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510(k) Data Aggregation

    K Number
    K183232
    Device Name
    Double ENDOBUTTON Fixation Device
    Manufacturer
    Smith and Nephew, Inc.
    Date Cleared
    2019-03-12

    (112 days)

    Product Code
    HTN,HWC
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K103705,K082095
    Why did this record match?
    Reference Devices :

    K103705, K082095

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

    The Double ENDOBUTTON Fixation Device is intended for the treatment of anterior glenoid bone loss using the Latarjet or bone block procedure (allograft or autograft).

    Device Description

    The subject of this Traditional 510(k) is the Double ENDOBUTTON Fixation Device. The Smith & Nephew Double ENDOBUTTON Fixation Device is used during the healing period of osteotomies for orthopedic reconstruction and to assist in the management of fracture fixation. The device consists of three components: two stainless steel fixation devices and a UHMW polyethylene suture. This device is provided sterile, for single use only.

    AI/ML Overview

    The provided document is an FDA 510(k) clearance letter and associated summary for a medical device (Double ENDOBUTTON Fixation Device). It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain the information requested in points 1-9 regarding acceptance criteria and a study proving a digital health device or AI/ML device meets those criteria.

    Specifically, the document discusses a mechanical fixation device used in orthopedic surgery, not a software device or an AI/ML algorithm. Therefore, the concepts of "acceptance criteria" for an AI/ML model, "sample size for test set," "ground truth establishment," "MRMC study," or "standalone performance" are not applicable to the content of this document.

    The performance data mentioned in the document refers to:

    • Mechanical testing: Interface pressure, suture construct tests.
    • Bacterial endotoxin testing.
    • Clinical literature review: Comparing complication rates and clinical outcome scores (ROWE, Walch-Duplay, ASES) between the device's usage and predicate screws.

    Since the document provided does not describe an AI/ML device or its validation, I cannot fill in the requested table and information.

    To answer your request, I would need a document describing the validation of an AI/ML or digital health device.

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