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    K Number
    K960637
    Device Name
    5MM ENDOSCOPE
    Manufacturer
    ORIGIN MEDSYSTEMS, INC.
    Date Cleared
    1996-06-14

    (121 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    5MM ENDOSCOPE

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

    The 5mm Endoscope shares the same intended use as the predicate device. The 5mm Endoscope is a rigid endoscope which may be used to visualize the interior of body cavity or surgical working cavity during endoscopic procedures. The endoscope may also be used in conjunction with surgical devices which accept a 5mm diameter endoscope as their visualization component.

    Device Description

    The 5mm Endoscope is a rigid endoscopic device which is comprised of a shaft, scope body, illuminator port, eyepiece, light fiber optics, image rod, and front window. The 5mm Endoscope is a rigid endoscope which may be used to visualize the interior of body cavity or surgical working cavity during endoscopic procedures. The endoscope may also be used in conjunction with surgical devices which accept a 5mm diameter endoscope as their visualization component.

    AI/ML Overview

    I am sorry, but the provided text describes a 5mm Endoscope, a rigid endoscopic device, and its comparison to a predicate device. It does not contain any information about acceptance criteria, device performance, a study, or any of the other specific data points you requested (e.g., sample size, ground truth, expert qualifications, MRMC study, standalone performance, training set details).

    Therefore, I cannot fulfill your request for a table of acceptance criteria and device performance, or any of the other details about a study, as this information is not present in the given input.

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