Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K012644
    Date Cleared
    2002-07-29

    (350 days)

    Product Code
    Regulation Number
    876.1500
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Reprocessed Trocars and Cannulas are intended to open and maintain a port of entry during endoscopic procedures.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain information about explicit acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) clearance letter from the FDA, confirming that certain reprocessed endoscopic/laparoscopic trocars and cannulas are substantially equivalent to legally marketed predicate devices.

    While the letter mentions "supplemental validation data" was reviewed, it does not describe the specific acceptance criteria for that validation or the details of the study itself. It primarily focuses on the regulatory outcome (substantial equivalence) rather than the technical performance data.

    Therefore, I cannot populate the table or answer the specific questions about sample size, ground truth, expert qualifications, or study design based on the provided text.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1