducted. The specific number of cases, screws, or segments tested within these cadaver studies is not explicitly stated in the provided document.
Data Provenance: The document states "two cadaver studies." This suggests the data is prospective (generated for this specific testing) and likely from a laboratory or research setting. The country of origin of the cadavers or the study location is not specified.

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

For the cadaver studies (positional and trajectory errors), the method of establishing ground truth (e.g., through physical measurements) is implied by "actual... screw tip position" and "actual... screw orientation" but the number or qualifications of experts involved in these measurements are not specified.
For the AI segmentation algorithm validation: "manual segmentations that were approved by US physicians" were used as ground truth. The number of physicians/experts and their specific qualifications (e.g., years of experience as radiologists or surgeons) are not specified.

4. Adjudication Method for the Test Set

For the cadaver studies, no adjudication method is described. Measurements for positional and trajectory errors are typically objective and can be directly measured.
For the AI segmentation validation, the manual segmentations were "approved by US physicians." This suggests a consensus or review process, but the specific adjudication method (e.g., 2+1, 3+1) is not detailed.

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

The document does not indicate that an MRMC comparative effectiveness study was done to evaluate how human readers improve with AI vs. without AI assistance. The AI component is described as providing an "improved virtual 3D spine model" but its impact on human reader performance is not measured in this submission.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, a standalone performance evaluation was conducted for the AI segmentation algorithm. The "mean Dice coefficient was calculated" to measure the quality of the algorithm's segmentation compared to manual ground truth. This is a common metric for evaluating the performance of segmentation algorithms independently.

7. The Type of Ground Truth Used

For system accuracy (positional/trajectory errors): The ground truth was based on physical measurements of actual screw tip position and orientation in cadavers.
For AI segmentation algorithm: The ground truth was established by manual segmentations approved by US physicians.

8. The Sample Size for the Training Set

The document does not specify the sample size for the training set used for the Convolutional Neural Network (CNN) based AI spine segmentation algorithm. It only mentions that the algorithm has been "added to provide an improved virtual 3D spine model."

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

The document does not explicitly state how the ground truth for the training set of the AI algorithm was established. While it mentions manual segmentations by US physicians for the validation set, it does not detail the process for the training data. It's common practice for training data ground truth to also be established by expert annotation, but this is not explicitly confirmed in the provided text.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 17, 2022

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

Re: K220905

Trade/Device Name: xvision Spine System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: October 20, 2022 Received: October 20, 2022

Dear Janice 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 (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.

{1}------------------------------------------------

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 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.

Jesse Muir-S

For: Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K220905

Device Name xvision Spine System

Indications for Use (Describe)

Posterior Pedicle Screw Placement in the thoracic and sacro-lumbar region.
Posterior Screw Placement in C3-C7 vertebrae
Iliosacral Screw Placement

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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the

for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) SUMMARY

Augmedics xvision Spine System

Submitter

Augmedics Ltd. 1 Ha-Tsmikha St. Yokneam Illit. 2069205 Israel

Phone: +972-4-3730111 Facsimile: +972-4-3730850

Contact Person: Tami Harel Date Prepared: November 17, 2022

Name of Device: xvision Spine System

Common or Usual Name: XVS

Classification Name: Orthopedic Stereotaxic Instrument (21 CFR 882.4560)

Regulatory Class: Class II

Product Code: OLO

Predicate Device: xvision Spine, manufactured by Augmedics Ltd. Israel (K211188)

Reference Devices:

Al-Rad Companion (Musculoskeletal), manufacture by Siemens Medical Solutions USA (K193267) ARAI Surgical Navigation System, Holo Surgical, Inc. (a subsidiary of Surgalign Spine Technologies) (K211254).

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. 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 CT imagery of the anatomy. This can include the following spinal implant procedures:

-Posterior Pedicle Screw Placement in the thoracic and sacro-lumbar region.
-Posterior Screw Placement in C3-C7 vertebrae
-Iliosacral Screw Placement

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.

