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510(k) Data Aggregation

    K Number
    K222078

    Validate with FDA (Live)

    Device Name
    Arthrex SoftStitch
    Manufacturer
    Arthrex, Inc
    Date Cleared
    2022-09-14

    (62 days)

    Product Code
    GAT
    Regulation Number
    878.5000
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K203117,K190707
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Arthrex SoftStitch is an implantable suture retention device which facilitates percutaneous or endoscopic soft tissue repairs, including the repair of meniscal tears and fixation of prosthetic or biologic material to soft tissues in minimally invasive and open surgical procedures such as rotator cuff repairs.

    Device Description

    The Arthrex SoftStitch consists of a suture implant and an implant delivery inserter. The implant is a polyester sheath preloaded on a barbed suture manufactured from #1 USP nylon monofilament. The polyester sheath is coated with beeswax.

    AI/ML Overview

    The provided document is an FDA 510(k) clearance letter and a 510(k) summary for the Arthrex SoftStitch device. It pertains to a surgical suture and implantable retention device, not an AI-powered diagnostic tool. Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of AI performance metrics, ground truth, expert adjudication, or MRMC studies is not applicable and cannot be extracted from this document.

    The document details the substantial equivalence of the modified Arthrex SoftStitch to a previously cleared predicate device (K190707) and a reference device (K203117). The performance data cited focuses on mechanical strength (tensile testing) and biocompatibility (bacterial endotoxin testing), which are standard for medical devices like sutures, but not relevant to AI/ML device performance.

    Therefore, I cannot fulfill the request as the provided text does not contain information about the development and validation of an AI-powered medical device.

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