EXCEL AV STIM 1000 by EXCEL TECH. LTD.

I am sorry, but the provided text does not contain the acceptance criteria or a study proving that a device meets the acceptance criteria. The document is a clearance letter from the FDA for a device called "Excel AV Stim 1000" (later referred to as "Excel AV Stim 4000" in the Indications For Use section), stating that it is substantially equivalent to legally marketed predicate devices.

The document includes:

Trade Name: Excel AV Stim 1000 (and 4000)
Regulatory Class: II
Product Code: GWJ
Indications For Use: "AUDITORY TO PROVIDE VISUAL AND RECORDING FOR STIMULI EVOKED POTENTIAL S"

However, it does not provide any information about:

A table of acceptance criteria and reported device performance.
Sample size used for a test set or data provenance.
Number of experts used to establish ground truth or their qualifications.
Adjudication method for a test set.
A multi-reader multi-case (MRMC) comparative effectiveness study or its effect size.
Standalone performance of an algorithm.
The type of ground truth used.
Sample size for a training set.
How the ground truth for the training set was established.

Therefore, I cannot fulfill your request based on the provided text.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

In 30 1998

Mr. John R. Mumford President Excel Tech. Ltd. 2892 Portland Drive Oakville, Ontario CANADA, L6H 5W8

K972157 Re: Trade Name: Excel AV Stim 1000 Regulatory Class: II Product Code: GWJ Dated: November 17, 1997 Received: November 19, 1997

Dear Mr. Mumford:

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 requirements , as set forth in the Quality System Regulation (OS) 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

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Page 2 - Mr. Mumford

devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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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K972157A'

Page

510(k) Number (if known):K 972157 / Device Name:£XLEL AV STIM 4000

Indications For Use:

AUDITORY TO PROVIDE VISUAL AND RECORDING FOR STIMULI

EVOKED POTENTIAL S

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
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(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices
510(k) Number	K972157

Prescription Use (Per 21 CFR 801.109)	OR Over-The-Counter Use
	(Optional Format 1-2-96)

sk=67

Regulation Number and Section

§ 882.1900 Evoked response auditory stimulator.

(a)
Identification. An evoked response auditory stimulator is a device that produces a sound stimulus for use in evoked response measurements or electroencephalogram activation.(b)
Classification. Class II (performance standards).