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510(k) Data Aggregation

    K Number
    K180101
    Device Name
    HEALIX ADVANCE KNOTLESS BR Anchor
    Manufacturer
    Medos International SARL
    Date Cleared
    2018-05-10

    (114 days)

    Product Code
    MAI
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K171114,K130917,K131974,K130539,K131683,K101679,K082810,K071177,K061863,K051219
    Predicate For
    K241010
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The HEALIX ADVANCE KNOTLESS BR Anchors are indicated for use in the following procedures for reattachment of soft tissue to bone:

    Shoulder: Rotator Cuff, Biceps Tenodesis, Deltoid Repair

    Knee: Posterior Oblique, Medial Collateral Ligament (MCL), Lateral Collateral Ligament (LCL), Iliotibial (IT) Band Tenodesis

    Foot/Ankle: Achilles Tendon Repair

    Device Description

    The HEALIX ADVANCE KNOTLESS BR Anchor is a one piece implantable cannulated, threaded anchor designed to secure soft tissue to bone. The anchor is provided loaded on a disposable inserter driver device. The proposed anchor is offered in three sizes, 4.75 mm, 5.5 mm and 6.5mm. The HEALIX ADVANCE KNOTLESS BR Anchors are molded from Biocryl Rapide® (BR) material. The HEALIX ADVANCE KNOTLESS BR Anchor is provided sterile and is for single use only.

    AI/ML Overview

    This document is a 510(k) Premarket Notification from the FDA regarding the HEALIX ADVANCE™ KNOTLESS BR Anchor. It is a clearance letter and a summary of the device, not a study report or clinical trial. Therefore, it does not contain the specific information required to answer the prompt regarding acceptance criteria and performance data for an AI/ML medical device.

    The prompt is asking for details typically found in a clinical study report for an AI/ML-driven device, such as:

    1. A table of acceptance criteria and reported device performance (e.g., sensitivity, specificity, AUC).
    2. Sample size, data provenance, and retro/prospective nature of the test set.
    3. Number and qualifications of experts for ground truth.
    4. Adjudication method for golden standard.
    5. MRMC study details and effect size.
    6. Standalone algorithm performance.
    7. Type of ground truth used (e.g., pathology, clinical outcome).
    8. Training set sample size.
    9. Method for establishing training set ground truth.

    This 510(k) summary focuses on the substantial equivalence of a physical medical device (suture anchor) to predicate devices, based on material, design, and mechanical performance (fixation strength, insertion torque). It does not involve any AI/ML components or related performance metrics that would require the establishment of ground truth by multiple experts, MRMC studies, or analysis of sensitivity/specificity for diagnostic tasks.

    Therefore, I cannot fulfill the request using the provided document. The document describes a physical medical device and its premarket clearance, not an AI/ML device with associated performance studies.

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