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, can be identified relative to CT imagery of the anatomy. This can include the spinal implant procedures, such as Posterior Pedicle Screw Placement in the thoracic and sacro-lumbar region.

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 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.

AI/ML Overview

The provided text describes the performance data and testing conducted for the xvision Spine system, particularly focusing on its accuracy in guiding pedicle screw placement.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided document:

1. Acceptance Criteria and Reported Device Performance

The core acceptance criteria for the xvision Spine system relate to its positional and trajectory angle accuracy. The document implicitly sets these criteria by comparing the device's performance to the predicate device and by reporting the mean errors and 99% Upper Bound Limits (UBLs).

Metric	Acceptance Criteria (Implied)	Reported Device Performance (Phantom Study)	Reported Device Performance (Cadaver Study)
Overall Positional Error	≤ 2.0 mm (Mean)	0.63 - 0.954 mm (Mean)	1.98 mm (Mean)
		≤ 1.12 mm (99% UBL)	2.22 mm (99% UBL)
Overall Trajectory Angle Error	≤ 2° (Mean)	0.468 - 0.683° (Mean)	1.3° (Mean)
		≤ 1.08° (99% UBL)	1.47° (99% UBL)

Note: The document explicitly states: "Thus, the system has demonstrated performance in 3D positional accuracy with a mean error statistically significantly lower than 3mm and in trajectory angle accuracy with a mean error statistically significantly lower than 3 degrees, in phantom and cadaver studies." However, the "System Accuracy Requirement" for the device, as listed in the comparison table with the predicate, is 2.0mm positional error and 2° trajectory error. The reported performance is compared to this requirement rather than a broader 3mm/3degree standard. Therefore, the "Acceptance Criteria" column above reflects the stricter "System Accuracy Requirement" from the comparison table.

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

Phantom Study: The sample size for the phantom study is not explicitly stated in terms of the number of measurements or trials. However, it involved testing under "different conditions simulating clinical conditions such as: Headset mounted statically and Headset moving above the markers, different distances between the Headset and the markers, and different angles" and using two Z-link markers (Z1 and Z2).
Cadaver Study: The sample size is not explicitly stated for the cadaver study either, but it involved positioning pedicle screws percutaneously in "thoracic and sacro-lumbar vertebrae." The number of cadavers or screws tested is not provided.
Data Provenance:
- Phantom Study: The data provenance is laboratory bench testing. The country of origin is not specified, but the applicant company is located in Israel (Augmedics Ltd.).
- Cadaver Study: The data provenance is from a cadaver study. The country of origin is not specified. This would be considered a prospective study as it involves active experimentation.

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

The document does not specify the number of experts or their qualifications for establishing ground truth in either the phantom or cadaver studies.
For the cadaver study, the ground truth for positional error was derived from "the post-op scan," and for trajectory error, it was a "recorded planned/virtual trajectory." It implies an objective measurement rather than expert consensus on anatomical landmarks.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method (e.g., 2+1, 3+1, none) for the test sets. The ground truth appears to be based on direct measurements and pre-defined plans rather than subjective assessments requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. The studies focused on the accuracy of the device itself (standalone performance and cadaver-assisted performance), not on the improvement in human reader performance with or without AI assistance. The device is a navigation system, assisting surgeons during procedures, not an AI-assisted diagnostic tool for human readers.

6. Standalone (Algorithm Only) Performance

Yes, the performance data presented primarily focuses on the standalone performance of the xvision Spine system, particularly its accuracy. The "Bench testing" results demonstrate the algorithm's accuracy in a controlled environment, and the "cadaver study" validates this accuracy in a more realistic anatomical setting, demonstrating the system's ability to guide screw placement. The focus is on the precision of the stereotaxic instrument, not on human interpretation or analysis.

7. Type of Ground Truth Used

Phantom Study: The ground truth was established through known mechanical positions and precisely defined settings within the phantom, allowing for objective measurement of error from a pre-defined ideal.
Cadaver Study: The ground truth for positional error was derived from the post-operative scan (objective imaging data), and for trajectory error, it was compared to the recorded planned/virtual trajectory (pre-defined objective plan).

8. Sample Size for the Training Set

The document does not provide any information regarding a training set or its sample size. This is a medical device for surgical guidance, not a machine learning model that typically requires a separate training set. The descriptions focus on the validation of the system's accuracy and performance.

