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510(k) Data Aggregation

    K Number
    K121235
    Device Name
    LEIBINGER ADVANCE INTERNAL MIDFACE DISTRACTION SYSTEM
    Manufacturer
    Stryker
    Date Cleared
    2014-01-09

    (625 days)

    Product Code
    JEY
    Regulation Number
    872.4760
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K972154,K022005,K003883,K092743
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Leibinger Advance Internal Midface Distraction System is intended to be used for cranial, monobloc and/or midface distraction osteogenesis of the craniofacial skeleton.

    The Leibinger Advance Internal Midface Distraction System is indicated for the treatment of syndromic and non-syndromic craniosynostosis, midface retrusion, congenital midfacial hypoplasia, and craniofacial dysostosis in patients two years of age and older.

    Device Description

    The Leibinger Advance Internal Midface Distraction System is a distraction system consisting of the following major components: a distractor frame which incorporates connection screws for the plates, a removable activation rod, plates, and an activation key. The plates and frame initially stabilize and then gradually distract the osteotomy. The removable activation rod, covered with a protective sheath, is connected to the frame and provides the point of attachment for the activation key used to initiate the distraction of the osteotomy.

    AI/ML Overview

    The Leibinger Advance Internal Midface Distraction System is a bone distraction system, not an AI-powered diagnostic device. Therefore, many of the requested categories related to AI performance, such as sample sizes for test/training sets, expert ground truth, adjudication methods, and MRMC studies, are not applicable to this submission.

    Here's an analysis based on the provided document:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria CategorySpecific Test/Evaluation PerformedReported Performance
    BiocompatibilityBiocompatibility testingSuccessfully passed all tests
    CleaningCleaning testingSuccessfully passed all tests
    SterilizationSterilization testingSuccessfully passed all tests
    Corrosion ResistanceCorrosion resistance testingSuccessfully passed all tests
    Mechanical Strength (Plates)Determination of moments of inertia of platesSuccessfully passed all tests
    Mechanical Strength (Distractor)Four-point bending of distractor with platesSuccessfully passed all tests
    Mechanical Strength (Distractor)In-plane bending testsSuccessfully passed all tests
    Mechanical Strength (Distractor)Out-of-plane bending testsSuccessfully passed all tests
    Functionality/Operational PrincipleComparison to predicate devicesOperational principle identical to predicate devices (e.g., Cohen Distractor System)
    Material InformationMaterial composition analysisDistractor made of stainless steel & titanium alloy; activation rod of stainless steel & PTFE; plates/screws of pure titanium or titanium alloy. All materials biocompatible, corrosion-resistant, non-toxic.
    DesignComparison to predicate devicesDesign principles identical to predicate Cohen Distractor System. Plates nearly identical.
    PackagingAssessment of packaging stateDelivered non-sterile, same as predicate.

    2. Sample size used for the test set and the data provenance:

    • Not Applicable. No clinical "test set" in the context of AI performance was used. The non-clinical testing involved material and mechanical property assessments of the device components. The document does not specify sample sizes (e.g., number of units tested) for these engineering tests. Data provenance is internal to Stryker Craniomaxillofacial, as these are in-house engineering and materials tests.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

    • Not Applicable. Ground truth for AI performance is not relevant here. The "ground truth" for the non-clinical tests would be established by validated engineering standards and testing protocols, performed by qualified engineers and technicians.

    4. Adjudication method for the test set:

    • Not Applicable. No adjudication method for a test set of data points is relevant. The "adjudication" for mechanical and material tests typically involves adherence to established industry standards (e.g., ASTM, ISO) and internal quality control procedures.

    5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

    • Not Applicable. This device is a surgical instrument, not an AI-assisted diagnostic tool. No MRMC study was conducted.

    6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

    • Not Applicable. This device does not involve an algorithm.

    7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

    • Engineering Standards and Material Specifications. For the non-clinical tests, the "ground truth" refers to the established specifications for biocompatibility, material properties (e.g., corrosion resistance, strength), and mechanical performance (e.g., bending strength, moments of inertia). These are validated through standardized testing methodologies and material certifications.

    8. The sample size for the training set:

    • Not Applicable. No training set in the context of AI was used.

    9. How the ground truth for the training set was established:

    • Not Applicable. No training set in the context of AI was used.
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