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510(k) Data Aggregation

    K Number
    K151790
    Device Name
    PMT Platinum Depthalon Depth Electrode
    Manufacturer
    PMT CORPORATION
    Date Cleared
    2016-07-14

    (379 days)

    Product Code
    GZL
    Regulation Number
    882.1330
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    PMT Platinum Depthalon Depth Electrode

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

    The Platinum Depthalon® Depth Electrodes are intended for temporary (

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a medical device called "PMT Platinum Depthalon Depth Electrodes". This document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

    The letter is a regulatory document confirming that the device is substantially equivalent to legally marketed predicate devices. It discusses:

    • The device name and regulation number.
    • The indication for use of the device.
    • General controls provisions and other compliance requirements for the manufacturer.
    • Contact information for FDA divisions.

    Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based on the provided text.

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