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510(k) Data Aggregation

    K Number
    K150023
    Device Name
    Vertessa Lite Y-Mesh
    Manufacturer
    CALDERA MEDICAL, INC.
    Date Cleared
    2015-04-06

    (90 days)

    Product Code
    OTO
    Regulation Number
    878.3300
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    K123028
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Vertessa® Lite Y-Mesh may be used a bridging material for as sacrocolposuspension/sacrocolpopexy (laparotomy; laparoscopic, or robotically-assisted approach) where surgical treatment for vaginal vault prolapse is warranted.

    Device Description

    Vertessa® Lite Y-Mesh devices are designed to be used in women suffering from uterine or vaginal vault prolapse and are implanted or affixed using suture of the surgeon's choice. Vertessa® Lite Y-Mesh devices are provided sterile and are comprised of macroporous monofilament polypropylene warp knit clear mesh. Vertessa® Lite Y-Mesh will be available in a y-shape design of five different sizes (22 x 4 x 3 cm, 22 x 4 x 4 cm, 22 x 5 x 4 cm, 26 x 4 x 3 cm, 26 x 5 x 4 cm).

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) summary for a medical device (surgical mesh). It does not describe a study involving an AI or an algorithm, nor does it present acceptance criteria or performance data in the context of an AI device.

    Therefore, I cannot extract the information requested regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

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