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510(k) Data Aggregation

    K Number
    K961827
    Device Name
    IN-THE-EAR
    Manufacturer
    QUALITONE
    Date Cleared
    1996-07-03

    (51 days)

    Product Code
    ESD
    Regulation Number
    874.3300
    Type
    Traditional
    Panel
    Ear Nose & Throat
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Not Found

    Device Description

    The design follows traditional principles of operation for hearing aid instruments. This device is manufactured and assembled with equivalent manufacturing practices and performance guidelines. Performance of this instrument meets requirements specified by ANSI S-3.22 1987. User controls and methods are similar to other products currently on the market. Sound processing for this instrument is also similar to devices presently marketed by Qualitone.

    AI/ML Overview

    The provided text is a "Summary of Safety And Effectiveness" for a hearing aid device, K961827, from Qualitone, submitted in 1996. It states that the device is substantially equivalent to existing products and meets the requirements of ANSI S-3.22 1987.

    However, the document does not contain the detailed information requested regarding:

    1. Acceptance criteria and reported device performance in a table. It only broadly states "Performance of this instrument meets requirements specified by ANSI S-3.22 1987."
    2. Sample size used for the test set and data provenance.
    3. Number and qualifications of experts for ground truth.
    4. Adjudication method.
    5. Multi Reader Multi Case (MRMC) comparative effectiveness study information.
    6. Standalone (algorithm only) performance.
    7. Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
    8. Sample size for the training set.
    9. How the ground truth for the training set was established.

    The document is a regulatory submission summary focused on demonstrating substantial equivalence with existing devices based on traditional design principles, manufacturing practices, and adherence to a specific ANSI standard. It does not provide the results of a detailed study with the specific metrics requested.

    Therefore, I cannot populate the requested information from the provided text.

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