The VisAR System is intended as an aid for precisely locating anatomical structures in either open or percutaneous spine procedures. VisAR is indicated for any medical condition in which the use of stereotaxic surgery may be appropriate, and where reference to at least one rigid anatomical structure, such as the spine or iliac crests, can be identified relative to CT imagery of the anatomy. This can include guidance for procedures, such as Posterior Pedicle Screw Placement in the thoracic and sacro-lumbar region.

VisAR displays a virtual screen for stereoscopic 3D images acquired from CT sources. It is intended to enable users to segment previously acquired 3D datasets, overlay, and register these 3D segmented datasets with the anatomy of the patient in order to support intraoperative analysis and guidance.

The virtual screen is indicated for displaying the virtual instrument location to the virtual anatomy to assist in visualization and trajectory planning for both open and percutaneous surgeries.

Device Description

The VisAR system is an image-guided navigation system that is designed to assist surgeons in placing pedicle screws accurately, during open or percutaneous spinal surgery. The system consists of Novarad's immersive augmented reality software running on the Microsoft Hololens 2 headset, image visible ARTags (AprilTags), a pre-operative planning workstation and the Novarad PACS server. It uses optical tracking technology to co-localize the virtual 3D image datasets to the patient and displays to the surgeon the location of pre-operatively planned operative tracks and the tracked surgical instruments relative to the acquired intraoperative patient's scan, onto the surgical field. The 3D scanned image, along with tracking information, are projected to the surgeons' retina using a transparent near-eye display stereoscopic headset, allowing the surgeon to both look at the navigation data at the same time.

AI/ML Overview

Here's a summary of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Stated Goal)	Reported Device Performance
System Level Accuracy: Mean positional error < 3.0 mm	Mean Overall Positional Error: 1.9 mm (STD: 0.9 mm)
System Level Accuracy: Mean trajectory error < 3°	Mean Overall Trajectory Angle Error: 2.4° (STD: 1.2°)
	96% of pedicle screws placed correctly (Grades A and B on Gertzbein-Robbins Scale)
Performance of Headset display (FOV, resolution, luminance, transmittance, distortion, contrast ratio, temporal, display noise, motion-to-photon latency)	Demonstrated performance (all elements verified)
User Needs Validation	All requirements met with no new safety/effectiveness issues
Electrical Safety (ANSI AAMI ES60601-1)	Tested in accordance with standard
Electromagnetic Compatibility (IEC 60601-1-2:2014)	Tested in accordance with standard
Sterilization Validation (ANSI/AAMI/ISO 11137-1)	Tested and successfully completed
Reusable components cleaning and sterilization	Validated per manufacturer instructions
Headset cleaning and disinfection	Performed according to FDA guidance
Biocompatibility (ISO 10993-1:2018)	All tests successfully completed
Software Verification and Validation (IEC 62304:2015)	Conducted as required
Human Factors and Usability (IEC 62366-1:2015+AMD1:2020)	Conducted as required

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

Sample Size (Accuracy Testing): 7 cadavers; 124 pedicle screws inserted.
Data Provenance: Not explicitly stated, but the use of cadavers implies the data is retrospective for the purpose of the study (performed in a lab setting rather than on live patients). The testing was conducted in the context of the device manufacturer (Novarad, Provo, Utah), suggesting a U.S. origin for the experimental setup.

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

Number of Experts: One neuroradiologist, in addition to spine surgeons who performed the insertions.
Qualifications of Experts: The ground truth for preoperative planning (pedicle entry point, trajectory, and depth) was established by a neuroradiologist. Spine surgeons used the device for screw insertion. The comparison of actual screw placement to planned pathways was done by fusing pre- and post-operative CT scans.

4. Adjudication Method for the Test Set

The provided text does not explicitly detail an external adjudication method (e.g., 2+1, 3+1). The accuracy evaluation involved:

A neuroradiologist annotating preoperative CT images for planned screw placement.
Spine surgeons performing the screw insertions using VisAR.
Comparison of the actual screw placement (from postoperative CT) to the annotated virtual pathway (from preoperative CT) using vector coordinates.
Evaluation using the Gertzbein-Robbins scale.
This process indicates an internal comparison against a pre-established plan rather than an external adjudication of the device's output by multiple independent experts.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or described. The study focused on the standalone accuracy of the device in cadaveric models. The text explicitly states: "There are no clinical tests to compare VisAR and predicate device system (XVS), as they are software products that retrieve and display images and information."

