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510(k) Data Aggregation

    K Number
    K133770
    Device Name
    A.I.M. KNOTLESS MENISCAL REPAIR DEVICE
    Manufacturer
    ANCHOR INNOVATION MEDICAL (A.I.M.)
    Date Cleared
    2014-06-10

    (181 days)

    Product Code
    GAT
    Regulation Number
    878.5000
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K072322
    Why did this record match?
    Device Name :

    A.I.M. KNOTLESS MENISCAL REPAIR DEVICE

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

    The A.I.M. Knotless Meniscal Repair Device is an implantable suture retention device which facilitates percutaneous or endoscopic soft tissue repair, including the repair of meniscal tears.

    Device Description

    The A.I.M. Knotless Meniscal Repair Device is comprised of two implants pre-threaded with commercially available Ultra High Molecular Weight Polyethylene, USP Size 0 suture pre-loaded into a needle delivery device that will allow the surgeon to repair soft tissue, including a meniscal repair. The needle tip may be available straight, curved, and/or reverse-curved.

    AI/ML Overview

    The provided text describes a medical device, the A.I.M. Knotless Meniscal Repair Device, and its 510(k) summary, but it does not contain information about acceptance criteria or a study proving the device meets specific performance metrics in the way typically associated with diagnostic AI/imaging devices.

    The document states: "Bench testing was conducted to confirm that the A.I.M. Knotless Meniscal Repair Device performs as well or better than the predicate on pull-out performance and cyclic loading." This indicates performance testing was done, but the specific acceptance criteria (e.g., minimum pull-out strength in Newtons, number of cycles survived at a certain load) and the detailed results are not provided in the given text.

    Therefore, I cannot fill out the requested table or answer most of the questions as the necessary data is absent from the provided text.

    Here's what I can infer from the text, acknowledging the limitations:

    1. Table of Acceptance Criteria and Reported Device Performance:

    Performance MetricAcceptance Criteria (Not Given)Reported Device Performance (General Statement)
    Pull-out performanceNot Specified in documentPerforms as well or better than the predicate device.
    Cyclic loadingNot Specified in documentPerforms as well or better than the predicate device.

    All other requested information regarding sample size, data provenance, experts, adjudication, MRMC studies, standalone performance, ground truth types, training set details, and ground truth establishment methods is not available in the provided document, as it focuses on a a physical medical device (suture retention device) and its substantial equivalence and not an AI or imaging diagnostic device. The 'study' mentioned is a bench test to compare mechanical properties with a predicate, not a clinical or AI performance study.

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