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 System (XVS) is an image-guided navigation system designed to assist surgeons in placing pedicle screws accurately, during open or percutaneous computer-assisted spinal surgery by displaying stereoscopic augmented reality (AR) navigation onto the patient anatomy. The system consists of dedicated software running on a PC, a 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 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 purpose of this 510(k) submission is to introduce a new registration algorithm that enables registering a 3D CT scan that was acquired prior to surgery (pre-operative CT) using 2D X-ray images, taken intra-operatively with a C-Arm. As part of the development of this registration method, the company developed a new software algorithm that includes a deep learning-based spine segmentation algorithm that segments individual vertebrae including the sacrum and ilium. The segmentation output is used as an input to the new registration algorithm.

The indications for use of the subject device compared to its predicate are expanded and include the use of patient's X-ray images for registration and support of angular and lateral procedures requiring access to the disc space and sacro-iliac joint. These modifications do not alter the intended purpose of the system as an aid in localization of anatomical structures during spine surgery or its principles of operation, it just enables additional inputs for registration and supports navigation in additional traiectories.

AI/ML Overview

Here's a summary of the acceptance criteria and study information for the xvision Spine System, based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
System Level Accuracy	Mean 3D positional error of 2.0mm and mean trajectory error of 2°
Segmentation Algorithm Performance	Mean Dice coefficient calculated for segmentation algorithm (specific value not explicitly stated, but stated to be comparable to predicate's full spine segmentation algorithm performance).

Study Details

1. Sample Size Used for the Test Set and Data Provenance:

Registration Accuracy and Overall System Accuracy (Phantom Tests): Tests were performed using "phantoms" under different scenarios simulating clinical conditions. The exact number of phantoms or test cases within these phantom studies is not specified.
System Accuracy (Cadaver Studies): Three cadaver studies were conducted. The number of individual screws positioned or specific cadaver count is not specified, but it covered sacro-iliac, sacro-lumbar, thoracic, and C3-C7 vertebrae levels.
Segmentation Algorithm Validation: "A set of CT scans" was used for validation. The exact number of CT scans is not specified.
Data Provenance: Not explicitly stated for specific datasets. Phantom tests are simulated. Cadaver studies are typically prospective. The CT scans for segmentation validation were reviewed by "US physicians," implying the retrospective or prospective origin of this data could be from US sources, but this is not definite.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

Cadaver Studies: Ground truth for positional and trajectory errors was determined by measuring the difference between actual and virtual screw tip positions and orientations. Clinical accuracy was evaluated using the Gertzbein-Robbins score by viewing post-op scans. The number and qualifications of experts involved in this evaluation are not specified.
Segmentation Algorithm Validation: Ground truth was established by "manual segmentations that were approved by US physicians." The number of physicians and their specific qualifications (e.g., years of experience, specialty) are not specified.

3. Adjudication Method for the Test Set:

The document does not explicitly describe an adjudication method (e.g., 2+1, 3+1). For the segmentation algorithm, manual segmentations were "approved by US physicians," which could imply a consensus or review process, but details are not provided.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No MRMC comparative effectiveness study involving human readers with and without AI assistance is mentioned in the provided text. The study focuses on the device's standalone performance and its comparison to its predicate.

5. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:

Yes, a standalone performance evaluation was done for the segmentation algorithm. Its performance was validated against manual segmentations.
The system-level accuracy and registration accuracy were also evaluated as standalone (device-only) performance, using phantoms and cadavers, measuring inherent accuracy rather than human-AI interaction.

6. The Type of Ground Truth Used:

Cadaver Studies:
- Positional and Trajectory Errors: Based on measurements of actual vs. virtual screw tip positions and orientations. This is an objective, measured ground truth.
- Clinical Accuracy: Evaluated using the Gertzbein-Robbins score by viewing post-op scans. This relies on expert assessment of imaging.
Segmentation Algorithm Validation: Expert consensus/manual annotation, as it was compared with "manual segmentations that were approved by US physicians."

7. The Sample Size for the Training Set:

The document does not specify the sample size for the training set used for the deep learning-based spine segmentation algorithm.

