The FHC microTargeting® Drive System is intended to be used with commercially available stereotactic systems for neurosurgical procedures which require the accurate positioning of microelectrodes, stimulation electrodes, or other instruments in the brain or nervous system.

Device Description

The microTargeting® Drive System with permits the accurate positioning of microelectrodes, stimulation electrodes, lesion electrodes, biopsy probes and other instruments in the brain and nervous system and is adaptable to all major stereotactic systems. The current microTargeting® Drive System allows the user to add position display capability or add power assist and position display capabilities.

AI/ML Overview

This 510(k) summary (K011992) for the FHC microTargeting® Drive System describes a device for accurate positioning of instruments in neurosurgical procedures. However, it does not contain the level of detail regarding acceptance criteria or a specific study proving the device meets those criteria, as requested in the prompt.

Therefore, I cannot provide quantitative information for most of your questions. The document focuses on demonstrating substantial equivalence to a legally marketed predicate device (K003776), rather than presenting a performance study with detailed acceptance criteria and results.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

Cannot be provided. The document does not specify quantitative acceptance criteria (e.g., accuracy thresholds, precision ranges) or present a table of reported device performance against such criteria. The substantial equivalence argument relies on the previous device's established performance without detailing it here.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Cannot be provided. The document does not describe a "test set" in the context of device performance evaluation. It refers to "differences that exist between these devices, relating to technical specifications, physical appearance, and design," but does not mention specific testing data, sample sizes, or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Cannot be provided. There is no mention of a "test set" requiring ground truth establishment by experts in this document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Cannot be provided. Not applicable as no test set or expert ground truth establishment is described.

5. 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

Cannot be provided. This device is a mechanical stereotactic drive system, not an AI-assisted diagnostic or therapeutic tool for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or described.

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

Cannot be provided. This is a mechanical device, not an algorithm. Standalone performance as typically understood for AI algorithms is not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Cannot be provided. No ground truth establishment is described in the context of device performance.

8. The sample size for the training set

Cannot be provided. No training set is mentioned as this is a mechanical device, not a machine learning algorithm.

9. How the ground truth for the training set was established

Cannot be provided. Not applicable as no training set or ground truth for it is mentioned.

Summary of available information related to the prompt:

Device Name: microTargeting® Drive System
Predicate Device: FHC, Inc microTargeting® Drive System (K003776), cleared Feb. 23, 2001.
Demonstration of Effectiveness: The summary asserts that the device is "substantially equivalent" to its predicate. The phrase "Differences that exist between these devices, relating to technical specifications, physical appearance, and design do not affect the relative safety and effectiveness of the microTargeting® Drive System" implies that the company believes any changes do not negatively impact the device's performance, but no new studies are cited to prove this in a quantitative manner within this document. The effectiveness is assumed to be similar to the predicate based on technical and design comparisons, not new performance data.

Summary

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KO11992

AUG 1 4 2001

510(k) SUMMARY of SAFETY and EFFECTIVENESS

FHC, Inc.

9 Main Street

207-666-8190

Frederick Haer

June 6, 2001

1226598

Bowdoinham, ME 04008

A. General Information

1. Submitter's Name:

Address:
Telephone Number:
Contact Person:
Date Prepared:
Registration Number:

B. Device
1. Name:

Trade Name:

1. Common Name:

Classification Name:
Product Code:
Class:
Regulation Number:

microTargeting® Drive System microTargeting® Drive System Stereotactic microdrive system Stereotactic Instrument HAW ll

882.4560

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C. Identification of Legally Marketed Devices

Name	K Number	Date Cleared
1. FHC, Inc microTargeting® Drive System	K003776	Feb. 23, 2001

D. Description of Device

E. Intended Use Statement

F. Technological Characteristics Summary

The FHC microTargeting® Drive System is substantially equivalent to the previously marketed FHC microTargeting® Drive System (K003776).

Differences that exist between these devices, relating to technical specifications, physical appearance, and design do not affect the relative safety and effectiveness of the microTargeting® Drive System.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

AUG 1 4 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Frederick Haer President and Chief Executive Officer FHC, Inc. 9 Main Street Bowdoinham, Maine 04008

Re: K011992

Trade/Device Name: microTargeting® Drive System Regulation Number: 882.4560 Regulatory Class: II Product Code: HAW Dated: July 25, 2001 Received: July 26, 2001

Dear Mr. Haer:

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 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). 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 requirements, 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 regulation 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. Frederick Haer

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 If you desire specific daires diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, (301) 594-1639. Tracklessf Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small monifacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Ro. Mark A. Mellikson

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation

Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): Kc) / 992

Device Name: microTargeting® Drive System

Indications For Use: The FHC microTargeting® Drive System is intended to be used with commercially available stereotactic systems for neurosurgical procedures which require the accurate ncaroourg.our provelectrodes, stimulating electrodes, or other pooltioning in the brain or nervous system.

(Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark N Melkener

General, Restorative and Neurological Devices

K 011992 510(k) Number _

(Optional Format 3-10-98)

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).