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    K Number
    K242995
    Device Name
    OIC Small / Mini Fragment Plate System
    Manufacturer
    The Orthopaedic Implant Company
    Date Cleared
    2024-10-23

    (27 days)

    Product Code
    HRS
    Regulation Number
    888.3030
    Type
    Special
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K223118,K171904,K090047,K113760,K140814
    Why did this record match?
    Device Name :

    OIC Small / Mini Fragment Plate System

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

    The OIC Small / Mini Fragment Plate System is indicated for the fixation of fractures, mal-unions, non-unions or osteotomies for the clavicle, humerus, radius, ulna, metacarpal, tibia, fibula, malleolus and metatarsal.

    Device Description

    The OIC Small / Mini Fragment Plate System consists of titanium plates including the Distal Radius, Clavicle, Proximal Humerus, Tibia and Distal Fibula, 1/3 tubular, Hook, Olecranon and Mini Fragment, bone screws and instruments for implantation. The plates come in a variety of sizes and are pre-contoured to match the anatomy of the patient and accept 2.5mm and 3.5mm bone screws are available in three diameters (2.0mm, 2.5mm and 3.5mm) and range in length from 6mm to 130mm. The bone screws are available with both threaded (locking) and non-threaded (non-locking) heads. The OIC Small / Mini Fragment Plate System is made of titanium alloy in compliance with ASTM F1472 or ASTM F67. The OIC Small / Mini Fragment Plate System is provided non-sterilized by the medical facility prior to implantation.

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter and summary for the "OIC Small / Mini Fragment Plate System," which is a metallic bone fixation appliance. This document is a regulatory submission for a physical medical device, not a software-based AI/ML device.

    Therefore, the requested information regarding acceptance criteria and studies proving the device meets those criteria for an AI/ML device (e.g., acceptance criteria for AI performance metrics like diagnostic accuracy, sensitivity, specificity, AUC; sample sizes for test sets in AI studies; number of experts for ground truth establishment; MRMC studies; standalone algorithm performance; training set details) is not applicable to this submission.

    The "Performance Testing" section in the document describes mechanical testing of the plates and screws (bend testing, torsional strength, driver torque, axial pullout strength) according to ASTM standards (F382 and F543). These tests are designed to demonstrate the physical and mechanical integrity and equivalence of the device to predicate devices, which is standard for orthopedic implants.

    In summary, this document does not contain the type of information requested for a study proving an AI/ML device meets acceptance criteria.

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