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510(k) Data Aggregation

    K Number
    K963618
    Manufacturer
    Date Cleared
    1996-11-12

    (63 days)

    Product Code
    Regulation Number
    888.3030
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SYNTHES SIMPLE SMALL EXTERNAL FIXATOR (SSEF)

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

    The Synthes SSEF stabilizes fractures of the distal radius. The components that make up a SSEF frame include the Schanz screws, adjustable clamps, rods, and end caps.

    Device Description

    The components that make up a SSEF frame include the Schanz screws, adjustable clamps, rods, and end caps. The adjustable clamps of the SSEF are manufactured from a titanium alloy and stainless steel. The rods of the SSEF are manufactured from carbon fiber reinforced epoxy and the end caps of the SSEF are manufactured from polyvinyl chloride.

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to answer your request. The document describes a medical device called the "Synthes SSEF" and compares it to another device, the "EBI's Orthofix Penning Dynamic Wrist Fixator," based on mechanical testing.

    However, it does not discuss:

    • Acceptance criteria or reported device performance in the context of a study involving AI or diagnostic accuracy. The "performance" mentioned refers to mechanical performance, not diagnostic.
    • Sample sizes, data provenance, ground truth establishment, expert qualifications, or adjudication methods. These are typical elements of studies evaluating AI or diagnostic tools, which is not the subject of this document.
    • MRMC comparative effectiveness studies or standalone algorithm performance.

    Therefore, I cannot populate the table or provide the detailed information requested based on this text.

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