The SNT Stereotactic Localization System is indicated for providing a precise stereotactic coordinate system in either CT or Radiographic images for the purpose of planning and performing stereotactic cranial procedures.

Device Description

The system includes:

a headring .
a CT localizer ●
an X-ray localizer ●
a film holder ●

AI/ML Overview

This document, K971675, is a summary of safety and effectiveness for the SNT Stereotactic Localization System, a medical device cleared by the FDA in 1997. Due to the age and nature of the document (a 510k summary for a device without integrated AI), it does not contain the detailed information required for a modern AI-powered medical device submission's acceptance criteria and study design.

Specifically, the document is a 510(k) Pre-market Notification for substantial equivalence to devices marketed prior to May 28, 1976. This type of clearance primarily focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than providing rigorous clinical trial data or performance metrics in the way an AI/ML device would be evaluated today.

Therefore, it is not possible to extract the requested information regarding acceptance criteria, study details, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set sizes from the provided text.

The document only states: "The SNT Stereotactic Localization System was shown to be substantially equivalent to other commercially available stereotactic localization systems." This is the core "acceptance criteria" for a 510(k) submission of this type at that time. There is no performance metric, only substantial equivalence.

In summary, the provided text does not contain the information needed to answer your questions about acceptance criteria and study data in the context of an AI-powered medical device.

Summary

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Summary of Safety and Effectiveness

SNT Stereotactic Localization System JUL 1 4 1997

Surgical Navigation Technologies Company: 】. 530 Compton St. Broomfield, CO 80020 (303) 439-9709

Product Name: SNT Stereotactic Localization System II.
III. The SNT Stereotactic Localization System is indicated for providing a precise stereotactic coordinate system in either CT or Radiographic images for the purpose of planning and performing stereotactic cranial procedures.

The system includes:

a headring .
a CT localizer ●
an X-ray localizer ●
a film holder ●
I V. The SNT Stereotactic Localization System was shown to be substantially equivalent to other commercially available stereotactic localization systems.

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Image /page/1/Picture/1 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three heads facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the top half of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Roger N. White Surgical Navigation Technologies, Inc. 530.Compton Street JUL 1 4 1997 Broomfield, Colorado 80020

Re: K971675 Trade Name: SNT Stereotactic Localization System Regulatory Class: II Product Code: 84HAW Dated: May 5, 1997 Received: May 7, 1997

Dear Mr. White:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent to 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). You may, therefore, market the device, subject to the general controls provisions of the Act. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Pood and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Roger N. White

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in_vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

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510(k) Number (if known): K971475

Device Name: ________________________________________________________________________________________________________________________________________________________________

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office Of Device Evaluation (ODE)

Prescription Use_ (Per 21 CFR 801.109)

Over-The-Counter Use_

(Optional Format 1-2-96)

la(Division Sign-Off)

(Division Sign-Oit)
Division of Cardiovascular, Respiratory, Division of Size of Sical Devices 510(k) Number

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).