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510(k) Data Aggregation

    K Number
    K181182
    Device Name
    DYNACORD Suture
    Manufacturer
    Medos International SARL
    Date Cleared
    2018-08-02

    (91 days)

    Product Code
    GAT
    Regulation Number
    878.5000
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K173859,K040004,K021434,K041553
    Predicate For
    K203186
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    DYNACORD™ suture is indicated for orthopedic procedural use in soft-tissue approximation, and/or ligation, including use with allograft tissue.

    Device Description

    DYNACORD™ Suture is a sterile non-absorbable orthopedic suture. DYNACORD™ Suture has a double sheath and core design, and contains Ultra High Molecular Weight Polyethylene, Polyester and a Silicone/NaCl core.

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for the DYNACORD™ Suture, but it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a study proving those criteria were met for an AI device.

    The document is for a non-AI medical device (surgical suture) and therefore does not discuss AI-specific metrics like sample sizes for test/training sets, ground truth establishment by experts, adjudication methods, or MRMC comparative effectiveness studies (which are relevant to AI's impact on human readers).

    However, I can extract the information that is present regarding the non-clinical testing performed for this suture, which serves as its performance and safety evaluation.

    Here's the information I can provide based on the given text:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria CategoryReported Device Performance (from Non-clinical Testing)
    USP DiameterDYNACORD™ is oversized (meets USP requirements except for oversized diameter)
    USP Knot Tensile StrengthTested and results contributed to suitability for intended use
    USP Needle AttachmentTested and results contributed to suitability for intended use
    in-vitro approximation force over timePerformance evaluated (specific quantitative results not provided)
    BiocompatibilityTested and found suitable
    SterilityTested and found suitable
    Shelf-lifeTested and found suitable
    Bacterial EndotoxinMeets endotoxin limits
    in-vivo Efficacy Evaluation (GLP)Found suitable for intended use
    in-vivo Safety Evaluation (GLP)Found suitable for intended use

    Study Proving Device Meets Acceptance Criteria:

    The document states: "Performance testing included: USP Diameter (DYNACORD™ is oversized), USP Knot Tensile Strength, USP Needle Attachment, in-vitro approximation force over time, GLP in-vivo efficacy evaluation. Safety testing included: biocompatibility, sterility, shelf-life, GLP in-vivo evaluation of DYNACORD™ safety. Bacterial endotoxin testing has been completed and results have demonstrated that the proposed devices meet the endotoxin limits."

    The conclusion is: "Results of non-clinical testing have demonstrated that the proposed devices are suitable for their intended use."

    Regarding AI-specific questions:

    • 2. Sample sized used for the test set and the data provenance: Not applicable. This is not an AI device.
    • 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 an AI algorithm is not established for this device.
    • 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
    • 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 is not an AI device.
    • 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI device.
    • 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the non-clinical tests, the "ground truth" or reference standards would be established by the standardized methods for each test (e.g., USP monographs for suture properties, recognized biocompatibility standards, sterility testing protocols, in-vivo animal model observations for efficacy and safety).
    • 8. The sample size for the training set: Not applicable. This is not an AI device.
    • 9. How the ground truth for the training set was established: Not applicable. This is not an AI device.
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