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510(k) Data Aggregation

    K Number
    K230938

    Validate with FDA (Live)

    Device Name
    ARIX Humerus System
    Manufacturer
    Jeil Medical Corporation
    Date Cleared
    2023-05-03

    (30 days)

    Product Code
    HRS,HWC
    Regulation Number
    888.3030
    Type
    Special
    Panel
    Orthopedic
    Age Range
    All
    Reference & Predicate Devices
    K172008
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ARIX Humerus System is indicated for fracture dislocations, osteotomies and non-unions of the proximal humerus, particularly in osteopenic bone.

    Device Description

    The ARIX Humerus System is rigid fixation consisting of plates and screws in various configurations, shapes and sizes. The ARIX Humerus System is consists of plates and screws. The ARIX Humerus System is made of Pure Titanium and 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 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications, which h are widely used for surgical implants with well-known biocompatibility. The plates vary essentially through different lengths and number of plate holes. The screws vary essentially through different lengths and diameters. It also includes various manual surgical instruments, as drill bits, driver shafts, depth gauge. The ARIX Humerus System is not provided sterile. It is required to reach a SAL of 106 by the hospital prior to surgery.

    AI/ML Overview

    I'm sorry, but based on the provided text, there is no information about a study proving that an AI/device meets acceptance criteria, nor details about acceptance criteria for an AI/device.

    The document is a 510(k) premarket notification for a medical device called the "ARIX Humerus System," which is a metallic bone fixation appliance (plates and screws). The document focuses on demonstrating substantial equivalence to a predicate device (K172008) based on material, design, function, and mechanical performance through bench testing.

    Therefore, I cannot provide the requested information, as the input document does not contain data related to an AI/device performance study.

    The document explicitly states under "Clinical Test Summary":
    "No clinical studies were considered necessary and performed."

    This further confirms that no study of the type you're asking about (evaluating an AI's performance) was conducted or reported in this submission.

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