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510(k) Data Aggregation

    K Number
    K983597
    Device Name
    NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODES
    Manufacturer
    MEDICOTEST, INC.
    Date Cleared
    1999-01-11

    (90 days)

    Product Code
    GXZ
    Regulation Number
    882.1350
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODES

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

    Recording muscle activity for Electromyography (EMG) applications. For single patient use only.

    Device Description

    Neuroline Disposable Monopolar Needle Electrode

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for a device called "Neuroline Disposable Monopolar Needle Electrode." This document primarily focuses on the regulatory clearance of a physical medical device, not an AI/software device.

    The questions you've asked are specifically designed for the evaluation of AI-powered medical devices, requiring information about acceptance criteria, performance studies, ground truth establishment, training sets, and human-in-the-loop performance.

    Therefore, based on the provided document, I cannot answer any of the questions about acceptance criteria or study details, as this information is not present nor relevant for a 510(k) clearance of a disposable needle electrode.

    The document states:

    • Trade Name: Neuroline Disposable Monopolar Needle Electrode
    • Regulatory Class: II
    • Product Code: GXZ
    • Indications For Use: Recording muscle activity for Electromyography (EMG) applications. For single patient use only.

    This indicates a physical medical instrument used to record electrical activity from muscles, which does not involve algorithms, AI, or software for its primary function.

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