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

Yes, the accuracy testing described in the "Performance Data" section represents a standalone performance evaluation of the device's guidance capabilities when used by surgeons. While surgeons were "in the loop" for inserting screws, the metrics (positional error, trajectory angle error, Gertzbein-Robbins scale) evaluate the device's accuracy in guiding those surgeons relative to a pre-planned trajectory, not a comparison against unassisted human performance.

7. The Type of Ground Truth Used

The ground truth for the accuracy study was a combination of:

Expert Consensus/Annotation: Preoperative plans (pedicle entry point, trajectory, depth) were determined and annotated by a neuroradiologist on CT images.
Reference standard (Post-operative imaging): The actual screw placement was determined from postoperative CT scans, which were then fused with the preoperative CT scans to spatially compare the actual placement against the neuroradiologist's annotated virtual pathway.
Clinical Scale: The Gertzbein-Robbins scale was also used for assessment of screw placement, which is a common clinical measurement.

8. The Sample Size for the Training Set

The document does not provide any information regarding the sample size used for the training set of the VisAR system's algorithms.

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

The document does not provide any information on how the ground truth for the training set was established.

Summary

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Image /page/0/Picture/0 description: The image shows the date May 27, 2022. The month is May, the day is 27, and the year is 2022. The date is written in a clear, sans-serif font. The text is black against a white background.

U.S. FOOD & DRUG
ADMINISTRATION

Novarad Corporation Doug Merrill Compliance Manager 3152 North University Avenue, Suite 200 Provo. Utah 84604

Re: K220146

Trade/Device Name: VisAR Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO, LLZ Dated: April 28, 2022 Received: April 28, 2022

Dear Doug Merrill:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

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

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

For comprehensive regulatory information about 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-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,

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) K220146

Device Name VisAR

Indications for Use (Describe)

The virtual screen is indicated for displaying the virtual instrument location to the virtual anatomy to assist in visualization and trajectory planning for both open and percutaneous surgeries.

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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K220146 510(K) SUMMARY

Submitter

Novarad Corporation 3152 North University Avenue, Suite 200 Provo, UT 84604 E-mail: doug.merrill(@novarad.net Phone: 801-642-1001 Contact Person: Doug Merrill Date Summary Prepared: 21 December 2021

Device Name

Trade Name: VisAR

Common or Usual Name: Stereotaxic Guidance System and Imaging Software

Classification Name: Orthopedic Stereotaxic Instrument

Regulation Number: 21 CFR 882.4560

Regulatory Class: Class II

Product Code: OLO and LLZ

Primary Predicate Device

K190929	xvision Spine system (XVS)	Augmedics Ltd.
---------	----------------------------	----------------

Additional Predicate Device

K172418	OpenSight	Novarad Corporation
---------	-----------	---------------------

Device Description

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reality software running on the Microsoft Hololens 2 headset, image visible ARTags (AprilTags), a pre-operative planning workstation and the Novarad PACS server. It uses optical tracking technology to co-localize the virtual 3D image datasets to the patient and displays to the surgeon the location of pre-operatively planned operative tracks and the tracked surgical instruments relative to the acquired intraoperative patient's scan, onto the surgical field. The 3D scanned image, along with tracking information, are projected to the surgeons' retina using a transparent near-eyedisplay stereoscopic headset, allowing the surgeon to both look at the navigation data at the same time.

Indication for Use

The VisAR System is intended as an aid for precisely locating anatomical structures in either open or percutaneous spine procedures. VisAR is indicated for any medical condition in which the use of stereotaxic surgery may be appropriate, and where reference to at least one rigid anatomical structure, such as the spine or illac crests, can be identified relative to CT imagery of the anatomy. This can include guidance for procedures, such as Posterior Pedicle Screw Placement in the thoracic and sacro-lumbar region.

The virtual screen is indicated for displaying the virtual instrument location to the virtual anatomy to assust in visualization and trajectory planning for both open and percutaneous surgeries.

