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510(k) Data Aggregation

    K Number
    K050887
    Device Name
    GONGDONG DISPOSABLE VAGINAL SPECULUM
    Manufacturer
    ZHEJIANG GONGDONG MEDICAL PLASTIC FACTORY
    Date Cleared
    2005-07-11

    (95 days)

    Product Code
    HIB
    Regulation Number
    884.4530
    Type
    Abbreviated
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Predicate For
    K092870,K130046
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Gongdong Disposable Vaginal Speculum is non sterile products and is intended to be used by a medical professional to expose the interior of the vagina to facilitate visualization during the obstetrical and gynecological procedures.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) clearance letter from the FDA for a "Gongdong Disposable Vaginal Speculum," indicating its substantial equivalence to a predicate device. It specifies general controls, regulatory class, and indications for use.

    Therefore, I cannot provide the requested information, including tables of acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

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