LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K113004
    Device Name
    PDS(TM) BARBED SUTURES
    Manufacturer
    ETHICON, INC.
    Date Cleared
    2011-12-20

    (74 days)

    Product Code
    NEW
    Regulation Number
    878.4840
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K091087,K061037,K080985
    Why did this record match?
    Reference Devices :

    K091087

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

    PDS Barbed Sutures are indicated for general soft tissue approximation where use of an absorbable suture is appropriate.

    Device Description

    PDS Barbed Sutures (polydioxanone) monofilament synthetic absorbable sutures are prepared from the polyester, poly (p-dioxanone). The empirical molecular formula of the polymer is (C4HgO3)x . PDS Barbed Sutures will be available marketed with and without IRGACARE®+ MP (triclosan), a broad spectrum antibacterial agent, at no more than 2360 ug /m. PDS Barbed Sutures are dved with D&C Violet No. 2 (21CFR& 74.3602). PDS Barbed Sutures consists of an absorbable monofilament strand thread with unidirectional barbs, with a surgical needle attached at one end and a fixation tab at the other. The barbs and fixation tab design allow for tissue approximation without the need to tie surgical knots.

    AI/ML Overview

    The provided text does not contain information about an AI-powered device. Instead, it describes a PDS™ Barbed Suture, which is a physical surgical device.

    Therefore, I cannot provide the requested information about acceptance criteria and a study proving an AI device meets those criteria. The questions you've asked are specifically tailored to the evaluation of AI/ML-based medical devices, and this document pertains to a traditional medical device (a surgical suture).

    Here's why each of your requested points cannot be addressed with the provided text:

    1. Table of acceptance criteria and reported device performance: The document states "non-clinical laboratory testing was performed demonstrating that the device conforms to the current USP Monograph for absorbable surgical sutures, except for diameter." It also mentions "bench, human cadaver and animal testing was provided showing that the device performed as intended and as claimed." However, it does not provide specific acceptance criteria values (e.g., minimum tensile strength, degradation rates) nor detailed performance data.
    2. Sample size for the test set and data provenance: Not applicable. This refers to AI model testing.
    3. Number of experts used to establish ground truth and qualifications: Not applicable. This refers to AI model testing.
    4. Adjudication method for the test set: Not applicable. This refers to AI model testing.
    5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This refers to AI model testing.
    6. Standalone (algorithm only) performance: Not applicable. This refers to AI model testing.
    7. Type of ground truth used: Not applicable. This refers to AI model testing.
    8. Sample size for the training set: Not applicable. This refers to AI model training.
    9. How ground truth for the training set was established: Not applicable. This refers to AI model training.

    In summary, the provided document is a 510(k) summary for a surgical suture, not an AI device. Therefore, the requested information cannot be extracted.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1