Summary of Technological Characteristics

The VisAR System is similar in its technological features to its primary predicate device, the xvision Spine System (K190929). Both systems are intended as an aid for precisely locating anatomical structures in either open or percutaneous orthopedic procedures and both systems consist of similar types of components and involve similar principles of operation. Both systems retrieve and display images from DICOM compliant medical imaging modalities and/or systems. They are intended to be used in healthcare settings, such as hospitals, clinics, and procedure rooms. They are intended to provide qualified medical professionals with a variety of tools and software features for the viewing, analysis, and annotation of medical images. Both systems includes a see-through near eve display headset, which is positioned on the surgeon's head, for displaying overlaid navigation information of stereoscopic 3D images from DICOM compliant medical imaging modalities onto patient's anatomy.

The VisAR System is similar in its technological features to predicate device OpenSight (K172418) although this device has been previously cleared for pre-operative use only.

There are no clinical tests to compare VisAR and predicate device system (XVS), as they are software products that retrieve and display images and information.

There are minor differences between the subject and predicate devices; however, these differences do not raise different questions of safety or effectiveness when compared to the primary predicate device. Both systems utilize stereotaxic technologies within the same surgical workflow. Minor differences in the optical tracking systems, display features, and medical device interfaces are addressed by performance testing.

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

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Item	Subject DeviceVisAR	Predicate Device(primary)xvision Spine system (XVS)K190929	Predicate DeviceOpenSightK172418	Comments
Intended Use /Indidcations forUse	The VisAR System isintended as an aid forprecisely locatinganatomical structures ineither open or percutaneousspine procedures. VisAR isindicated for any medicalcondition in which the useof stereotaxic surgery maybe appropriate, and wherereference to at least onerigid anatomical structure,such as the spine or iliaccrests, can be identifiedrelative to CT imagery ofthe anatomy. This caninclude guidance forprocedures, such asPosterior Pedicle ScrewPlacement in the thoracicand sacro-lumbar region.VisAR displays a virtualscreen for stereoscopic 3Dimages acquired from CTsources. It is intended toenable users to segmentpreviously acquired 3Ddatasets, overlay, andregister these 3D segmenteddatasets with the anatomyof the patient in order tosupport intraoperativeanalysis and guidance.The virtual screen isindicated for displaying thevirtual instrument locationin relation to the virtualanatomy to assist invisualization and trajectoryplanning for both open andpercutaneous surgeries.	The xvision SpineSystem, with xvisionSpine System Software, isintended as an aid forprecisely locatinganatomical structures ineither open orpercutaneous spineprocedures. Their use isindicated for any medicalcondition in which theuse of stereotacticsurgery may beappropriate, and wherereference to a rigidanatomical structure,such as the spine, can beidentified relative to CTimagery of the anatomy.This can include thespinal implantprocedures, such asPosterior Pedicle ScrewPlacement in the thoracicand sacro-lumbar region.The Headset of thexvision Spine Systemdisplays 2D stereotaxicscreens and a virtualanatomy screen. Thestereotaxic screen isindicated for correlatingthe tracked instrumentlocation to the registeredpatient imagery. Thevirtual screen is indicatedfor displaying the virtualinstrument location inrelation to the virtualanatomy to assist inpercutaneousvisualization andtrajectory planning.The virtual displayshould not be relied	OpenSight is intendedto enable users todisplay, manipulate,and evaluate 2D, 3D,and 4D digital imagesacquired from CR, DX,CT, MR, and PTsources. It is intendedto visualize 3D imagingholograms of thepatient, on the patient,for pre-operativelocalization and pre-operative planning ofsurgical options.OpenSight is designedfor use only withperformance-testedhardware specified inthe userdocumentation.OpenSight is intendedto enable users tosegment previouslyacquired 3D datasets,overlay, and registerthese 3D segmenteddatasets with the sameanatomy of the patientin order to support pre-operative analysis.OpenSight is notintended forintraoperative use. It isnot to be used forstereotactic procedures.OpenSight is intendedfor use by trainedhealthcareprofessionals, includingsurgeons, radiologists,chiropractors,physicians,cardiologists,technologists, and	Equivalent
