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510(k) Data Aggregation

    K Number
    K140259
    Device Name
    VARIAX CLAVICLE HOOK PLATE
    Manufacturer
    Stryker Trauma AG
    Date Cleared
    2014-04-01

    (57 days)

    Product Code
    HRS,HWC
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K073527,K101056,K132502,K113760,K130116,K030909,K061753
    Why did this record match?
    Device Name :

    VARIAX CLAVICLE HOOK PLATE

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

    Intended for fixation of lateral clavicle fractures, osteotomies, mal-unions, non-unions, and dislocations of the acromioclavicular joint.

    Device Description

    This Traditional 510(k) submission is being supplied to the U.S. FDA to provide authorization to market a line extension to the VariAx Clavicle System, which was previously cleared in VariAx Clavicle System (K113760 & K130116). The VariAx Clavicle System consists of anatomically contoured. Anterior and Superior Lateral Plates as well as Anterior and Superior Midshaft Plates. The subject plates are fixed to the clavicle using 3.5mm locking or non-locking screws. These screws were cleared in K073527, K101056 and K132502. This 510(k) submission is intended to introduce Hook Plates to the currently marketed VariAx Clavicle System. The plates are manufactured from Titanium Alloy per ASTM F136 (plate) and Commercially Pure Titanium per ASTM F67 (screw holes).

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and the study information based on the provided document:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria CategorySpecific Acceptance CriteriaReported Device Performance
    Mechanical PerformanceSubstantial equivalence to predicate devices (VariAx Clavicle System, AAP AcroPlate, Synthes (USA) Clavicle Hook Plates) in terms of fatigue properties.Testing demonstrated that the VariAx Clavicle Plate System is substantially equivalent to the predicate devices. Fatigue testing specifically confirmed substantial equivalence between the subject VariAx Clavicle Hook plate and the predicate AAP AcroPlate.
    BiocompatibilityMaterials consistent with established standards for medical implants (Titanium Alloy per ASTM F136, Commercially Pure Titanium per ASTM F67).Plates manufactured from Titanium Alloy per ASTM F136 (plate) and Commercially Pure Titanium per ASTM F67 (screw holes). This implicitly suggests compliance with biocompatibility standards for these materials.
    DesignSubstantial equivalence to predicate devices in design.Design is stated to be substantially equivalent to predicate devices.
    Intended UseAlignment with intended use of predicate devices for fixation of specific clavicle conditions.Intended use matches predicate devices: fixation of lateral clavicle fractures, osteotomies, mal-unions, non-unions, and dislocations of the acromioclavicular joint.

    2. Sample Size Used for the Test Set and Data Provenance

    • Sample Size for Test Set: Not explicitly stated as a numerical sample size. The document mentions "Non-clinical laboratory testing" and "fatigue testing" which would involve a certain number of test samples (e.g., plates) but the exact quantity is not specified.
    • Data Provenance: The testing was "Non-clinical laboratory testing" conducted by the sponsor (Stryker Trauma AG). This indicates it was likely conducted in a controlled lab environment. No information on country of origin of data beyond the sponsor's location (Mahwah, NJ) is provided. It is considered prospective in the sense that the tests were designed and executed to evaluate this specific device prior to its marketing.

    3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

    Not applicable. This was a non-clinical, mechanical and material testing study, not a clinical study requiring expert assessment of patient data.

    4. Adjudication Method for the Test Set

    Not applicable, as it was a non-clinical, mechanical and material testing study. The "adjudication" was based on comparing the mechanical performance data (e.g., fatigue curves, stress analysis from FEA) of the subject device against the established performance of the predicate device.

    5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

    No. This document explicitly states: "Clinical testing was not required for this submission." Therefore, no MRMC study was conducted.

    6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

    No. This is a medical device (bone fixation plate), not an AI algorithm. Therefore, a standalone algorithm performance study is not applicable.

    7. The Type of Ground Truth Used

    The "ground truth" in this context refers to the established performance characteristics (e.g., fatigue limits, material properties, structural integrity) of the predicate devices. The subject device's performance was compared against these established standards as determined through engineering and material science testing (e.g., fatigue testing, Finite Element Analysis).

    8. The Sample Size for the Training Set

    Not applicable. This is a medical device, not an AI model, so there is no concept of a "training set" in the traditional sense of machine learning.

    9. How the Ground Truth for the Training Set Was Established

    Not applicable, as there is no training set for this type of medical device.

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