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510(k) Data Aggregation

    K Number
    K221731
    Device Name
    FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire
    Manufacturer
    T.A.G. Medical Products Corporation, Ltd
    Date Cleared
    2022-09-07

    (84 days)

    Product Code
    MBI
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K203117,K190125
    Predicate For
    K244015
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The FiberStitch™ Implant is intended for use as a suture retention device to facilitate endoscopic soft tissue procedures. The FiberStitch™ Implant Device is indicated for use in rotator cuff and meniscal repair procedures.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) Summary for a medical device called "FiberStitch™ Implant". This document details the device's classification, indications for use, and a comparison to predicate devices, including nonclinical testing performed to support its safety and effectiveness.

    However, the 510(k) Summary does not contain information about a study proving the device meets specific acceptance criteria based on AI performance, human reader improvement with AI assistance, or standalone algorithm performance. The testing discussed is biomechanical tensile strength testing and cadaveric evaluation to assess the device's usability and functionality for its intended surgical uses.

    Therefore, I cannot provide a response filling in the requested table and study details as they pertain to AI/algorithm performance. The document focuses on the physical and functional characteristics of a surgical implant, not a diagnostic or AI-driven medical device.

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