		and should always beused in conjunction withthe displayed stereotaxicinformation.	to better understandanatomy and pathologyof patient.
Intended UseEnvironment	Operating Room	Operating Room	Healthcaresettings, such ashospitals andclinics	Equivalent
Main SystemComponents	- Headset with near eye see-through display andtracking camera- Software application- Image visible ARTags(AprilTags)- Optical trackingtechnology	- Headset with near eyesee-through displayand tracking camera- Software application- Reflective markers-Flat- Instrument universalAdaptors- Reference point	- Headset with neareye see-throughdisplay and trackingcamera- Software application- Optical trackingtechnology	Utilizes thesame process
Modes ofOperation	- Patient Preparation- System Set-up- Preoperative scan- Preoperative planning- Intraoperative scan- Scan Import- Patient Registration- Navigation	- Patient Preparation- System Set-up- Intraoperative scan- Scan Import- Patient Registration- Navigation	- System Set-up- Preoperative scan- Preoperative planning- Scan Import- Patient Registration	Equivalent
LocalizationTechnology	Optical	Optical	Mesh surface maps	Equivalent
Optical Tracker	Has 3d sensors, andcameras for detecting theenvironment	Single infrared camera,positioned 0.5m abovetracked objects	Has 3d sensors, andcameras for detectingthe environment	Equivalent
Tracking	6 DOF	6 DOF	6 DOF	Equivalent
TrackingAlgorithm	Perspective N-pointfollowed by center rayoptimization	Perspective N-point	Not relevant	Equivalent
System AccuracyRequirement	System Level Accuracywith a mean positionalerror of 3.0mm and meantrajectory error of 3°	System Level Accuracywith a mean positionalerror of 2.0mm andmean trajectory error of2°	Not relevant	Equivalent toOrthopedicrequirement
Imaging Modality/ Data Sources	CT sources	X-Ray Based Imaging	CR, DX, CT, MR, andPT sources	Equivalent
Medical DeviceInterfaces	Pre-operative planningworkstationNovarad PACS server	O-arm Imaging SystemZiehm Vision FD Vario3DC-Arm and RFD 3D	Pre-operative planningworkstationNovarad PACS server	Utilizes thesame process
		Siemens CIOS SPinAiro system by Brainlab
Display Features	2D images: axial, sagittal,coronal and oblique3D real time renderingTrajectoriesTrajectory guidanceInstrument's tip view3D transparent	2D images: axial andsagittal3D modelTrajectoriesTrajectory guidanceInstrument's tip view3D transparent3D OFF (only 2D)3D follow instrumentmovement	2D images: axial,sagittal, coronal andoblique3D or 4D real timerenderingTrajectories3D transparent3D OFF (only 2D)	Equivalent -VisAR doesnot use a 3Dmodel
Software Interface(GUI)	Multiple heads up menudisplaysVoice controlsHand gestures	Black and blue style withprocedure task overviewin a menu and next/backtask flow. Softwarecontrols for images,instrument and plannedtrajectory management	Multiple heads upmenu displaysVoice controlsHand gestures	Equivalent
Communicationbetween Scannerandplatform/computer	WiFi communication withNovorad server, providesmedical scan	USB & LANconnectivity usingDICOM	WiFi communicationwith Novorad server,provides medical scan	Equivalent
Display andOpticsTechnology	Augmented Reality usingnear eye see-throughdisplay; data displayed onpatient's anatomy	Augmented Reality usingnear eye see-throughdisplay; data displayed onpatient's anatomy	Augmented Realityusing near eye see-through display; datadisplayed on patient'sanatomy	Equivalent
Communicationbetween Headsetand computer	Wireless, encrypted	Wireless, encrypted	Wireless, encrypted	Equivalent
Frame rate ofdisplayed images	60 fps	60 fps	60 fps	Equivalent
Headset powersource	Li-ion rechargeable battery	Li-ion rechargeablebattery	Li-ion rechargeablebattery	Equivalent

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Performance Data

The following testing was conducted to evaluate the device:

. Accuracy

Bench testing was performed on 7 cadavers. 124 pedicle screws were positioned using VisAR augmented reality navigation/guidance. The angular error and distance error were calculated.

