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510(k) Data Aggregation

    K Number
    K242631
    Device Name
    REGENETEN™ Bioinductive Implant
    Manufacturer
    Smith & Nephew Inc., Endoscopy Div.
    Date Cleared
    2024-11-26

    (84 days)

    Product Code
    OWY,ORQ
    Regulation Number
    878.3300
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K222501
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The REGENETEN™ Bioinductive* Implant is indicated for the management and protection of tendon or extra-articular ligament injuries in which there has been no substantial loss of tendon or ligament tissue. * Bioinductivity has been demonstrated for tendon only.

    The REGENETEN Bioinductive Implant Delivery System is indicated for the arthroscopic delivery of the REGENETEN Bioinductive Implant.

    Device Description

    The REGENETEN™ Bioinductive Implant is a bioabsorbable implant device that provides a layer of collagen over injured tendons or ligaments. The implant is designed to provide a layer of collagen between a tendon or ligament and the surrounding tissue. After hydration, the implant is an easy-tohandle, pliable, nonfriable, porous collagen sheet. The REGENETEN Bioinductive Implant is provided sterile, non-pyrogenic, for single-use only, in a variety of sizes, in a dual sterile seal.

    AI/ML Overview

    The provided text is a 510(k) summary for the REGENETEN™ Bioinductive Implant, focusing on demonstrating substantial equivalence to a predicate device for an expanded indication for use (inclusion of extra-articular ligament injuries). It does not describe an AI/ML device or its performance against acceptance criteria in the manner requested (e.g., sensitivity, specificity, MRMC study, expert ground truth adjudication).

    Therefore, it is not possible to extract the requested information regarding acceptance criteria, device performance metrics (like sensitivity, specificity), sample sizes for test/training sets, expert qualifications, or details of MRMC studies and ground truth establishment, as this documentation pertains to a medical device (bioinductive implant) rather than a software-as-a-medical-device (SaMD) or AI-powered diagnostic tool. The document details the device's physical characteristics, intended use, and the rationale for expanding its indications based on an animal study, not an AI model's performance.

    To answer your request, I would need a 510(k) summary or similar regulatory document describing the validation of an AI/ML-powered medical device.

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