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    K Number
    K113251
    Device Name
    SYNTHES MATRIXMANDIBLE PERFORMED RECONSTRUCTION PLATES
    Manufacturer
    SYNTHES INC
    Date Cleared
    2011-12-21

    (48 days)

    Product Code
    JEY
    Regulation Number
    872.4760
    Type
    Special
    Panel
    Dental
    Reference & Predicate Devices
    K091144
    Why did this record match?
    Device Name :

    SYNTHES MATRIXMANDIBLE PERFORMED RECONSTRUCTION PLATES

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

    The Synthes MatrixMANDIBLE Preformed Reconstruction Plates are intended for use in oral and maxillofacial surgery, trauma and reconstructive surgery. This includes primary mandibular reconstruction, comminuted fractures and temporary bridging pending delayed secondary reconstruction, including fractures of edentulous and/or atrophic mandibles, as well as unstable fractures.

    Device Description

    The Synthes MatrixMANDIBLE Preformed Reconstruction Plates are anatomically contoured to match the body and angle regions of the mandible in most patients. These plates are designed for use with Synthes MatrixMANDIBLE screws that come in multiple diameters and lengths to meet the anatomical needs of the patient. System components are manufactured in either titanium or titanium alloy and are intended for single use only.

    AI/ML Overview

    The acceptance criteria and study proving device performance are described below based on the provided text.

    Acceptance Criteria and Device Performance

    Acceptance CriteriaReported Device Performance
    Dynamic and Static Fatigue Life: The MatrixMANDIBLE Preformed Reconstruction Plates must demonstrate a significantly longer fatigue life compared to the 2.5mm thick MatrixMANDIBLE plates under similar loading conditions.The study concluded that the MatrixMANDIBLE Preformed Reconstruction Plates maintain a significantly longer fatigue life compared to the 2.5mm thick MatrixMANDIBLE plates when tested under similar loading conditions.

    Study Details

    1. Sample Size and Data Provenance:

      • Test Set Sample Size: Not specified. The abstract mentions "dynamic and static testing" but does not give specific sample numbers for these tests.
      • Data Provenance: The testing was "non-clinical testing" conducted by Synthes. The country of origin for the data is not explicitly stated, but Synthes is based in West Chester, PA, USA, implying the testing likely occurred there. The data is retrospective in the sense that it's reported after the tests were conducted, but it's new data generated for this specific submission, not historical patient data.

    2. Number of Experts and Qualifications for Ground Truth (Test Set): Not applicable. This was non-clinical mechanical testing, not a study requiring expert interpretation of medical images or conditions.

    3. Adjudication Method (Test Set): Not applicable due to the nature of the non-clinical mechanical testing.

    4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No. This was a non-clinical study assessing mechanical properties, not a reader study.

    5. Standalone (Algorithm Only) Performance Study: Not applicable. This device is a bone plate, so there is no algorithm or AI component. The performance was assessed through physical mechanical testing.

    6. Type of Ground Truth Used: The ground truth was established by the physical measurements and results obtained from the dynamic and static mechanical testing under controlled laboratory conditions, comparing the new plates to a predicate device's performance.

    7. Training Set Sample Size: Not applicable. This was non-clinical mechanical testing; there was no training set in the context of machine learning or AI.

    8. How Ground Truth for Training Set was Established: Not applicable.

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