Following CT, the pedicle entry point, trajectory, and depth were determined and annotated using NovaPACS software (Novarad, Provo, Utah) by a neuroradiologist. The annotated images were uploaded to VisAR and transformed to 3D images for surgical guidance. Spine surgeons used VisAR as the guidance device for pedicle

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screw insertion. The preoperative CT was fused with the postoperative CT and spatial locations of both the annotated virtual pathway and the actual screw placement were determined with vector coordinates.

The following tables summarize the results:

Overall Positional Error:

RegistrationMethod	Mean OverallPositionalError [mm]	STD OverallPositionalError [mm]	99%Upper Bound LimitOverall PositionalError [mm]
Optical Codes(ARTags,AprilTags)alignment	1.9	0.9	1.85-1.94

Overall Trajectory Angle Error:

Mean OverallTrajectory AngleError (deg)	STD OverallTrajectory AngleError (deg)	99%Upper Bound LimitOverall Trajectory AngleError (deg)
2.4	1.2	2.35-2.44

● Pedicle Screw Positioning Accuracy: Gertzbein-Robbins Scale1

Screw placement was also evaluated with the Gertzbein-Robbins scale, which is the clinical measurement of pedicle screw placement accuracy.

Gertzbein-Robbins Scale	Grades of pedicle screwspositioned in 3 cadavers
A: No breach	113
B: 0-2 mm	6
C: 2.1-4.0 mm	5
D: 4.1-6.0 mm	0
E: >6.0 mm	0

Accuracy Summary: ●

The overall mean positional error is 1.9 mm (STD: 0.9), with an angle of error of 2.4 degrees (STD: 1.2 degrees). 96% of the pedicle screws were placed correctly (grades A and B) when graded with the Gettzbein-Robbins scale.

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The system has demonstrated performance in 3D positional accuracy with a mean error lower than 3mm and in trajectory angle accuracy with a mean error lower than 3 degrees, in phantom and cadaver studies.

Performance of the Headset display was demonstrated by verifying the following elements: Field of View . (FOV), resolution, luminance, transmittance, distortion, contrast ratio, temporal, display noise and motion-tophoton latency.
User Needs validation - The system was validated with intended users in cadaver labs and simulated use tests to ensure the user needs and intended use requirements were met. All requirements were met and no new issues of safety or effectiveness were raised.
. Electrical safety was tested in accordance with ANSI AAMI ES60601-1, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
. Electromagnetic Compatibility (EMC) was tested in accordance with IEC 60601-1-2:2014, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests.
Sterilization validation for the single use components was conducted in accordance with the ● ANSI/AAMI/ISO 11137-1, Sterilization of health care products-Radiation-Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices. Additionally, shelf life and packaging testing were performed to support the labeled shelf life. All tests were successfully completed.
Reusable components are validated for cleaning and sterilization per manufacturer instructions. ●
Headset cleaning and disinfection vas performed according to FDA guidance "Reprocessing ● Medical Devices in Health Care Settings: Validation Methods and Labeling - Guidance for Industry and Food and Drug Administration Staff " (March 17, 2015).
. The biocompatibility of all patient contact materials was verified according to ISO 10993-1:2018 and FDA guidance on the use of ISO 10993-1, September 4, 2020. All tests were successfully completed.
Software verification and validation testing was conducted as required by IEC 62304:2015, Medical Device ● Software - Software Lifecycle processes.
. Human factors and usability testing was conducted as reguired by IEC 62366-1:2015+AMD1:2020, Medical devices - Part 1: Application of usability engineering to medical devices.

All performance testing demonstrates that the VisAR System performs according to specifications as intended.

Conclusions

The information provided above supports that the VisAR System is substantially equivalent to the identified predicate devices. Substantial equivalence has been demonstrated through a comparison of

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intended use, technological characteristics, as well as performance evaluations. The minor differences in indications do not alter the intended surgical use of the device and do not affect its safety and effectiveness when used as labeled. Performance data demonstrated that the VisAR System functions as intended without raising new safety or effectiveness concerns. The VisAR System can be considered substantially equivalent to the identified predicate devices.

1 S. D. Gertzbein and Stephen E. Robbins. Accuracy of pedicular screw placement in vivo. Spine, 15:1:11-14, 1990.

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).