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510(k) Data Aggregation

    K Number
    K041953
    Device Name
    VERSASTIM, PERFOAMAX, SURGI-STIM, FASTSTART
    Manufacturer
    CONMED CORP.
    Date Cleared
    2004-08-09

    (20 days)

    Product Code
    GXY
    Regulation Number
    882.1320
    Type
    Special
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    VERSASTIM, PERFOAMAX, SURGI-STIM, FASTSTART

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

    For TENS and Neuromuscular Stimulation

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text from the FDA letter and attachment does not contain information regarding the acceptance criteria for a medical device and the study that proves the device meets those criteria. The documents are a formal FDA communication about a 510(k) clearance for the ConMed™ VersaStim Neuromuscular Stimulator/TENS and its electrodes.

    Specifically, the documents include:

    • A letter granting 510(k) clearance, indicating the device is substantially equivalent to legally marketed devices.
    • Information about regulatory requirements and general controls.
    • An "Indications for Use" statement for the device.

    There is no mention of:

    • Specific acceptance criteria (e.g., performance metrics, thresholds).
    • A study design or methodology.
    • Sample sizes for test or training sets.
    • Data provenance.
    • Details about expert ground truth establishment or adjudication.
    • Multi-Reader Multi-Case (MRMC) studies or their outcomes.
    • Standalone algorithm performance.
    • Type of ground truth used (pathology, expert consensus, etc.).

    Therefore, I cannot fulfill your request for a table of acceptance criteria, device performance, or details about a study, as this information is not present in the provided text.

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