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510(k) Data Aggregation

    K Number
    K991344
    Date Cleared
    1999-11-05

    (200 days)

    Product Code
    Regulation Number
    892.5730
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    WORLDWIDE MEDICAL TECHNOLOGIES SEEDING SPACERS

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

    The Worldwide Medical Technologies Seeding Spacers intended use is to provide space between radionuclide seeds during the introduction of radionuclide seeds into the body for Brachytherapy procedures. The anatomical site is typically the transperineal approach for radionuclide seed application in and around the prostate.

    Device Description

    Not Found

    AI/ML Overview

    This looks like an FDA 510(k) clearance letter and an 'Indications For Use' statement, not a study report. This type of document generally does not contain the information requested regarding acceptance criteria, device performance results, study design details, or ground truth establishment.

    A 510(k) clearance letter indicates that the FDA has found a device to be substantially equivalent to a predicate device already on the market, meaning it's as safe and effective as the predicate. It does not typically involve the submission of detailed performance studies against pre-defined acceptance criteria in the same way a Premarket Approval (PMA) would.

    Therefore, I cannot provide the requested information from the given input.

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