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510(k) Data Aggregation

    K Number
    K142484
    Device Name
    Sternal Closure System
    Manufacturer
    JACE Medical LLC
    Date Cleared
    2014-10-31

    (57 days)

    Product Code
    HRS,HWC,JDQ
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K110574,K111908,K121302,K931271,K946173,K051165,K070169
    Predicate For
    K210290
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Sternal Closure System is intended for use in the stabilization of fractures of the sternum, including sternal fixation following sternotomy and sternal reconstructive surgical procedures.

    Device Description

    The Sternal Closure System is comprised of bone screw, bone plate and fastener components and instruments for implantation. The plates are offered in a fixed one-piece and a fastenable two-piece style. Bone screws are available in a single diameter having a range of lengths. The interconnecting components come in solid and cable versions and fasten the halves of the two-piece plate.

    AI/ML Overview

    Here's the information regarding the acceptance criteria and study for the Sternal Closure System, based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance CriterionReported Device Performance
    Mechanical Performance (Static and Dynamic Lateral Distraction)The Sternal Closure System construct performance is substantially equivalent to the Ethicon Stainless Steel Suture Wire.
    Mechanical Performance (Static Longitudinal Shear)The Sternal Closure System construct performance is substantially equivalent to the Ethicon Stainless Steel Suture Wire.
    Bone Screw Performance (ASTM F543)The Sternal Closure System screw performance is substantially equivalent to the Biomet Microfixation Sternal Closure System screws.
    General Technological CharacteristicsThe Sternal Closure System possesses the same technological characteristics as the predicate devices, including performance, implant grade materials, and basic design. Differences are supported with descriptive information and/or performance data.

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

    • Sample Size: The document does not explicitly state a numerical sample size for the "test set" in terms of number of devices tested. It refers to "worst case Sternal Closure System constructs" tested.
    • Data Provenance: Not specified in the provided text. The testing was conducted as part of the 510(k) submission, implying a laboratory setting rather than patient data.

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

    • This information is not applicable to this type of device (mechanical fixation system). The "ground truth" here is the physical performance of the device against established engineering standards and predicate device performance, not clinical interpretation by experts.

    4. Adjudication Method for the Test Set

    • Not applicable. The "adjudication method" concept is typically for clinical data or expert interpretation, not mechanical testing. The results of mechanical tests are objective measurements.

    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 mechanical surgical implant, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies are irrelevant.

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

    • Not applicable. This device is a mechanical surgical implant, not an algorithm.

    7. The Type of Ground Truth Used

    • The "ground truth" for this device's performance is based on:
      • Mechanical Test Standards: Specifically, ASTM F543 for bone screws.
      • Predicate Device Performance: Comparison to the performance of legally marketed predicate devices (Ethicon Stainless Steel Suture Wire and Biomet Microfixation Sternal Closure System screws). The implicit "ground truth" is that the new device should perform at least as well as these established devices.

    8. The Sample Size for the Training Set

    • Not applicable. This is a mechanical device, not an AI algorithm that requires a "training set" of data.

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

    • Not applicable. As above, there is no "training set" for this type of device.
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