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510(k) Data Aggregation

    K Number
    K183134
    Device Name
    ArcTV Transvaginal Sling System
    Manufacturer
    UroCure LLC
    Date Cleared
    2019-02-07

    (86 days)

    Product Code
    OTN
    Regulation Number
    878.3300
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K132655
    Why did this record match?
    Device Name :

    ArcTV Transvaginal Sling System

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

    The ArcTV Transvaginal Sling System is a retropubic sling indicated for a transvaginal (TV) placement of a midurethral sling for the treatment of adult female stress urinary inconting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD).

    Device Description

    The ArcTV Transvaginal Sling System is a sterile, single-use system, consisting of a Handle, two delivery Needles and a Sling assembly. The tip portion of each delivery Needle is configured to allow for passage through tissue. The opposite end of the Needle is configured to connect with the Handle. The Handle is detachable and is used to direct both delivery Needles through tissue. The Sling assembly includes one piece of loosely knitted polymeric Mesh with an integrated bioresorbable Suture, two removable plastic insertion Sheaths, and two Sling Connectors. The Suture is an integral feature of the Mesh. The Suture and Mesh allow for adjustment of the Sling after initial placement in the patient without the use of additional tools. The two plastic Sheaths facilitate the placement of the Sling. The Sling Connectors, Sheaths, Needles, and Handle are used to facilitate placement of the Sling assembly, and are not implanted. The Mesh and the bioresorbable Suture are permanently implanted.

    AI/ML Overview

    The provided document is a 510(k) summary for the ArcTV Transvaginal Sling System. This document details the device, its intended use, and its substantial equivalence to a predicate device. However, it does NOT contain detailed information about acceptance criteria for a "device" in the context of an AI/ML algorithm or a study proving that the device meets those criteria.

    Therefore, I cannot provide the requested information about acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details as this document is for a physical medical device (a surgical mesh system) and not an AI/ML powered device.

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