{4}------------------------------------------------

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 following modifications have been applied to the previously cleared XVS system:

Summary of Technological Characteristics

The modified xvision Spine System is similar in its technological features to its predicate device, the cleared xvision System. Both systems include very similar hardware and software components, with the following basic components: software, Headset with optical tracking camera, single use passive reflective markers, rigid reference point, and reusable tool adaptors. The Headset in both systems is positioned on the surgeon's head and is designed to provide 2D and stereoscopic 3D augmented reality (AR) display with overlaid navigation information, onto patient's anatomy. The software in both systems is designed for real time calculation and display of the spatial position of the tip of the surgical instruments relative to patient's anatomy. Both systems share the same safety features and are compatible with similar intraoperative scanners. Both systems follow similar fundamental principles of operation.

	xvision Spine(Subject device)	xvision Spine (K211188)(Predicate device)	Conclusion
Intended Use	The xvision Spine System,with xvision Spine SystemSoftware, is intended as anaid for precisely locatinganatomical structures ineither open or percutaneous	The xvision Spine System,with xvision Spine SystemSoftware, is intended as anaid for precisely locatinganatomical structures in eitheropen or percutaneous spine	Identical
	xvision Spine(Subject device)	xvision Spine (K211188)(Predicate device)	Conclusion
	spine procedures. Their useis indicated for any medicalcondition in which the use ofstereotactic surgery may beappropriate, and wherereference to a rigidanatomical structure, such asthe spine or pelvis, can beidentified relative to CTimagery of the anatomy.The Headset of the xvisionSpine System displays 2Dstereotaxic screens and avirtual anatomy screen. Thestereotaxic screen isindicated for correlating thetracked instrument location tothe registered patientimagery. The virtual screen isindicated for displaying thevirtual instrument location inrelation to the virtual anatomyto assist in percutaneousvisualization and trajectoryplanning.The virtual display should notbe relied upon solely forabsolute positionalinformation and shouldalways be used inconjunction with the	procedures. Their use isindicated for any medicalcondition in which the use ofstereotactic surgery may beappropriate, and wherereference to a rigid anatomicalstructure, such as the spine orpelvis, can be identifiedrelative to CT imagery of theanatomy.The Headset of the xvisionSpine System displays 2Dstereotaxic screens and avirtual anatomy screen. Thestereotaxic screen is indicatedfor correlating the trackedinstrument location to theregistered patient imagery.The virtual screen is indicatedfor displaying the virtualinstrument location in relationto the virtual anatomy to assistin percutaneous visualizationand trajectory planning.The virtual display should notbe relied upon solely forabsolute positional informationand should always be used inconjunction with the displayedstereotaxic information
Indication for Use	Spinal implant procedures:- Posterior Pedicle ScrewPlacement in the thoracicand sacro-lumbar region.- Posterior ScrewPlacement in C3-C7vertebrae- Iliosacral ScrewPlacement	Spinal implant procedures,such as Posterior PedicleScrew Placement in thethoracic and sacro-lumbarregion.	Expandedindication for usefor placing screwsin additional spinesegments.This change doesnot alter theintended use ofthe device for itsuse as an aid inlocalization duringspine surgery.
User Population	Orthopedic surgeons orneurosurgeons	Orthopedic surgeons orneurosurgeons	Identical
	xvision Spine(Subject device)	xvision Spine (K211188)(Predicate device)	Conclusion
Intended UseEnvironment	Operating Room	Operating Room	Identical
Main systemcomponents	• Headset with near eyesee-through display andtracking camera• Software application• Flat reflective markers• Tool adaptors• Reference point: PatientClamp and Perc Pin• Accessories: Panel PC,Roll Stand, 8" Tablet(Remote UI)	• Headset with near eye see-through display andtracking camera• Software application• Flat reflective markers• Tool adaptors• Reference point: PatientClamp and Perc Pin• Accessories: Panel PC,Roll Stand, 8" Tablet(Remote UI)	Identical
Modes ofOperation	• Patient Preparation• System Set-up• Intraoperative scan• Scan Import• Patient Registration• Navigation	• Patient Preparation• System Set-up• Intraoperative scan• Scan Import• Patient Registration• Navigation	Identical
Rigid referencepoint	• Patient Clamp attached tothe spinous process• Perc Pin inserted into thePSIS	• Patient Clamp attached tothe spinous process• Perc Pin inserted into thePSIS	Identical
Instrument (Tool)Adaptors	• Reusable• universal (connects tovarious tools, not system-specific)• VP & Ergonomic (systemspecific adaptors)	• Reusable• universal (connects tovarious tools, not system-specific)• VP & Ergonomic (systemspecific adaptors)	Identical
LocalizationTechnology	Optical	Optical	Identical
Optical Tracker	Single infrared camera,positioned 0.5m abovetracked objects	Single infrared camera,positioned 0.5m abovetracked objects	Identical
Tracking	6 DOF	6 DOF	Identical
System AccuracyRequirement	System Level Accuracy witha mean 3D positional error of2.0mm and mean trajectoryerror of 2°	System Level Accuracy with amean positional error of2.0mm and mean trajectoryerror of 2°	Identical
Imaging Modality	X-Ray Based Imaging	X-Ray Based Imaging	Identical
	xvision Spine(Subject device)	xvision Spine (K211188)(Predicate device)	Conclusion
MedicalDeviceInterfaces	O-arm Imaging System Ziehm Vision FD Vario 3D C-Arm and RFD 3D Siemens CIOS Spin Airo system by Brainlab GE OEC 3D scanner	O-arm Imaging System Ziehm Vision FD Vario 3D C-Arm and RFD 3D Siemens CIOS Spin Airo system by Brainlab	SimilarThe additionalintra-op scannerhas similartechnologicalcharacteristics asthe other scannersthat the predicatedevice iscompatible with(i.e., DICOMscans, resolutionand FOV). No newquestions of safetyor effectivenessare raised
Display Features	2D images: axial and sagittal3D modelTrajectoriesTrajectory guidanceInstrument's tip view3D transparent3D OFF (only 2D)3D follow instrumentmovement	2D images: axial and sagittal3D modelTrajectoriesTrajectory guidanceInstrument's tip view3D transparent3D OFF (only 2D)3D follow instrumentmovement	Identical
Segmentation and3D modelgeneration	Two thresholds are used toselect the input CT values(i.e., HU) to the algorithm thatcreates the 3D model, todistinguish the spine from thebackground: Threshold on the CT scan values (HU) Threshold on the AI segmented CT values that were masked as Spine. AI segmented CT values are derived from an AI based spine segmentation algorithm that is applied on the CT scan	A single threshold is used toselect the input CT values(i.e., HU) to the algorithm thatcreates the 3D model, todistinguish the spine from thebackground: Threshold on the CT scan values (HU)	SimilarIn both systemsthe 3D model iscreated from CTvalues, that arehigher thanapplied threshold,to distinguishspine frombackground.Adding the optionto use AI spinesegmented CTvalues forimproved 3Dmodel does notalter the systemintended use, itsfundamentaltechnology orprinciples ofoperation. Thus,
	xvision Spine(Subject device)	xvision Spine (K211188)(Predicate device)	Conclusion
			no new safety oreffectivenessquestions areraised.Using Al basedalgorithms forspinesegmentation ofthe referencedevices furthersupports thesubstantialequivalence of thisadditional feature
Communicationbetween Scannerandplatform/computer	USB & LAN connectivityusing DICOM	USB & LAN connectivity usingDICOM	Identical
Display and OpticsTechnology	Augmented Reality usingnear eye see-throughdisplay; data displayed onpatient's anatomy	Augmented Reality using neareye see-through display; datadisplayed on patient'sanatomy	Identical
Communicationbetween Headsetand computer	Wireless, encrypted	Wireless, encrypted	Identical
SupportedFrequencies &Transmissionprotocol	2.4GHZ & 5 GHz802.11g/n/ac	2.4GHZ & 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
Headset powersource	Li-ion rechargeable battery	Li-ion rechargeable battery	Identical
Number ofsupportedHeadsets	Two	Two	Identical

