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510(k) Data Aggregation

    K Number
    K071902
    Device Name
    AMS MINIARC SLING SYSTEM
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Date Cleared
    2007-08-24

    (45 days)

    Product Code
    PAH
    Regulation Number
    878.3300
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K070065
    Why did this record match?
    Reference Devices :

    K070065

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

    The AMS MiniArc Sling System is intended for the placement of a suburethral sling for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

    Device Description

    The AMS MiniArc Sling System is a modification of Single Incision Sling System consisting of a sling and a surgical instrument (called a "Needle Passer") for suburethral sling placement. The slings are made from polymeric mesh.

    AI/ML Overview

    The provided text describes a 510(k) submission for the AMS MiniArc™ Sling System, a surgical mesh device for treating female stress urinary incontinence. However, it does not contain any information about acceptance criteria, device performance metrics, or a study to prove these criteria.

    The document is primarily focused on:

    • Identifying the submitter, contact person, device name, classification, and predicate device.
    • Stating the intended use of the device.
    • Briefly describing the device as a modification of a previous system.
    • Confirming that the device components were tested for biocompatibility and performance requirements and found "substantially equivalent to the predicate device."
    • Communicating the FDA's decision regarding substantial equivalence.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided text. The document does not discuss:

    1. A table of acceptance criteria and reported device performance.
    2. Sample size used for the test set or data provenance. The text only states "The components...have been tested," but gives no details.
    3. Number of experts or their qualifications for establishing ground truth.
    4. Adjudication method.
    5. Multi-reader multi-case (MRMC) comparative effectiveness study or human reader improvement with AI assistance. This is a surgical mesh, not an AI-assisted diagnostic device.
    6. Standalone (i.e., algorithm only) performance. Again, this is a surgical mesh.
    7. Type of ground truth used.
    8. Sample size for the training set.
    9. How ground truth for the training set was established.
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