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510(k) Data Aggregation

    K Number
    K010931
    Date Cleared
    2001-04-09

    (12 days)

    Product Code
    Regulation Number
    878.3300
    Reference & Predicate Devices
    Why did this record match?
    Device Name :

    AMS SACRAL COLPOPEXY SLING, MODEL 72403501

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

    The AMS Silicone-Coated Sling and Surgical Mesh is an implant that is intended for the treatment of urinary incontinence resulting from urethral hypermobility or ISD and for implantation to reinforce soft tissues where weakness exists in the urological, gynecological or gastroenterological anatomy. This includes, but is not limited to the following procedures: pubourethral support and bladder support, urethral and vaginal prolapse repair, colon and rectal prolapse repair, reconstruction of the pelvic floor and sacralcolposuspension.

    Device Description

    The AMS Sacral Colpopexy Sling is an alternate version of the AMS Silicone-Coated Sling and Surgical Mesh. The two slings are exactly the same except for the fact that the Sacral Colpopexy Sling is in the shape of a Y.

    AI/ML Overview

    I am sorry, but based on the provided text, the document is a 510(k) premarket notification letter from the FDA regarding a medical device called "AMS Silicone-Coated Sling and Surgical Mesh."

    This document does not contain information about acceptance criteria for a device's performance, nor does it describe a study to prove that the device meets such criteria. Instead, it is an FDA communication regarding the substantial equivalence of the device to legally marketed predicate devices, focusing on regulatory aspects rather than detailed performance study results from the manufacturer.

    Therefore, I cannot extract the requested information (table of acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, ground truth types, training set size, and ground truth establishment for training set) from this document.

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