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510(k) Data Aggregation

    K Number
    K193479
    Device Name
    Sternal Cable System
    Manufacturer
    A&E Medical Corporation
    Date Cleared
    2020-03-23

    (98 days)

    Product Code
    JDQ
    Regulation Number
    888.3010
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K180582
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Cardiovascular surgery - closure of the sternum following sternotomy.

    Device Description

    The Sternal Cable System is an alternative over traditional monofilament sternal wire used for cardiovascular sternal closure following sternotomy. The system consists of multi-strand stainless steel and titanium cables and crimps, which are tensioned and secured around the bone using a tensioner/crimper instrument. Multiple “figure 8” constructs work as one unit to provide stabilization.

    Cables are manufactured from titanium 6Al-4V ELI alloy (ASTM F136) or 316L stainless steel (ASTM F138); CP titanium (ASTM F67) or 316L stainless steel (ASTM F138) crimps are provided to match the corresponding cable materials. However, the different metals are never to be mixed. Non-implantable leaders are manufactured from 316L stainless steel (ASTM F138) or titanium 3Al/2.5V Alloy (ASTM B863) and needles are 420 or 470 stainless steel.

    The implants are provided sterile for single-use but must never be re-sterilized; reusable instruments are supplied non-sterile and must be steam sterilized by the user prior to use in accordance with the instructions for use. Cases are supplied for sterilization and transport of the instruments.

    AI/ML Overview

    The provided document is a 510(k) Summary for the Sternal Cable System and primarily focuses on demonstrating substantial equivalence to a predicate device, particularly for the addition of Magnetic Resonance (MR) conditional safety labeling. It is not a study that evaluates the performance of an AI medical device, but rather a conventional medical device.

    Therefore, many of the requested criteria, such as "acceptance criteria for an AI medical device," "sample size for the test set," "number of experts," "adjudication method," "MRMC study," "standalone performance," and "ground truth establishment," are not applicable to this document as it does not describe an AI medical device or its performance study.

    However, I can extract information relevant to the device's MR Conditional safety labeling, which is the core of this submission's "study" aspect:

    1. A table of acceptance criteria and the reported device performance (for MR safety):

    Acceptance Criteria (from referenced ASTM standards)Reported Device Performance
    Magnetically Induced Displacement Force: Sufficiently low so as not to pose an additional hazard.The device meets the acceptance criteria (implied by "MR Safety Evaluation following standards listed below" and "Testing identified in this summary has all passed acceptance criteria established by the predicate device where applicable.").
    Magnetically Induced Torque: Sufficiently low so as not to pose an additional hazard.The device meets the acceptance criteria.
    Radio-Frequency (RF) Induced Heating: Heating within acceptable limits (e.g., < 2°C or 2.4°C for certain scenarios, commonly).The device meets the acceptance criteria.
    MR Image Artifacts: Artifacts do not obscure the region of interest or clinical information.The device meets the acceptance criteria.

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

    • Sample Size: Not explicitly stated as a number of patient cases, but rather as the number of devices or configurations tested. Given the nature of MR safety testing (physical properties of materials and device geometry), it would involve testing representative samples of each cable and crimp material/configuration.
    • Data Provenance: This is non-clinical testing performed on the devices themselves. There is no patient data involved.

    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 MR safety is established by physical measurements and adherence to engineering standards (ASTM), not by expert consensus on clinical images or outcomes.

    4. Adjudication method for the test set:

    • Not applicable. The "test set" here refers to physical devices undergoing MR safety testing, not clinical data requiring adjudication.

    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:

    • No. This is not an AI device, and therefore no MRMC study for AI assistance was performed.

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

    • Not applicable. This is not an algorithm.

    7. The type of ground truth used:

    • For MR safety, the "ground truth" is based on objective physical measurements (e.g., direct measurement of displacement force, temperature change, and visual assessment of artifact size) conducted according to the specified ASTM standards. These standards define the acceptable limits for each parameter.

    8. The sample size for the training set:

    • Not applicable. There is no training set as this is not a machine learning or AI device.

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

    • Not applicable. See point 8.
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