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510(k) Data Aggregation

    K Number
    K201749

    Validate with FDA (Live)

    Device Name
    Arthrex SwiveLock Anchor
    Manufacturer
    Arthrex Inc.
    Date Cleared
    2020-08-21

    (56 days)

    Product Code
    MAI,HWC
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K191226,K190728,K192532
    Predicate For
    K203495,K221364
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Arthrex SwiveLock Anchor is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip in the following procedures:

    · Shoulder: Rotator Cuff Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction

    · Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus reconstruction, Mid-foot reconstruction, Metatarsal Ligament Repair/ Tendon Repair, Bunionectomy

    · Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis and MPFL Repair/Reconstruction

    • · Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction
      · Elbow: Biceps Tendon Reattachment, Unar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair (Tennis Elbow)

    · Hip: Capsular Repair, Acetabular labral repair

    Device Description

    The Arthrex SwiveLock Anchor is a sterile two-component suture anchor comprised of an eyelet and a hollow anchor body. The Arthrex SwiveLock Anchor is pre-mounted on a driver with the anchor body and eyelet physically separated on the driver shaft. Arthrex 510(k) cleared suture may also be provided with the device.

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for the Arthrex SwiveLock Anchor. It aims to expand the indications for use of the 3.9mm BioComposite SwiveLock suture anchor to include MPFL Repair/Reconstruction. The submission focuses on demonstrating substantial equivalence to a predicate device (K192532).

    Here's an analysis of the acceptance criteria and study information based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device Performance
    Mechanical Testing: Pull-out (tensile) strength of the proposed Arthrex SwiveLock Anchor for MPFL repair/reconstruction should meet criteria established by published literature.Met the criteria established by published literature for MPFL repair/reconstruction.
    Bacterial Endotoxin Testing: Device must meet pyrogen limit specifications as per USP <161>, USP <85>, FDA Guidance for Industry Pyrogen & Endotoxin Testing, and EP 2.6.14.Met pyrogen limit specifications.
    Substantial Equivalence: The device should have the same technological characteristics (device design, sterilization, biocompatibility) and substantially equivalent intended uses as the predicate device (K192532). Differences should be minor and not raise questions concerning safety or effectiveness. (This is a regulatory rather than a performance criterion, but it's central to the submission.)The proposed and predicate devices have the same technological characteristics. Differences are minor and do not raise questions concerning safety or effectiveness.

    No clinical studies involving human readers or AI performance are mentioned in this document. This 510(k) pertains to a physical medical device and its mechanical/biocompatibility performance, not a software device that interprets images or data. Therefore, many of the requested sections below are not applicable.

    2. Sample size used for the test set and the data provenance

    • Mechanical Testing: The document does not specify the sample size for the mechanical testing (pull-out strength).
    • Bacterial Endotoxin Testing: The document does not specify the sample size for the bacterial endotoxin testing.
    • Data Provenance: Not applicable as this is laboratory testing of a device, not clinical data from patients.

    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 mechanical and endotoxin testing is established by standard laboratory methods and specifications, not by expert consensus on clinical data.

    4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

    Not applicable. Adjudication methods are relevant for expert consensus on clinical data, not for laboratory testing.

    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

    No MRMC comparative effectiveness study was done or is referenced in this document. This filing is for a physical medical device (suture anchor), not an AI-powered diagnostic or assistive tool.

    6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

    Not applicable. This is not an algorithm or AI device.

    7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

    • Mechanical Testing: Ground truth is defined by established "published literature" regarding the required pull-out strength for MPFL repair/reconstruction.
    • Bacterial Endotoxin Testing: Ground truth is defined by established regulatory and quality standards (USP <161>, USP <85>, FDA Guidance, EP 2.6.14) for pyrogen limits.

    8. The sample size for the training set

    Not applicable. This is a physical device and does not involve a "training set" in the context of machine learning.

    9. How the ground truth for the training set was established

    Not applicable. This is a physical device and does not involve a "training set" or "ground truth" establishment in the context of machine learning.

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