MICROMEDICS S&T TOTAL OSSICULAR REPLACEMENT PROSTHESIS AND ACCESSORIES by MICROMEDICS, INC.

I am sorry, but based on the provided document, I cannot describe the acceptance criteria and the study that proves the device meets them. The document is an FDA 510(k) clearance letter for the "S&T Total Ossicular Replacement Prosthesis" and primarily states that the device is substantially equivalent to legally marketed predicate devices.

The letter does not include:

A table of acceptance criteria or reported device performance.
Details about sample sizes, data provenance, or expert qualifications for a test set.
Information on adjudication methods.
Any multi-reader multi-case (MRMC) comparative effectiveness study results or effect sizes.
Standalone algorithm performance.
The type of ground truth used.
Training set sample size or how its ground truth was established.

This document is a regulatory approval notice, not a detailed technical report or study summary. Therefore, the requested information is not available in the provided text.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 9 1999

Mr. Charles Grote Manager of Quality Assurance and Regulatory Affairs Micromedics, Inc. 1285 Corporate Center Drive-#150 Eagan, MN 55121 USA

Re: K992138 Trade Name: S&T Total Ossicular Replacement Prosthesis Regulatory Class: II Product Code: ETA Dated: July 8, 1999 Received: July 9, 1999

Dear Mr. Grote:

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 (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. Charles Grote

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) 594-4613. 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,

A. Ralph Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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MICROMEDICS, INC. 510(K) Premarket Notification

510(K) Number: Not known at this time

KA92138

Device Name: S&T Total Ossicular Replacement Prosthesis

STATEMENT OF INDICATIONS FOR USE

For surgical reconstruction of the ossicular chain between the stapes footplate and ear drum where the stapes footplate is present and mobile.

(PLEASE 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
Krea Bohr

(Division Sign-Off) (Division of Ophthalmic Devices 510(k) Number

Regulation Number and Section

§ 874.3495 Total ossicular replacement prosthesis.

(a)
Identification. A total ossicular replacement prosthesis is a device intended to be implanted for the total functional reconstruction of the ossicular chain and facilitates the conduction of sound waves from the tympanic membrance to the inner ear. The device is made of materials such as polytetrafluoroethylene, polytetrafluoroethylene with vitreous carbon fibers composite, porous polyethylene, or from a combination of these materials.(b)
Classification. Class II.