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    K Number
    K163303
    Device Name
    OsteoMed ExtremiFix Mid and Large Screw System
    Manufacturer
    OsteoMed LLC
    Date Cleared
    2017-04-04

    (133 days)

    Product Code
    HWC,HTN
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K963172,K063298,K151021,K951389,K954330
    Why did this record match?
    Device Name :

    OsteoMed ExtremiFix Mid and Large Screw System

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

    The OsteoMed ExtremiFix Mid & Large Screw System is indicated for use in bone reconstruction, osteotomy, arthrodesis, and fracture fixation of foot, ankle, and long bones (upper and lower extremity). The screws are intended for single use only. The system drills and guide wires are single use instruments.

    Device Description

    The OsteoMed ExtremiFix Mid & Large Screw System is a rigid fixation system consisting of screws in both cannulated and solid versions, all of which are available in various overall and distal thread lengths to accommodate specific patient anatomies. The headed and headless compression screws are made of biocompatible Ti 6-Al 4-V Titanium Alloy. Longer sizes of the single-use only implants are provided individually sterile packed, while the majority of screws and all instruments are provided in modules to allow for customization specific to the surgical indication. The system includes washers for use with 4.5mm, 5.5mm, 6.5mm and 7.0mm headed screws. The washers are made of biocompatible Titanium Alloy. The OsteoMed ExtremiFix Mid & Large Screw System is sterilized in a sterilization tray which is available from OsteoMed.

    AI/ML Overview

    The provided text describes the OsteoMed ExtremiFix Mid & Large Screw System, a bone fixation device. It details the performance data presented to the FDA for substantial equivalence, which primarily relies on bench testing and biocompatibility evaluation. It explicitly states that no clinical studies or animal studies were performed to demonstrate safety and efficacy. Therefore, the concept of "acceptance criteria" and "device performance" in the context of clinical outcomes, expert adjudication, or human reader improvement with AI assistance, as outlined in the request, is not applicable to this submission.

    The acceptance criteria and performance are related to the mechanical properties and biocompatibility of the screws, compared to predicate devices.

    Here's the information parsed from the document, tailored to the available data:

    1. Table of Acceptance Criteria and the Reported Device Performance

    Acceptance Criteria (based on comparison to predicate)Reported Device PerformanceComments
    Required mechanical strength criteria for intended useMet required mechanical strength criteriaDemonstrated through verification testing against predicate devices.
    Performed equal or better than predicate devicesPerformed equal or better than predicate devicesDemonstrated through verification testing.
    Biocompatibility standards (ISO 10993-1)Conforms to ISO 10993-1 requirementsEvaluated for cytotoxicity, sensitization, irritation, systemic toxicity, sub-chronic toxicity, genotoxicity, implantation, and pyrogen testing.
    ASTM F-136 for chemical compositionConforms to ASTM F-136Applies to the Titanium alloy implant material.

    2. Sample size used for the test set and the data provenance

    • Test Set Sample Size: Not explicitly stated for each bench test. However, the testing was conducted on samples of the OsteoMed ExtremiFix Mid & Large Screw System.
    • Data Provenance: The document implies in-house laboratory testing ("Verification testing was conducted") as part of the submission to the FDA. No geographical origin or retrospective/prospective nature of the performance testing is specified beyond it being non-clinical bench testing.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

    • Not Applicable. The ground truth for this device's performance was established through standardized engineering bench tests and material characterization, not human expert interpretation or adjudication.

    4. Adjudication method for the test set

    • Not Applicable. As the performance evaluation was based on objective physical and material tests, there was no adjudication method involving human experts.

    5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

    • No. This is a medical implant (bone fixation screw system), not an AI-powered diagnostic device. Therefore, MRMC studies and AI assistance are not relevant.

    6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

    • Not Applicable. This is a medical implant, not an algorithm or software. The device itself (the screws) is the "standalone" component in the context of its physical function.

    7. The type of ground truth used

    • Bench Test Results and Material Standards: The ground truth was based on the objective measurements from bench testing (e.g., force, strength, torque, pullout) and compliance with established material standards (e.g., ASTM F-136 for Titanium alloy) and biocompatibility guidance (ISO 10993-1).

    8. The sample size for the training set

    • Not Applicable. This device does not involve a training set as it is not an AI/machine learning product. Performance was assessed through direct testing and comparison to predicate devices, not through a learning algorithm.

    9. How the ground truth for the training set was established

    • Not Applicable. (See #8).
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