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510(k) Data Aggregation

    K Number
    K974117
    Device Name
    PELVX DONUT, PELVX CUBE
    Manufacturer
    DESCHUTES MEDICAL PRODUCTS, INC.
    Date Cleared
    1998-04-27

    (178 days)

    Product Code
    HHW
    Regulation Number
    884.3575
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    PELVX DONUT, PELVX CUBE

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

    The PelvX Donut Vaginal Pessary is a vaginal pessary intended for support of 310 degree prolapse.

    The PelvX Cube Vaginal Pessary is a vaginal pessary intended for support of 314 degree prolapse combined with rectocele and/or cystocele.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for the PelvX Donut and PelvX Cube Vaginal Pessaries. This document does not contain information about acceptance criteria or a study proving the device meets those criteria, as it is related to regulatory approval based on demonstrating substantial equivalence to a predicate device, not performance testing of an AI/ML device.

    Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, study details, ground truth, or training sets from this document. The questions you've asked are typically relevant to the evaluation of AI/ML-driven diagnostic or assistive devices, which is not what this document describes.

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