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510(k) Data Aggregation

    K Number
    K222091
    Device Name
    Grappler Suture Anchor System
    Manufacturer
    Paragon 28, Inc.
    Date Cleared
    2022-09-14

    (61 days)

    Product Code
    MBI
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K221465,K211770,K211002
    Why did this record match?
    Reference Devices :

    K221465, K211770

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

    The Grappler Suture Anchor System is intended for the fixation of soft tissue to bone including:

    Elbow: Biceps Tendon Reattachment, Lateral Epicondylitis Repair, Tennis Elbow Repair

    Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Repair

    Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collament Reconstruction, TFCC

    Foot/Ankle: Lateral Stabilization (Brostrom-Gould, Christman-Snook Repair), Ankle Ligament Repair, Medial Stabilization (Deltoid, Spring Ligament Repair), Achilles Tendon Repair, Metatarsal Ligament Repair, Syndesmosis Repair, Hallux Valgus Reconstruction, Digital Tendon Transfers, Mid-foot Reconstruction, LisFranc Repair

    Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Extra Capsular Reconstruction, Patellar Ligament and Tendon Avulsion Repair

    Hip: Capsular Repair, Acetabular Labral Repair

    The plate interacting anchors are only indicated for the above Hand/Wrist and Foot/Ankle indications.

    Device Description

    The Grappler Suture Anchor System consists of suture anchors, suture, and the accompanying instrumentation for the intended use of soft tissue damage repair. The anchors are provided in titanium and are accompanied by suture tape composed of UHMWPE.

    AI/ML Overview

    The provided text is a 510(k) summary for a medical device called the Grappler Suture Anchor System. It asserts substantial equivalence to a predicate device and includes information about performance testing. However, it does not describe a study involving an AI algorithm or human readers.

    Therefore, I cannot provide the requested information about acceptance criteria and a study that proves a device meets acceptance criteria in the context of AI performance or human reader interaction as it is not present in the provided text.

    Specifically, the document does not contain:

    • A table of acceptance criteria and reported device performance related to AI.
    • Details about a test set (sample size, data provenance) for an AI study.
    • Information on experts used for ground truth establishment for an AI study.
    • Adjudication methods for an AI test set.
    • Results from a multi-reader multi-case (MRMC) comparative effectiveness study.
    • Stand-alone (algorithm-only) performance data.
    • Ground truth type for an AI study (e.g., pathology, outcomes).
    • Sample size or ground truth establishment method for an AI training set.

    The performance testing mentioned in the document refers to "engineering analysis" and "bacterial endotoxin testing" to demonstrate that modifications to the device do not adversely affect its original performance and that it meets specified safety criteria. This is standard for demonstrating substantial equivalence for a physical medical device, not an AI or diagnostic tool.

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