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510(k) Data Aggregation

    K Number
    K180972
    Device Name
    ARIX Clavicle System
    Manufacturer
    Jeil Medical Corporation
    Date Cleared
    2018-10-03

    (173 days)

    Product Code
    HRS,HWC
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K130116,K112111,K170705,K171285
    Why did this record match?
    Device Name :

    ARIX Clavicle System

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

    The ARIX Clavicle System is indicated for the fixation of single, segmental and comminuted fractures, malunions, and non-unions of the clavicle.

    Device Description

    The ARIX Clavicle System is rigid fixation consisting of plates and screws in various configurations, shapes and sizes. The ARIX Clavicle System is made of Titanium Alloy (Ti-6AL-4V), which meet ASTM F136, Standard Specification for Wrought Titanium-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications, which are widely used for surgical implants with well-known biocompatibility. The plates vary essentially through different lengths and number of plate holes. The screws are selftapping, which are applied with the reconstruction locking screws together. The Locking Screws are provided with diameter 2.5, 3.5mm and Cortical Screws are provided with diameter 3.5mm. And both are provided with lengths from 6 mm to 110 mm.

    AI/ML Overview

    This document describes the regulatory approval for the ARIX Clavicle System, a medical device used for bone fixation. However, it does not contain information related to an AI/ML powered medical device. Therefore, I cannot extract the requested information regarding acceptance criteria, study details, human reader performance, or ground truth establishment for such a device.

    The provided text pertains to a traditional medical device (metallic bone fixation appliances) and details its substantial equivalence to predicate devices based on design, materials, and mechanical testing, rather than AI performance metrics.

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