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510(k) Data Aggregation

    K Number
    K970549
    Device Name
    TITANIUM ALLOY BONE SCREWS
    Manufacturer
    AESCULAP, INC.
    Date Cleared
    1997-04-30

    (77 days)

    Product Code
    HWC
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K930107,K912598
    Why did this record match?
    Reference Devices :

    K930107, K912598

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

    The titanium alloy cortical bone screws presented in this submission are intended for long and small bone fracture fixation.

    Device Description

    The subiect of this premarket notification are 4.0mm titanium alloy (partially threaded and fully threaded) bone screws and associated manual orthopedic instruments designed to assist screw fixation.

    AI/ML Overview

    This 510(k) summary for the Aesculap Titanium Alloy Bone Screws does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, as it pertains to AI/ML or diagnostic performance.

    The document describes a medical device, specifically bone screws, and focuses on its substantial equivalence to previously marketed devices. The "Performance Data" section explicitly states: "No applicable performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices. However, fatigue testing was performed on the titanium alloy screws; this information is detailed in the application. The Titanium Alloy Bone Screws will be manufactured in accordance with ISO and German Din Standards."

    This indicates that the performance data described here is related to mechanical testing (fatigue testing) of the physical screws, not a study evaluating diagnostic performance, AI algorithm performance, or human reader improvement with AI assistance.

    Therefore, I cannot provide the requested table and details because the provided text does not describe:

    1. Acceptance criteria related to AI/ML performance.
    2. A study proving diagnostic or AI/ML performance.
    3. Details about sample sizes for test/training sets, experts, or ground truth relevant to AI/ML or diagnostic studies.
    4. Information about MRMC studies or standalone algorithm performance.
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