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510(k) Data Aggregation

    K Number
    K991399
    Device Name
    RADIONICS MICROELECTRODE KIT
    Manufacturer
    RADIONICS, INC.
    Date Cleared
    1999-09-21

    (152 days)

    Product Code
    GXI
    Regulation Number
    882.4725
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Predicate For
    K012850,K050084
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    For recording, stimulating and lesioning nervous tissue for functional neurosurgical procedures such as but not limited to: cordotomies, tractotomies, myelotomies, thalamotomies and pallidotomies.

    Device Description

    The above device consists of a recording electrode, sheath, adaptor bushing, spacer and passing cannula. It is used with the Nueromap System, CRW Stereotaxtic frame and lesion generator to record signals in determining the placement of lesions.

    AI/ML Overview

    The provided text does not contain information about acceptance criteria or a study that proves the device meets those criteria. This 510(k) summary (K991399) primarily addresses the substantial equivalence of the Radionics Microelectrode Kit (MEK) to a predicate device based on its intended use and technological characteristics.

    Therefore, I cannot provide the requested information, including:

    1. A table of acceptance criteria and the reported device performance: No such criteria or performance data are mentioned.
    2. Sample size used for the test set and the data provenance: No test set is described.
    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment is described.
    4. Adjudication method: Not applicable as there is no described test set.
    5. Multi-reader multi-case (MRMC) comparative effectiveness study: No such study is mentioned.
    6. Standalone (algorithm only without human-in-the-loop performance) study: This device is a physical electrode kit, not an algorithm.
    7. The type of ground truth used: Not applicable as there is no described test set.
    8. The sample size for the training set: This device is a physical electrode kit, not a machine learning model.
    9. How the ground truth for the training set was established: Not applicable.

    The submission focuses on basic device description, intended use, and comparison to a pre-amendments predicate device to demonstrate substantial equivalence, and not on performance studies with specific statistical endpoints or acceptance criteria.

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