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510(k) Data Aggregation

    K Number
    K973978
    Device Name
    MICRO II MICROCURRENT TENS
    Manufacturer
    APEX MEDICAL CORP.
    Date Cleared
    1998-07-29

    (282 days)

    Product Code
    GZJ
    Regulation Number
    882.5890
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This device is restricted to sale or use by or on the order of a physician licensed in the state in which he or she is practicing. It is to be used solely for the symptomatic relief of chronic intractable pain.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for a medical device called "MICRO-II MICROCURRENT TENS." This type of document is a regulatory approval, not a scientific study report. It states that the device is "substantially equivalent" to legally marketed predicate devices.

    Therefore, this document does not contain the information requested regarding:

    • Acceptance criteria and reported device performance.
    • Details of a study proving the device meets acceptance criteria.
    • Sample sizes, data provenance, number/qualifications of experts, adjudication methods.
    • Multi-reader multi-case (MRMC) comparative effectiveness study results.
    • Standalone algorithm performance.
    • Type of ground truth used or how it was established for training or testing.
    • Training set sample size.

    The document's purpose is to grant market clearance based on substantial equivalence, implying that the device performs similarly to existing, approved devices, rather than presenting novel performance data from a new study against explicit acceptance criteria.

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