A table comparing the key features of the subject and the predicate devices is provided below:

{5}------------------------------------------------

{6}------------------------------------------------

{7}------------------------------------------------

{8}------------------------------------------------

Performance Data

The following testing was conducted to evaluate the device:

{9}------------------------------------------------

. The system's accuracy was validated in two cadaver studies, in which screws were positioned in C3-C7 cervical vertebrae and in the sacro-iliac segment. The positional and trajectory errors were calculated as the difference between the actual and virtual screw tip position, and the difference between the screw orientation and its recorded virtual trajectory. Additionally, clinical accuracy was evaluated using the Gertzbein-Robbins score by viewing the post-op scans.
. The performance of the AI segmentation algorithm was validated on a set of intra-op CT scans by comparing it with manual segmentations that were approved by US physicians. The mean Dice coefficient was calculated as the measured quality of the algorithm.
Software verification and validation testing was conducted as required by IEC 62304 and FDA guidance on general principles of software validation, January 11, 2002.

All performance testing demonstrates that the xvision System performs according to specifications and functions as intended.

Conclusions

The xvision Spine System is substantially equivalent to its predicate, the cleared xvision Spine System. Both systems have the same intended use, technological characteristics, and principles of operation. The expanded indications do not alter the intended surgical use of the device and do not affect its safety and effectiveness when used as labeled. None of the minor differences in technology raise new types of safety or effectiveness questions. Performance data demonstrated that the xvision Spine system 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).