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    K Number
    K162996
    Device Name
    INVISIKNOT Ankle Syndesmosis Repair Kit
    Manufacturer
    SMITH & NEPHEW, INC.
    Date Cleared
    2017-06-08

    (224 days)

    Product Code
    HTN
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K132357,K083070
    Why did this record match?
    Device Name :

    INVISIKNOT Ankle Syndesmosis Repair Kit

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

    The Smith & Nephew INVISIKNOT Ankle Syndesmosis Repair Kit fracture device is indicated to provide fixation as an adjunct to fracture repair hardware during the healing period following an ankle syndesmotic trauma with fracture.

    Device Description

    Smith & Nephew INVISIKNOT Ankle Syndesmosis Repair Kit is a sterile, single-use, implant construct. The implants are composed of three components: a Plug type lateral button and a medial button, two stainless steel fixation devices and an ultrahigh molecular weight polyethylene (UHMWPE) suture tape. The suture tape has a one-way sliding knot to facilitate reduction. The kit also contains a polyester suture attached to one of the fixation devices to enable passing the medial button from the lateral side to the medial side and a 3.5 mm drill tip passing pin to enable preparation of the fibula and the tibula and the tibia. The eyelet in the passing pin enables delivery of the medial button from the lateral side.

    AI/ML Overview

    This document is a 510(k) premarket notification for a medical device called the "INVISIKNOT Ankle Syndesmosis Repair Kit." It describes the device, its intended use, and argues for its substantial equivalence to previously cleared devices.

    It is crucial to understand that this document describes a traditional medical device (an implantable surgical kit), not an AI/ML-driven device. Therefore, the standard elements requested in the prompt regarding AI/ML device testing (such as acceptance criteria for AI performance metrics, sample sizes for test/training sets for AI, expert adjudication of AI ground truth, MRMC studies, or standalone algorithm performance) are not applicable or detailed in this submission.

    The document focuses on the mechanical and biological performance of the physical medical device.

    However, I will extract information related to "acceptance criteria" and "proof of meeting criteria" as broadly as possible within the context of this specific, non-AI medical device.

    Acceptance Criteria and Study for the INVISIKNOT Ankle Syndesmosis Repair Kit (Non-AI Device)

    The "acceptance criteria" and "study proving the device meets criteria" in this 510(k) submission refer to the mechanical performance, material composition, and biological safety of the INVISIKNOT Ankle Syndesmosis Repair Kit, not the performance of an AI algorithm.

    1. Table of Acceptance Criteria and Reported Device Performance:

    Acceptance Criteria CategorySpecific Acceptance Criteria (Implied/Stated)Reported Device Performance and Proof
    Mechanical PerformanceAbility to withstand expected loading conditions during healing period."Mechanical testing" was conducted to evaluate if the constructs can withstand expected loading conditions.
    "Data for after-fatigue displacement and passage of the device from the medial to lateral side" demonstrate substantial equivalence to predicate devices.
    Drill Tip Passing PinAbility to withstand use without breaking.Evaluated, and the device was found to "withstand use without breaking." (Implicitly, the testing confirmed this).
    Biocompatibility/SafetyAcceptable endotoxin limit for implantable devices. (Typically
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