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510(k) Data Aggregation

    K Number
    K992186
    Device Name
    QUAD BIPOLAR LAPAROSCOPIC COAGULATING AND CUTTING INSTRUMENT
    Manufacturer
    CONMED CORP.
    Date Cleared
    1999-07-30

    (31 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    For use in laparoscopic and open surgical procedures to provide r of ass iral cutting and electrosurgical hemostasis of tissue as well as grasping and manipulation of the tissue.

    Device Description

    ConMED QUAD™ Bipolar Laparoscopic Coagulating and Cutting Instrument

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (ConMed QUAD Bipolar Laparoscopic Coagulating And Cutting Instrument). This document primarily focuses on regulatory approval and does not contain the detailed technical or clinical study information required to answer your specific questions about acceptance criteria, device performance, study design, or ground truth establishment.

    Specifically, the document does not include:

    1. A table of acceptance criteria and reported device performance.
    2. Information on sample sizes, data provenance, number of experts for ground truth, adjudication methods, or ground truth types for a test set.
    3. Details about a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or human reader improvement with AI.
    4. Information about standalone algorithm performance.
    5. Details on training set size or how ground truth for the training set was established.

    This document confirms substantial equivalence to a predicate device based on the indications for use, but it does not provide the technical studies or clinical trial results that would typically contain the information you are requesting.

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