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510(k) Data Aggregation

    K Number
    K231441

    Validate with FDA (Live)

    Device Name
    ARIX Ankle System
    Manufacturer
    Jeil Medical Corporation
    Date Cleared
    2023-07-17

    (60 days)

    Product Code
    HRS,HWC
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Age Range
    All
    Reference & Predicate Devices
    K201656,K081284
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ARIX Ankle System is intended for use in internal fixation of the distal fibula.

    Device Description

    The ARIX Ankle System is rigid fixation consisting of plates and screws in various configurations, shapes, and sizes. The ARIX Ankle System is made of Unalloyed Titanium Alloy (Ti-6Al-4V), which meet ASTM F67, Standard Specification for Unalloyed Titanium for Surgical Implant Applications, and ASTM F136, Standard Specification for Wrought Titanium-6 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications, which are widely used for surgical implants with well-known biocompatibility.

    AI/ML Overview

    This document describes a 510(k) premarket notification for the "ARIX Ankle System," which is a device for internal fixation of the distal fibula. The submission claims substantial equivalence to existing predicate devices.

    Crucially, the provided text explicitly states there was no clinical study performed for this device, and therefore no data regarding AI performance, acceptance criteria for AI, or human reader studies.

    Therefore, I cannot provide the requested information about acceptance criteria for AI, study details (sample size, ground truth, experts, adjudication, MRMC, standalone performance), or training set information.

    The relevant section from the document states:

    "Clinical Test Summary
    No clinical studies were considered necessary and performed."

    This indicates that the FDA clearance for the ARIX Ankle System was based on non-clinical bench testing and a comparison of its technological characteristics and intended use to predicate devices, not on a study involving AI performance or human reader analysis.

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