The indications for use of the Guideline System 3000 MP-1 Micropositioner are for procedures where a precise placement of probes, such as those used for electrophysiological recording and stimulation, lesioning, or chronic stimulation within the nervous system is required.

Device Description

The MP-1 Micropositioner is a three-axis positioning device for precise manipulation of probes or electrodes in stereotactic neurosurgical procedures. The "x" and "y" axes are driven by simple micrometer screws, while the "z" or depth axis is driven by a motorized lead-screw arrangement. The positioner allows for the accurate placement of probes within the three dimensional stereotactic space once it has been mounted on a legally marketed stereotactic frame.

AI/ML Overview

The provided text describes the Guideline System 3000 MP-1 Micropositioner, a device for precise manipulation of probes in neurosurgical procedures. However, the document does not contain explicit acceptance criteria in a quantitative table or a detailed study proving the device meets specific performance metrics in the way a modern AI/device study would.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices. This regulatory approach, common for medical devices cleared through the 510(k) pathway, means that the device is deemed safe and effective if it has the same intended use and technological characteristics as a legally marketed predicate device, or if any differences do not raise new questions of safety or effectiveness.

Here's an analysis based on the provided text, addressing the requested information points where possible, and noting where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided document, a detailed table of quantitative acceptance criteria and specific reported device performance meeting those criteria, as one would expect for an AI algorithm's performance, is NOT available.

The document states: "The Guideline System 3000 MP-1 Micropositioner has been demonstrated to perform as intended with accuracy and repeatability. In accordance with our development plan, the Guideline System MP-1 Micropositioner has been extensively tested in both bench test and animal test conditions. Prototype instruments meet or exceed all appropriate Feature and Engineering Specifications and tolerances."

This general statement indicates that internal specifications and tolerances were met, but the specific numerical acceptance criteria (e.g., "accuracy of X mm with a standard deviation of Y mm") and the corresponding measured performance values are not disclosed in this summary.

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

This information is not provided in the document. The text mentions "extensively tested in both bench test and animal test conditions," but no specific sample sizes for these tests are given, nor is the data provenance (e.g., country of origin, retrospective/prospective nature) detailed.

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

This information is not applicable / not provided. This device is a mechanical instrument, not an AI diagnostic tool that requires ground truth established by human experts for interpretive tasks.

4. Adjudication Method for the Test Set

This information is not applicable / not provided. As above, this device's performance testing would not involve expert adjudication in the context of diagnostic interpretation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is specifically relevant for diagnostic AI tools where the goal is to evaluate if AI assistance improves human reader performance (e.g., in medical image interpretation). The MP-1 Micropositioner is a mechanical surgical instrument, not a diagnostic tool requiring human interpretation.

6. If a Standalone (Algorithm Only Without Human-in-the Loop Performance) Was Done

This question is not applicable in the context of this mechanical device. The performance of the MP-1 Micropositioner would be evaluated on its own mechanical precision and repeatability, not as an algorithm operating independently of human interaction. The "performance data" section states it "has been demonstrated to perform as intended with accuracy and repeatability," implying intrinsic device performance, but not in the sense of a standalone AI algorithm.

7. The Type of Ground Truth Used

For a mechanical device like the MP-1 Micropositioner, "ground truth" would refer to its physical measurements against a known standard or ideal. The document implies that testing involved:

Bench test conditions: This likely involved measuring the device's movement and positioning accuracy against calibrated standards.
Animal test conditions: This would involve using the device in a biological setting (animals) and likely assessing its ability to accurately place probes to specific anatomical targets.

The specific "type of ground truth" (e.g., specific measurement techniques, histological confirmation in animal studies) is not detailed in the provided text.

8. The Sample Size for the Training Set

This information is not applicable. The MP-1 Micropositioner is a mechanical device, not an AI system that undergoes "training" with a dataset.

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

This information is not applicable. As it's not an AI system, there is no training set or ground truth in that context.

Summary

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SUMMARY OF SAFETY AND EFFECTIVENESS

This 510(k) summary and saftey and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92.

SUBMITTER INFORMATION

Company Name:

Company Address:

Foster City, CA 94404

Axon Instruments, Inc.

1101 Chess Drive

Company Phone: Company Fax:

(650) 571-9400 (650) 571-9500

Contact Person:

Andrew Blatz, Ph.D. Regulatory Affairs Manager Product-Line Manager Neurosurgical Devices Axon Instruments, Inc.

Date Summary Prepared:

January 7, 1999

DEVICE IDENTIFICATION

Trade/Proprietary Name:

Guideline System 3000 MP-1 Micropositioner

Classification Name:

Stereotaxic Instruments and Accessories

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IDENTIFICATION OF PREDICATE DEVICE

Company	Device	510(k) No.	Date Cleared
Radionics	Brown-Roberts-WellsStereotaxic System	K811452	6/1/81
Radionics	Semi-Micro-Electrode Kit	Preamendmentdevice	Not applicable

DEVICE DESCRIPTION

SUBSTANTIAL EQUIVALENCE

The Guideline System 3000 MP-1 Micropositioner is substantially equivalent to the predicate devices. The intended use, labeling, physical characteristics, and safety features of the Guideline System MP-1 Micropositioner and the predicate devices are very similar, differing only in details that have no bearing on safety and effectiveness. The technologies involved in both the predicate devices and the Guideline System 3000 MP-1 Micropositioner are all time-tested, standard approaches and are listed in the comparison charts provided in this 510(k) submission.

INTENDED USE

The Guideline System 3000 MP-1 Micropositioner is intended for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.

TECHNOLOGICAL CHARACTERSTICS

A comparison of the technological characteristics of the MP-1 Micropositioner to the predicate and legally marketed devices is provided within this submission.

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PERFORMANCE DATA

The Guideline System 3000 MP-1 Micropositioner has been demonstrated to perform as intended with accuracy and repeatability. In accordance with our development plan, the Guideline System MP-1 Micropositioner has been extensively tested in both bench test and animal test conditions. Prototype instruments meet or exceed all appropriate Feature and Engineering Specifications and tolerances.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 3 1999

James C. Makous, Ph.D. Product Line Manager, Neurosurgical Devices Axon Instruments, Inc. 1101 Chess Drive Foster City, California 94404

Re: K990683 Trade Name: Axon MP-1 Micropositioner Regulatory Class: II Product Code: HAW Dated: August 4, 1999 Received: August 5, 1999

Dear Dr. Makous:

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 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 (OS) 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 - James C. Makous, Ph.D.

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,

Collie M. Wilson, Ph.D., M.P.

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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622 510(k) Number (if known):

Device Name: MP-1 Micropositioner

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

sedo

(Division Sign-Off)
Division of General Restorative Devices K99068)
510(k) Number

Prescription Use

Over-The-Counter Use _

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

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).