MAICO MA42

• K Number: K982723
• Device Name: MAICO MA42
• Manufacturer: BERNAFON-MAICO, INC.
• Date Cleared: 1998-10-28 ( 84 days)
• Product Code: EWO
• Regulation Number: 874.1050
• Type: Traditional
• Panel: EN
• Reference & Predicate Devices: N/A

Intended Use

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

Device Description

Not Found

AI/ML Overview

This is a medical device approval letter from the FDA to Bernafon-Maico, Inc. regarding their Maico MA42 audiometer. The letter states that the device is substantially equivalent to devices marketed prior to May 28, 1976, and can therefore be marketed.

However, the provided text does not contain any information about acceptance criteria or a study proving the device meets those criteria. It is a regulatory approval document confirming substantial equivalence, not a detailed technical report on performance or testing.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method for the test set
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
6. If a standalone (algorithm only) performance was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

The document focuses solely on the regulatory approval process based on substantial equivalence, and does not delve into the specific performance metrics or studies you're asking for.

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.