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510(k) Data Aggregation

    K Number
    K033757
    Date Cleared
    2004-01-30

    (60 days)

    Product Code
    Regulation Number
    882.5880
    Reference & Predicate Devices
    N/A
    Predicate For
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Advanced Neuromodulation Systems, MTSm Multiprogram Trial Stimulator System is indicated for the treatment of chronic pain of the trunk and limbs, either as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach.

    The MTSm Multiprogram Trial Stimulator System is intended to be used with ANS Trial Leads (percutaneous) and External Test Extensions, to deliver targeted paresthesia to single or multiple painful sites for trial stimulation either intraoperatively or post operatively for up to a maximum of thirty days.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text focuses on an FDA 510(k) clearance letter for a medical device (MTS Multiprogram Trial Stimulation System) and does not contain information about the device's acceptance criteria, performance studies, or related data. The letter primarily confirms that the device has been found substantially equivalent to a legally marketed predicate device.

    Therefore, I cannot extract the requested information regarding:

    1. A table of acceptance criteria and reported device performance
    2. Sample size and data provenance for the test set
    3. Number and qualifications of experts for ground truth
    4. Adjudication method for the test set
    5. MRMC comparative effectiveness study results
    6. Standalone performance study
    7. Type of ground truth used
    8. Sample size for the training set
    9. Method for establishing ground truth for the training set
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