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

Since no training set is mentioned or implied for this type of medical device validation, there is no information on how ground truth for a training set was established.

Summary

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December 20, 2019

Image /page/0/Picture/1 description: The image shows 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 consists of a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below that.

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

Re: K190929

Trade/Device Name: xvision Spine system (XVS) Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: December 16, 2019 Received: December 16, 2019

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.

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

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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 (OS) 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,

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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510(k) Number (if known) K190929

Device Name

xvision Spine (XVS) Indications for Use (Describe)

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

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

□ Over-The-Counter Use (21 CFR 801 Subpart C)

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K190929

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: December 20, 2019

Name of Device: xvision Spine

Common or Usual Name: XVS

Classification Name: Orthopedic Stereotaxic Instrument (21 CFR 882.4560)

Regulatory Class: Class II

Product Code: OLO

Predicate Devices

StealthStation S8 Spine Software V1.0.0, manufactured by Medtronic Navigation, USA (K170011)

Reference Devices

OpenSight, manufactured by Novarad Corporation, USA, (K172418)

Device Description

Intended Use / Indications for Use

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

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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, can be identified relative to CT imagery of the anatomy. This can include the spinal implant procedures, such as Posterior Pedicle Screw Placement in the thoracic and sacro-lumbar region.

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.

Summary of Technological Characteristics

The xvision Spine System is similar in its technological features to its predicate device, the StealthStation S8 Spine Software V1.0.0 (K170011). Both systems are intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical and orthopedic procedures and both systems consist of similar types of components and involve similar principles of operation. Both systems use optical infrared camera(s) to track the position of the surgical instruments in relation to the surgical anatomy. A rigid reference point representing patient's anatomy, is connected to patient's anatomy throughout the procedure, in both systems. Additionally, in both the subject and predicate device, tool adaptors are used for affixing the tracked reflective markers to the surgical instruments. The xvision Spine system includes a Headset, which 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. In the predicate system, this navigation information is displayed on a monitor, which is part of the system's cart and is positioned to the side or in front of the surgeon. The use of a headset for presenting stereoscopic augmented reality (AR) display of patient's anatomy is not a new feature and has been previously cleared under K172418 for the OpenSight (reference device), although this device is not cleared to be used for intraoperative use. Similarly to the xvision Spine Headset, the reference device uses a see-through near eye display (Microsoft HoloLens) for displaying superimposed information of 2D images and 3D holograms from DICOM compliant medical imaging modalities onto patient's anatomy.

