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510(k) Data Aggregation

    K Number
    K964683
    Device Name
    DIGIFOCUS ITE
    Manufacturer
    OTICON, INC.
    Date Cleared
    1996-12-12

    (20 days)

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

    DIGIFOCUS ITE

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

    To amplify and deliver sound to the ear

    Device Description

    DigiFocus is a seven band, two channel fully automatic hearing instrument which utilizes true digital signal processing (DSP). True DSP allows for precise, seven band frequency shaping and a unique and complex compression system utilizing syllabic compression in the lower frequency channel (below 1500 Hz) and nonsyllabic compression in the higher frequency channel (above 1500Hz). 42 dB HFA gain. Assembled from standard electronic hearing aid components mounted together with custom microchips on flexfilm.

    AI/ML Overview

    It appears the provided text is a summary of safety and effectiveness information for a hearing aid device called "DigiFocus ITE (DFI)". However, the information details the device's technical specifications, intended use, and features but does not contain any information about acceptance criteria, study data, or performance outcomes.

    Therefore, I cannot provide the requested information, as the provided text lacks the necessary content to answer questions regarding:

    1. A table of acceptance criteria and reported device performance.
    2. Sample size and data provenance for a test set.
    3. Number and qualifications of experts for ground truth.
    4. Adjudication method for a test set.
    5. Multi-reader multi-case (MRMC) comparative effectiveness study or its effect size.
    6. Standalone performance.
    7. Type of ground truth used.
    8. Sample size for the training set.
    9. How ground truth for the training set was established.

    The text focuses on the device's technical characteristics and how it functions as a hearing aid, rather than a clinical study evaluating its performance against specific acceptance criteria.

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