FRAMELESS NEUROMATE by INTEGRATED SURGICAL SYSTEMS, INC.

Stereotactic spatial positioning and orientation of an instrument holder or tool guide to be used by a surgeon to manually guide standard neurosurgical instruments.

Device Description

A stereotactic system with an electromechanical, multijointed arm for spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a preoperative plan developed with three-dimensional imaging software and utilizes ultrasonic registration. The system is intended for use by neurosurgeous to guide standard neurosurgical instruments.

AI/ML Overview

The provided text is a 510(k) summary for the Frameless NeuroMate Stereotactic System. It focuses on establishing substantial equivalence to a predicate device rather than presenting a study demonstrating the device meets specific performance acceptance criteria. Therefore, most of the requested information cannot be extracted directly from this document.

Here's what can be gathered and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not specified	Not specified

Explanation: The document does not provide specific quantitative acceptance criteria or corresponding performance data for the device itself. It primarily states that the device has "no substantive change in materials, basic components, or method of manufacture" compared to the predicate, and that the registration system is "similar to that currently used in other medical devices." It also mentions "commercially available imaging software for stereotactic planning, which has been developed, verified and validated to applicable standards, and guidance documents." These are general statements of compliance or similarity, not specific performance metrics.

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

Sample Size: Not specified.
Data Provenance: Not specified (retrospective or prospective, country of origin).

Explanation: No clinical or performance study with a test set is described.

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

Number of Experts: Not applicable.
Qualifications of Experts: Not applicable.

Explanation: No test set or ground truth establishment is described.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable.

Explanation: No test set or adjudication process is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

MRMC Study: No.
Effect Size of Human Readers Improvement with AI vs. without AI assistance: Not applicable.

Explanation: The document describes a medical device for surgical guidance, not an AI-assisted diagnostic tool that would typically undergo an MRMC study.

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

Standalone Study: No.

Explanation: The device is a stereotactic system intended for use by neurosurgeons to manually guide instruments. Its function inherently involves human interaction, and there's no mention of a standalone algorithm performance measurement.

7. The Type of Ground Truth Used

Type of Ground Truth: Not applicable.

Explanation: Since no performance study is detailed, no ground truth is described.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable.

Explanation: The device involves "imaging software for stereotactic planning," which is stated to be "commercially available" and "developed, verified and validated to applicable standards." However, there is no mention of a separate "training set" or "algorithm training" in the context of this 510(k) submission. The focus is on the substantial equivalence of the overall system and its components.

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

Ground Truth Establishment for Training Set: Not applicable.

Explanation: As no training set or specific algorithm training is detailed in this document, the method for establishing its ground truth is not provided.

Summary

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JUN 25 1999

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K991081/

SUMMARY OF SAFETY AND EFFECTIVENESS

Frameless NeuroMate DEVICE NAME (Trade, common, and classification): 1.0 Stereotactic System.
PREDICATE DEVICE(s): K963256. 2.0
DESCRIPTION: A stereotactic system with an electromechanical, multijointed arm 3.0 for spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a preoperative plan developed with three-dimensional imaging software and utilizes ultrasonic registration. The system is intended for use by neurosurgeous to guide standard neurosurgical instruments.
4.0 USE: A computer-controlled image-guided electromechanical INTENDED multijointed arm, intended to be used in a neurosurgical operating room for the stereotactic spatial positioning and orientation of an instrument holder or tool guide to be used by the surgeon to manually guide standard neurosurgical instruments, under a surgeon-developed, carefully prepared stereotactic treatment plan.
INDICATION FOR USE: Stereotactic spatial positioning and orientation of an રું રા instrument holder or tool guide to be used by a surgeon to manually guide standard neurosurgical instruments.
BASIS OF REQUEST: The following factors are the basis of our request for a 6.0 finding of substantial equivalency:
- No substantive change in materials, basic components, or method of 6.1 manufacture between this device and the predicate device; the system and its components have been used in the medical device industry for similar or identical products and for similar or identical uses with no record of any patient problems, adverse reactions;
- 6.2 No change in basic construction;

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The device and its components have been tested by independent labs for EMC 6.3. and safety, EU standards compliance, and will be subjected to inspection and testing at IQA, and during/after manufacture and upon installation in the field; and
The function and use of this product will be no different than that of predicate 6.4. devices and other similar devices currently in the marketplace.
7.0 No substantive differences exist between the SUBSTANTIVE DIFFERENCES: product defined in this 510(k) submission and the predicate device, except the registration system, which is similar to that currently used in other medical devices, and the incorporation of a commercially available imaging software for stereotactic planning, which has been developed, verified and validated to applicable standards, and guidance documents, cited herein.

Signed: ___ Dated: 3/29/99

RD Hibbert Director of Clinical and Regulatory Affairs Integrated Surgical Systems, Inc. 1850 Research Drive Davis, CA 95616 Fax: 530-792-2690 Phone: 530-792-2621

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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 is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles three human profiles facing to the right, with wavy lines extending from the bottom of the profiles.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 25 1999

Mr. R. D. Hibbert Director Clinical and Regulatory Affairs Integrated Surgical Systems 1850 Research Park Drive Davis. California 95616

Re: K991081

Trade Name: Frameless NeuroMate Stereotactic System Regulatory Class: II Product Code: HAW Dated: March 29, 1999 Received: March 31, 1999

Dear Mr. Hibbert:

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 (OS) 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. R. D. Hibbert

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,

Cella 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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510(k) Number (if known):

Device Name: Frameless NeuroMate

Indications For Use:

Stereotactic spatial positioning and orientation of an instrument holder or tool guide to be used by a surgeon to manually guide standard neurosurgical instruments.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

Prescription Use_xx (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Formst 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).