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510(k) Data Aggregation

    K Number
    K024060
    Device Name
    MODIFICATION TO ASNIS III CANNULATED SCREW SYSTEM
    Manufacturer
    HOWMEDICA OSTEONICS CORP.
    Date Cleared
    2002-12-20

    (11 days)

    Product Code
    HWC
    Regulation Number
    888.3040
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MODIFICATION TO ASNIS III CANNULATED SCREW SYSTEM

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

    The Asnis III Cannulated Screw System intended for fracture fixation of small and long bones and of the pelvis. The system is not intended for spinal use.

    Device Description

    This Special 510(k) submission is intended to address design modifications to the Asnis III Cannulated Screw System. Additional lengths have been added to the 8.0 mm diameter screws. The core thread diameter of the 6.5 mm diameter screws has been modified. The material, intended use, packaging and sterilization of the subject devices are identical to those of predicate devices.

    AI/ML Overview

    The provided text describes a Special 510(k) submission for modifications to the Asnis III Cannulated Screw System. This type of submission is for device modifications where "Mechanical testing and analysis demonstrates comparable properties of the subject to the predicate device." It does not contain information about an AI-powered medical device or studies related to AI performance.

    Therefore, I cannot provide details on the specific points requested (acceptance criteria, device performance, sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth types, training set sizes, or ground truth establishment for a training set) because the provided document is about a mechanical screw system modification, not an AI/software device that would typically involve such studies.

    The document explicitly states:

    • "This Special 510(k) submission is intended to address design modifications to the Asnis III Cannulated Screw System."
    • "Additional lengths have been added to the 8.0 mm diameter screws. The core thread diameter of the 6.5 mm diameter screws has been modified."
    • "Mechanical testing and analysis demonstrates comparable properties of the subject to the predicate device."

    This indicates that the modifications are purely mechanical, and the "study" demonstrating performance is mechanical testing and analysis, which confirms comparability to the predicate device, rather than clinical trials or AI performance evaluations.

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