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

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	xvision Spine	StealthStation (K170011)[predicate device]	OpenSight (K172418)[reference device]
Intended Use /Indications forUse	The xvision Spine System,with xvision SpineSoftware, is intended as anaid for precisely locatinganatomical structures ineither open orpercutaneous spineprocedures. Their use isindicated for any medicalcondition in which the useof stereotactic surgery maybe appropriate, and wherereference to a rigidanatomical structure, suchas the spine, can beidentified relative to CTimagery of the anatomy.This can include the spinalimplant procedures, suchas Posterior Pedicle ScrewPlacement in the thoracicand sacro-lumbar region.The Headset of the xvisionSpine System displays 2Dstereotaxic screens and avirtual anatomy screen.The stereotaxic screen isindicated for correlating thetracked instrument locationto the registered patientimagery. The virtualscreen is indicated fordisplaying the virtualinstrument location inrelation to the virtualanatomy to assist inpercutaneous visualizationand trajectory planning.The virtual display shouldnot be relied upon solelyfor absolute positionalinformation and shouldalways be used inconjunction with thedisplayed stereotaxicinformation.	The StealthStation System,with StealthStation SpineSoftware, is intended as anaid for precisely locatinganatomical structures ineither open orpercutaneous neurosurgicaland orthopedic procedures.Their use is indicated forany medical condition inwhich the use ofstereotactic surgery may beappropriate, and wherereference to a rigidanatomical structure, suchas the spine or pelvis, canbe identified relative toimages of the anatomy.This can include thefollowing spinal implantprocedures, such as:• Pedicle Screw Placement• Iliosacral ScrewPlacement• Interbody DevicePlacement	OpenSight is intended toenable users to display,manipulate, and evaluate 2D,3D, and 4D digital imagesacquired from CR, DX, CT,MR, and PT sources. It isintended to visualize 3Dimaging holograms of thepatient, on the patient, forpreoperative localization andpre-operative planning ofsurgical options. OpenSight isdesigned for use only withperformance-tested hardwarespecified in the userdocumentation.OpenSight is intended toenable users to segmentpreviously acquired 3Ddatasets, overlay, and registerthese 3D segmented datasetswith the same anatomy of thepatient in order to support pre-operative analysis.OpenSight is not intended forintraoperative use. It is not tobe used for stereotacticprocedures.OpenSight is intended for useby trained healthcareprofessionals, includingsurgeons, radiologists,chiropractors, physicians,cardiologists, technologists,and medical educators. Thedevice assists doctors tobetter understand anatomyand pathology of patient
Intended UseEnvironment	Operating Room	Operating Room	Healthcaresettings, such as hospitals andclinics
	xvision Spine	StealthStation (K170011)[predicate device]	OpenSight (K172418)[reference device]
Main systemcomponents	Headset with near eyesee-through display andtracking camera Software application Reflective markers-Flat Instrument universaladaptors Reference point	Platform including cart,computer, monitor andtracking cameras Software application Reflective markers -Spheres Accessories (Instrumentadaptors, referencingsystem)	Headset with near eye see-through display Software application
Modes ofOperation	Patient Preparation System Set-up Intraoperative scan Scan Import Patient Registration Navigation	Patient Preparation System Set-up Intraoperative scan Scan Import Planning Patient Registration Navigation	System Set-up Scan import Patient Registration
LocalizationTechnology	Optical	Optical	Time of flight
Optical Tracker	Single infrared camera,positioned 0.5m abovetracked objects	Two infrared cameras,positioned 2-3m away fromtracked objects	No tracking- spatial mappingprovides a representation ofreal-world surfaces aroundthe device
Tracking	6 DOF	6 DOF	No tracking- spatial mappingprovides a representation ofreal-world surfaces aroundthe device
TrackingAlgorithm	Perspective N-point	Triangulation	No tracking- spatial mappingprovides a representation ofreal-world surfaces aroundthe device
System AccuracyRequirement	System Level Accuracywith a mean positionalerror of 2.0mm and meantrajectory error of 2°	System Level Accuracywith a mean positional errorof 2.0mm and meantrajectory error of 2°	Not relevant
Imaging Modality	X-Ray Based Imaging	X-Ray Based Imaging	CR, DX, CT, MR, and PT
Medical DeviceInterfaces	O-arm Imaging SystemZiehm Vision FD Vario 3DC-Arm and RFD 3DSiemens CIOS SPinAiro system by Brainlab	O-arm Imaging SystemZiehm Vision FD Vario 3DC-ArmISO-C 3D C-ArmOrbic 3D C-Arm	The system does not interfacedirectly with the imagingmodality
	xvision Spine	StealthStation (K170011)	OpenSight (K172418)
		[predicate device]	[reference device]
Display Features	2D images: axial andsagittal3D modelTrajectoriesTrajectory guidanceInstrument's tip view3D transparent3D OFF (only 2D)3D follow instrumentmovement	Look Sideways3DAnatomic OrthogonalTrajectory 1 and 2Trajectory GuidanceLook AheadProbe's EyeAP and LateralSynthetic AP and LateralMaximum IntensityProjectionVideo Input	Not reported
Software Interface(GUI)	Black and blue style withprocedure task overview ina menu and next/back taskflow. Software controls forimages, instrument andplanned trajectorymanagement	Black and gray style withprocedure task overview inleft menu option andnext/back task flow atbottom of the screen.Software controls forimages, planning andinstrument managementare contained in a right sidebar.	Software controls for windowlevel, segmentation andrendering, registration, motioncorrection, virtual tools (i.e,lines, distance & volumemeasurements) alignment,measure image intensityvalues, such asstandardized uptake value.
Communicationbetween Scannerandplatform/computer	USB & LAN connectivityusing DICOM	Network ConnectivityCD, DVD, USBDICOM ImportDICOM Export	WiFi communication withNovorad server, not ascanner
Display andOpticsTechnology	Augmented Reality usingnear eye see-throughdisplay; data displayed onpatient's anatomy	Data displayed on amonitor	Augmented Reality usingnear eye see-throughdisplay; data displayed onpatient's anatomy
Communicationbetween Headsetand computer	Wireless, encrypted	No Headset	Wireless, encrypted
Frame rate ofdisplayed images	60 fps	Not reported	60 fps
Headset powersource	Li-ion rechargeable battery	No Headset	Researchable battery

