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510(k) Data Aggregation

    K Number
    K972723
    Device Name
    BIO TROL
    Manufacturer
    MINDMEDIA LABS, INC.
    Date Cleared
    1997-10-02

    (73 days)

    Product Code
    HCC,APR
    Regulation Number
    882.5050
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Predicate For
    K142551
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Biofeedback is to be used for muscle re-education and relaxation training

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the detailed information needed to answer your request about the acceptance criteria and the study that proves the device meets them. The text is a 510(k) clearance letter from the FDA for a device named "BioTrol," indicating it's cleared for marketing.

    While it mentions the device's intended use (muscle re-education and relaxation training via biofeedback) and its classification, it does not include any details about:

    • Acceptance criteria: What specific performance metrics were set for the device.
    • Device performance: The actual results achieved by the device in testing.
    • Study design details:
      • Sample size for test set or training set.
      • Data provenance.
      • Number or qualifications of experts.
      • Adjudication methods.
      • MRMC studies or effect sizes.
      • Standalone algorithm performance.
      • Type of ground truth used or how it was established.

    This document is primarily an administrative clearance letter, not a technical report detailing the device's validation studies.

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