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510(k) Data Aggregation

    K Number
    K083432
    Device Name
    DRILL FREE MMF SCREW
    Manufacturer
    KLS MARTIN L.P.
    Date Cleared
    2009-03-31

    (131 days)

    Product Code
    DZL
    Regulation Number
    872.4880
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    K233721,K241314
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Drill Free MMF Screw is intended for use in maxillomandibular fixation to provide stabilization of fractures of the maxilla, mandible, or both.

    Device Description

    The Drill Free MMF Screw provides temporary occlusal and fracture stabilization. These screws may be applied prior to or after exposure of the fracture.

    AI/ML Overview

    I am sorry but this document does not contain the information you are requesting. This document is a 510(k) summary for a medical device called "Drill Free MMF Screw". It focuses on establishing substantial equivalence to previously marketed predicate devices, rather than detailing a specific study with acceptance criteria and performance metrics in the way you described.

    Specifically, the document primarily discusses:

    • Intended Use: Maxillomandibular fixation for stabilization of fractures.
    • Technological Characteristics: Similarities and differences to predicate devices (mainly material composition).
    • Substantial Equivalence: Arguing that the new device is equivalent to existing ones based on intended use, manufacturing, quality systems, and material.

    It does not include information about:

    • A table of acceptance criteria and reported device performance.
    • Sample sizes, data provenance, ground truth establishment, or expert involvement for a study proving device performance against acceptance criteria.
    • Multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.

    Therefore, I cannot extract the information requested from the provided text.

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