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    K Number
    K151889
    Device Name
    Infinity ERCP Sampling Device
    Manufacturer
    UNITED STATES ENDOSCOPY GROUP, INC.
    Date Cleared
    2015-07-30

    (20 days)

    Product Code
    FDX
    Regulation Number
    876.1500
    Type
    Special
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Infinity ERCP Sampling Device

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

    The Infinity® ERCP sampling device is intended to retrieve cytological cell samples in the gastrointestinal tract.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is an FDA 510(k) clearance letter for the Infinity ERCP Sampling Device. It states that the device is substantially equivalent to legally marketed predicate devices and is intended to retrieve cytological cell samples in the gastrointestinal tract.

    However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or any of the other specific details requested in the prompt.

    Therefore, I cannot fulfill your request for a table of acceptance criteria and device performance, or details about the study that proves the device meets those criteria, as this information is not present in the provided text.

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