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510(k) Data Aggregation

    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
    Ear Nose & Throat
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MAICO MA42

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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.

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