Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K033429
    Date Cleared
    2003-12-04

    (37 days)

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

    Advanced Neuromodulation Systems Lamitrode Spinal Cord Stimulation Leads are 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 and are intended to be used with Advanced Neuromodulation Systems extensions and/or, receivers, transmitters, and antennae.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves a device meets specific acceptance criteria.

    The document is a 510(k) clearance letter from the FDA for a device named "C-Series Lamitrode Spinal Cord Stimulation Leads". This letter is a regulatory document indicating that the FDA has determined the device is substantially equivalent to a legally marketed predicate device, allowing it to be marketed.

    It does not contain the kind of technical study data that would include:

    • A table of acceptance criteria and reported device performance.
    • Sample sizes for test sets, data provenance, or the number/qualifications of experts.
    • Adjudication methods.
    • Information about multi-reader multi-case (MRMC) studies or standalone algorithm performance.
    • Details on ground truth types or how ground truth was established for training sets.
    • Training set sample sizes.

    Therefore, I cannot provide the requested table and information as it is not present in the given text.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1