MAICO MA52 by BERNAFON-MAICO, INC.

The provided documents are a 510(k) clearance letter and an Indications For Use statement for the Maico MA52 device. These documents do not contain information about acceptance criteria, device performance studies, or details regarding ground truth establishment, expert qualifications, or sample sizes.

The 510(k) clearance letter (Document 0) states that the FDA has reviewed the submission and determined that the Maico MA52 is "substantially equivalent" to devices marketed prior to May 28, 1976. This determination indicates that the device met the regulatory requirements for showing substantial equivalence to a predicate device, but it does not delve into the specifics of performance criteria or clinical study results for the device itself.

The "Indications For Use" statement (Document 1) simply specifies that the device "would be for the detection and diagnosis of a suspected hearing loss."

Therefore, based on the provided text:

A table of acceptance criteria and the reported device performance: This information is not available in the provided documents.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not available.
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): Not available.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not available.
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: Not available. The device is an audiometer, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not available. The device is an audiometer, which typically involves a human operator.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not available.
The sample size for the training set: Not available.
How the ground truth for the training set was established: Not available.

Summary

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN -6 1997

Scott Savre Engineering Manager Bernafon-Maico, Inc. 9675 West 76th Street Eden Prairie, MN 55344 Re: K971080 Maico MA52 Dated: March 21, 1997 Received: March 25, 1997 ... Regulatory class: II 21 CFR 874.1050/Procode: 77 EWO

Dear Mr. Savre:

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 ensoment date of the Medical Device Amendances that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmelic 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 III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device and in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you might have under sections 51 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations,

This letter will allow you to begin marketing your device in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predication 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) 594-4591 for Radiology devices, or 594-4613 for Ear, Nose and Throat devices. 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,

William

Lillian Yin, Ph.D. Director, Division of Reproductive. Abdominal. Ear. Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1 -

510(k) Number (if known): K971080

Device Name:__________________________________________________________________________________________________________________________________________________________________ Maico MA52

Indications For Use:

The indications for use of the audiometer in this submission would be for the detection and diagnosis of a suspected hearing loss. ..

(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
(Optional Format 1-2-96)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K971080

Regulation Number and Section

§ 874.1050 Audiometer.

(a)
Identification. An audiometer or automated audiometer is an electroacoustic device that produces controlled levels of test tones and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders.(b)
Classification. Class II. Except for the otoacoustic emission device, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, if it is in compliance with American National Standard Institute S3.6-1996, “Specification for Audiometers,” and subject to the limitations in § 874.9.