VECTORVISION SPINE MODULE by BRAINLAB, AG

BrainLAB VectorVision Spine Module is intended to be an intraoperative image guided localization system to enable open or percutaneous surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a patient's images data being processed by a BrainSCAN workstation (K915819). The system is indicated for any medical condition where a reference to a rigid anatomical structure, such as the skull, a long bone or vertebra can be identified relative to a C.I hased model of the anatomy where surgically appropriate.

Device Description

intraoperative image guided localization system to enable open or percutaneous surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a patient's images data being processed by a BrainSCAN workstation (K915819).

AI/ML Overview

This document is a 510(k) clearance letter for the BrainLAB VectorVision Spine system. It indicates FDA clearance for marketing but does not contain detailed information about acceptance criteria or specific study results that prove the device meets those criteria. Such information is typically found in the 510(k) summary or the full submission, which is not provided here.

Therefore,Based on the provided document (FDA 510(k) clearance letter for BrainLAB VectorVision Spine), the detailed information requested regarding acceptance criteria and a study proving device performance is not available.

This document is a regulatory approval letter, indicating that the device has been found substantially equivalent to a predicate device. It does not contain the technical details of performance studies or acceptance criteria that would typically be found in a 510(k) summary or the full submission.

Therefore, for each of your points, the answer is:

A table of acceptance criteria and the reported device performance: Not provided in this document.
Sample size used for the test set and the data provenance: Not provided in this document.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided in this document.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not provided in this document.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not provided in this document. The device is an image-guided localization system, not an AI-assisted diagnostic tool for human readers in the context of MRMC studies.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not provided in this document. The device is described as an "intraoperative image guided localization system to enable open or percutaneous surgery," which implies human interaction.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not provided in this document.
The sample size for the training set: Not provided in this document.
How the ground truth for the training set was established: Not provided in this document.

To obtain this information, one would typically need to review the full 510(k) submission or the 510(k) summary if it were publicly available and detailed enough.

Summary

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 9 1998

Mr. Stefan Vilsmeier President BrainLAB USA, Inc. 3100 Hansen Way Building 4A, Mailstop E233 Palo Alto, California 94304

Re: K981508 VectorVision Spine Trade Name: Regulatory Class: II Product Code: HAW Dated: August 06, 1998 Received: August 10, 1998

Dear Mr. Vilsmeier:

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 (for the indications for use stated in the enclosure) 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 Requlations, Title 21, Parts 800 to 895. ಗಿ 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 Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory 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. Stefan Vilsmeier

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) 594-4595. 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,

Celia M. Witten, Ph.D., M.D.
Director

Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page l of I

510(k) Number (if known):	K981508
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Vector Vision Spine Device Name:

Indications For Usc:

(I'LEASE 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)	OR	Over-The-Counter Use(Optional Format 1-2-96)
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(Division Sign-Off)

Division of General Restorative Devices
510(k) Number K981508GESAMT SEITEN 02

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).