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510(k) Data Aggregation

    K Number
    K030761
    Device Name
    KAISHOU VAGINAL SPECULUM
    Manufacturer
    JIANGSU KAISHOU MEDICAL APPARATUS CO., LTD
    Date Cleared
    2003-06-09

    (90 days)

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

    The Kaishou Disposable Vaginal Speculum is intended to be used by a medical professional to expose the interior of the vaginal to facilitate visualization during gynecological or obstetrical procedures.

    Device Description

    Not Found

    AI/ML Overview

    I apologize, but the provided text does not contain information about acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies for the Kaishou Vaginal Speculum.

    The document is a 510(k) clearance letter from the FDA, stating that the device is substantially equivalent to legally marketed predicate devices. It focuses on regulatory compliance and the permission to market the device, rather than detailed performance study results.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input.

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