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Performance Data

The following testing was conducted to evaluate the device:

. Bench testing was conducted in order to demonstrate that the xvision-Spine system performs according to its requirements and specifications. In particular, overall system accuracy, image registration accuracy and tracking accuracy were tested using phantoms, under different conditions simulating clinical conditions such as: Headset mounted statically and

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Headset moving above the markers, different distances between the Headset and the markers, and different angles. The XVS system supports a Z-link patient registration method uses a known mechanical position between the registration that marker and the rigid reference marker. The Z-link method uses two optional Z markers to accommodate for different patients' size. Under all test conditions, the overall average image registration error was

1.103 mm or less. The following tables summarize the performance results demonstrated on phantoms:

Registration Method	Headset	Mean OverallPositionalError [mm]	STD OverallPositionalError [mm]	99%UBL*OverallPositionalError [mm]
Z-link (Z1 marker)	Static Headset	0.932	0.657	1.105
	Moving Headset	0.954	0.631	1.12
Z-link (Z2 marker)	Static Headset	0.715	0.542	0.857
	Moving Headset	0.63	0.54	0.772

Overall Positional Error:

Overall Trajectory Angle Error:

Headset	Mean OverallTrajectory AngleError [deg]	STD OverallTrajectory AngleError [deg]	99% UBL* OverallTrajectory AngleError [deg]
Static Headset	0.468	0.162	0.589
Moving Headset	0.683	0.44	1.08

*UBL (Upper Bound Limit)

Additionally, tracking accuracy was verified per ASTM F2554-10.

. The System's accuracy was also validated in a cadaver study, in which pedicle screws were positioned percutaneously in thoracic and sacro-lumbar vertebrae. The positional error was calculated as the difference between the actual screw tip position, derived from the post-op scan, and its planned/virtual tip, as recorded by the xvision-Spine system. The trajectory error was calculated as the difference between the screw orientation and its recorded planned/virtual trajectory. The following positional and trajectory angle errors were demonstrated:

Performancevalidation	Positional Error [mm]			Trajectory Angle Error [deg]
	Mean	StandardDeviation	99%UBL*	Mean	StandardDeviation	99%UBL*
XVS system	1.98	0.90	2.22	1.3	0.65	1.47

*UBL (Upper Bound Limit)

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Thus, the system has demonstrated performance in 3D positional accuracy with a mean error statistically significantly lower than 3mm and in trajectory angle accuracy with a mean error statistically significantly lower than 3 degrees, in phantom and cadayer studies,

. Performance of the Headset display was demonstrated by verifying the following elements: Field of View (FOV), resolution, luminance, transmission, distortion, contrast ratio, polarization, location of the virtual image plane and 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 ES60601-1:2005/(R)2012 and . A1:2012,C1:2009/(R)2012 and A2:2010/(R)2012 - 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 compatibility - Requirements and tests.
. Sterilization validation for the single use components was conducted in accordance with the ANSI AAMI ISO 11137-1:2006/(R)2010. Additionally, shelf life and packaging testing were performed to support the labeled shelf life. All tests were successfully completed.
. Reusable components were validated for cleaning, in accordance with the AAMI TIR30:2011 guidance, and for steam sterilization, in compliance with the partial cycle validation approach outlined in ANSI/AAMI/ISO 17665-1:2006/(R)2013 and the validation approach outlined in ANSI/AAMI/ISO 14937:2009/(R)2013.
. Headset cleaning and disinfection validation was performed according to AAMI TIR 30:2011/(R)2016, AAMI TIR 12:2010, and 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, June 16, 2016. All tests were successfully completed.
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 Spine System performs according to specifications and functions as intended.

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Conclusions

The xvision Spine System is substantially equivalent to the StealthStation S8 Spine Software V1.0.0. The xvision Spine has the same intended use and similar indications, technological characteristics, and principles of operation as its predicate device. 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 xvision Spine system functions as intended without raising new safety or effectiveness questions.

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).