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    K Number
    K965057
    Device Name
    AUDIOTONE (A554H)
    Manufacturer
    MIRACLE-EAR, INC.
    Date Cleared
    1997-01-27

    (40 days)

    Product Code
    ESD
    Regulation Number
    874.3300
    Type
    Traditional
    Panel
    Ear Nose & Throat
    Reference & Predicate Devices
    K941122
    Why did this record match?
    Device Name :

    AUDIOTONE (A554H)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    To amplify and transmit sound to the ear.

    Device Description

    BTE Hearing Aid

    AI/ML Overview

    The provided document is a Summary of Safety and Effectiveness for the Audiotone A-554H BTE hearing aid, dated January 27, 1997. It outlines the device details, classification, intended use, and substantial equivalence to a previously cleared device (Audiotone A-54SR, K941122).

    However, the document does not contain any information regarding specific acceptance criteria, a study proving the device meets those criteria, or any details related to AI/algorithm performance, ground truth establishment, or sample sizes for training/test sets.

    Therefore, I cannot fulfill your request for the following sections based on the provided input:

    1. A table of acceptance criteria and the reported device performance
    2. Sample sized used for the test set and the data provenance
    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
    4. Adjudication method for the test set
    5. 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
    6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
    7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
    8. The sample size for the training set
    9. How the ground truth for the training set was established

    The document states: "Dahlberg utilizes the ANSI S3.22-1987 methodology to test and obtain performance data for hearing aids." This indicates adherence to an industry standard for performance evaluation, but the specifics of acceptance criteria (e.g., minimum gain, maximum output, harmonic distortion limits) and the results against those criteria are not detailed in this summary. The "Substantially Equivalent to" section implies that its performance is considered comparable to the A-54SR, which was previously cleared, suggesting it meets similar performance standards, but no data is presented within this document to demonstrate that directly.

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