8. How the Ground Truth for the Training Set Was Established:

The document does not specify how the ground truth for the training set was established for the deep learning-based spine segmentation algorithm. It only mentions that the validation of the algorithm was done by comparing it with manual segmentations approved by US physicians.

Summary

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October 16, 2024

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

Re: K241481

Trade/Device Name: xvision Spine System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: SBF Dated: May 24, 2024 Received: September 16, 2024

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.

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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" (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 QS 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 Rule"). 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-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 medical devices and radiation-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-regulatory

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assistance/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,

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) K241481

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 Facsimile: +972-4-3730850 Contact Person: Tami Harel Date Prepared: Mav 24, 2024

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 by Augmedics Ltd. Israel (K220905)

Reference Devices:

INTAI Surgery Navigation System, manufactured by Intai Technology Corporation (K180523).

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.

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

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The Headset of the xvision Spine System displays 2D stereotaxic screens and a virtual anatomy screen. The stereotaxic screen is indicated for correlating the tracked instrument location to the registered patient imagery. The virtual screen is indicated for displaying the virtual instrument location in relation to the virtual anatomy to assist in percutaneous visualization and trajectory planning.

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

Device Description

Summary of Technological Characteristics

The modified xvision Spine System is similar in its technological features to its predicate device, the cleared xvision Spine 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 the 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 the patient's anatomy. Both systems share the same safety features and follow similar fundamental principles of operation.

The modified XVS system offers an additional registration method, as an alternative to the cleared registration method using an intraoperative 3D scan. This new registration algorithm enables registering 3D scan that was taken pre-operatively with patient's anatomy using 2D X-ray images taken

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intra-operatively. The aim of both cleared and proposed registration methods is to align the patient's anatomy with the patient's CT scan.

Additionally, the indications for use were broadened to support navigation in additional trajectories (angular and lateral procedures requiring access to the disc space and Sacro-Iliac joint). Expanding the navigation capabilities to additional trajectories, does not change the system's technological characteristics since, regardless to the angle or path of the trajectory, the aim of the system is to enable accurate navigated trajectory. Phantom and Cadaver studies were used to demonstrate that the performance of the modified XVS system meets the same acceptance criteria as the cleared device. A table comparing the key features of the subject and the predicate devices is provided below:

