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510(k) Data Aggregation

    K Number
    K230212
    Device Name
    OrthoButton AL
    Manufacturer
    Riverpoint Medical, LLC
    Date Cleared
    2023-02-23

    (28 days)

    Product Code
    MBI
    Regulation Number
    888.3040
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    K100652,K171060
    Why did this record match?
    Reference Devices :

    K100652

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

    The Riverpoint Medical OrthoButton® AL is intended for use in the fixation of bone and soft tissue in orthopedic procedures requiring ligament or tendon reconstruction.

    Device Description

    The Riverpoint Medical OrthoButton® AL is comprised of a braided ultra-high molecular weight polyethylene ("UHMWPE") adjustable loop combine with a titanium (Ti-6A1-4V ELI per ASTM F136) plate. The device is provided sterile for single use. The device is intended for use in a hospital/clinic/surgical setting.

    AI/ML Overview

    This document does not describe an AI/ML powered device, nor does it describe software that provides automated analysis or diagnosis. The device, OrthoButton® AL, is a physical medical device (Fastener, Fixation, Non-Degradable, Soft Tissue) used in orthopedic procedures. Therefore, the questions related to acceptance criteria, AI performance, ground truth, and study design for an AI/ML system are not applicable to this submission.

    The document discusses performance data related to the physical device's characteristics (sterilization, biocompatibility, stability, usability) and its substantial equivalence to a predicate device.

    To answer your request, if this were an AI/ML device, the relevant information would typically be found in a section detailing "Software Verification and Validation" or "Clinical Performance Studies" specifically for the algorithmic aspects. This document focuses on the physical properties and intended use of a mechanical medical device.

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