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510(k) Data Aggregation

    K Number
    K955930
    Device Name
    BELTONE COMPOSER 2000 BTE HP
    Manufacturer
    BELTONE ELECTRONICS CORP.
    Date Cleared
    1996-03-01

    (71 days)

    Product Code
    ESD
    Regulation Number
    874.3300
    Type
    Traditional
    Panel
    Ear Nose & Throat
    Reference & Predicate Devices
    K933291
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    To amplify and transmit sound to the ear

    Device Description

    The Beltone Composer 2000 BTE HP Air Conduction Hearing Aid is identical to the Maico Gamma RD BTE HP programmable hearing aid (K933291) with the exception of changes to the labeling.

    AI/ML Overview

    I am sorry, but the provided text describes a hearing aid (Beltone Composer 2000 BTE HP) and its general features, technical characteristics, intended use, and assembly. It does not contain any information about a study, acceptance criteria, or performance metrics in the context of a clinical trial or evaluation.

    Therefore, I cannot provide the requested information about:

    1. A table of acceptance criteria and reported device performance.
    2. Sample size used for the test set or data provenance.
    3. Number and qualifications of experts for ground truth.
    4. Adjudication method for the test set.
    5. If an MRMC comparative effectiveness study was done or its effect size.
    6. If a standalone algorithm performance study 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 text focuses on establishing substantial equivalence to another hearing aid (Maico Gamma RD BTE HP programmable hearing aid, K933291) based on identical components and compliance with ANSI S3.22-1987 standards for technical specifications. This implies a different type of regulatory submission, likely a 510(k) in the US, where equivalence is demonstrated rather than new clinical trials with detailed performance metrics against specific acceptance criteria.

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