	xvision Spine System(subject device)	xvision Spine System (K220905)(predicate device)	Conclusion
Intended 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	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	Identical
Indications for Use	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	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 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	Similar. The additional registration method and spinal procedures, added to the indications for use, do not constitute a new intended use. The intended use of the XVS system is as an aid for precisely locating anatomical structures in either open or percutaneous spine procedures. All added indications for use fall within this general intended use. Moreover, the added indications, do not raise different questions of safety and effectiveness, and do not significantly increase a safety or effectiveness concern previously raised by the predicate device
	xvision Spine System(subject device)	xvision Spine System(K220905)(predicate device)	Conclusion
			Furthermore, thischange doesn't impactthe anatomicalstructure, the patientpopulation or the clinicalcontext in which thedevice is being used.Hence, the proposedchange in indications foruse does not constitutea new intended use anda comparison to thepredicate device is stillmeaningful and theproduct can beconsidered substantiallyequivalent with respectto Intended Use andIndications for Use.
User Population	Orthopedic surgeons orneurosurgeons	Orthopedic surgeons orneurosurgeons	Identical
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• Computer, roll stand orCart• C-ARM Ring Adapter	• Headset with near eyesee-through display andtracking camera.• Software application• Flat reflective markers• Tool adaptors• Reference point: PatientClamp and Perc Pin• Computer, roll stand	SimilarThe Ring Adapter wasadded to support thenew registrationmethod. This addedcomponent does notalter the intended use ofthe XVS system. Thequestions of accuratebeads' detection inimaging and accuratecalculation of the spatialposition of the RingAdapter from thereference frame arecommon to all theconfigurations of theXVS registrationmarkers. Thus, addingthis component doesnot raise any newquestions of safety andeffectiveness.
	xvision Spine System(subject device)	Xvision Spine System(K220905)(predicate device)	Conclusion
Registrationmethods	IntraOp – requiring IntraOp 3D scan (Z-link & X-link) 2D-3D (PreOp), requiring PreOp 3D CT scan and at least two IntraOp Xray images	IntraOp – requiring IntraOp 3D scan (Z-link & X-link):	SimilarBoth registration methods are based on the same fundamental technology and principles of operation.Overall system accuracy while using the 2D-3D method was verified to be comparable to the device accuracy while using the IntaOp method. Thus, no new questions of safety or efficacy are raised. The reference device (cleared under K180523) further supports the substantial equivalence of this additional registration method
Rigid referencepoint	Patient Clamp attached to the spinous process Perc Pin inserted into the PSIS	Patient Clamp attached to the spinous process Perc Pin inserted into the PSIS	Identical
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
LocalizationTechnology	Optical	Optical	Identical
ReflectiveMarkers	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
	xvision Spine System(subject device)	xvision Spine System(K220905)(predicate device)	Conclusion
TrackingAlgorithm	Perspective N-point	Perspective N-point	Identical
SystemAccuracyRequirement	System Level Accuracy witha mean 3D positional error of2.0mm and mean trajectoryerror of 2°	System Level Accuracy witha mean positional error of2.0mm and mean trajectoryerror of 2°	Identical
Depp-learningbased spinesegmentationalgorithms	• Full spine anatomysegmentation frombackground• Segmentation of singlespine vertebra	• Full spine anatomysegmentation frombackground	SimilarThe single vertebrasegmentation algorithmwas added to supportthe new registrationmethod. It does not alterthe intended use of thesystem as an aid inlocalization during spinesurgery. The addedalgorithm is based onthe same CNNarchitecture as the fullspine segmentationalgorithm.The performance of thesingle spine vertebraalgorithm was verified,using the same metrics(i.e., DICE coefficient),to be comparable to theperformance of the fullspine segmentationalgorithm.Thus, no new questionsof safety or efficacy areraised
Imaging Modality	X-Ray Based Imaging	X-Ray Based Imaging	Identical
Medical DeviceInterfaces	• O-arm Imaging System• Ziehm Vision FD Vario 3DC-Arm and RFD 3D• Siemens CIOS SPin• Airo system by Brainlab• ExcelsiusGPSRound C-ARMS:GE OEC 9900 Elite, GE OEC9800 and 9800 plus all 9" &12" models	• O-arm Imaging System• Ziehm Vision FD Vario3D C-Arm and RFD 3D• Siemens CIOS SPin• Airo system by Brainlab• ExcelsiusGPS	SimilarSupport to C-ARMmodels was added dueto adding the newregistration method.Xray images that aretaken by these C-ARMmodels, are transferredto the XVS system.Adding the ability toacquire Xray imagesdoes not alter the
	xvision Spine System(subject device)	xvision Spine System(K220905)(predicate device)	Conclusion
			intended use of the XVs system as an aid in localization during spine surgery. Transferring Xray images to the system is similar to transferring 3D CT scans and does not raise any new questions of safety or effectiveness.
Display Opticsand 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
Communicationbetween Headsetand computer	Wireless, encrypted	Wireless, encrypted	Identical
SupportedFrequencies &Transmissionprotocol	5 GHz802.11g/n/ac	2.4GHZ & 5 GHz802.11g/n/ac	Identical
Frame rate ofdisplayedimages	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
OpticalDistortion	<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

The following testing was conducted to evaluate the device:

Cleaning validation according to ANSI/AAMI ST98:2022 and shipping validation according to ISTA . 2A were performed on the new component, i.e., the Ring Adapter

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. Registration accuracy and overall system accuracy were tested using phantoms, under different scenarios simulating clinical conditions. Phantom tests were performed when using the cleared registration methods and the added new registration method.
. The system's accuracy was validated in three cadaver studies in which screws were positioned in the sacro-iliac, sacro-lumbar, thoracic, and C3-C7 vertebrae levels. The positional and traiectory 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 segmentation algorithm was validated on a set of 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.
. Human Factors Usability Testing was conducted in accordance with the FDA Guidance Documents, Applying Human Factors and Usability Engineering to Medical Devices (2016) and Application of Human Factors Engineering Principles for Combination Products: Questions and Answers (2023) and IEC 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices. Human Factors Usability Testing was conducted with intended users in a simulated use environment to ensure the user needs and intended use requirements were met.

All performance testing demonstrates that the xvision Spine 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).