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510(k) Data Aggregation

    K Number
    K192824
    Device Name
    Parcus Knotless AP Suture Anchors
    Manufacturer
    Parcus Medical, LLC
    Date Cleared
    2019-11-02

    (31 days)

    Product Code
    MAI
    Regulation Number
    888.3030
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    K183501
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Parcus Knotless AP Suture Anchors are indicated for the attachment of soft tissue to bone. This product is intended for the following indications:

    ShoulderRotator Cuff Repair, Acromioclavicular Separation Repair,Bankart Lesion Repair, Biceps Tenodesis, Capsular Shift orCapsulolabral Reconstruction, Deltoid Repair, SLAP LesionRepair.
    KneeMedial Collateral Ligament Repair, Lateral Collateral LigamentRepair, Posterior Oblique Ligament Repair, Extra CapsularReconstruction, Iliotibial Band Tenodesis, Patellar Ligament andTendon Avulsion Repair.
    Foot/AnkleLateral Stabilization, Medial Stabilization, Midfoot Reconstruction,Achilles Tendon Repair, Hallux Valgus Reconstruction, MetatarsalLigament Repair.
    ElbowTennis Elbow Repair, Biceps Tendon Reattachment.
    Hand/WristScapholunate Ligament Reconstruction, Ulnar or Radial CollateralLigament Reconstruction, TFCC.
    Device Description

    The Parcus Knotless AP Suture Anchors consist of ribbed anchor bodies in 2.8mm, 4.5mm, and 5.5mm diameters. The anchor body is comprised of Parcus Medical's Advanced Polymer (AP) which is a formulation of ß-TCP and PLGA that has a proven record as a safe and effective absorbable material that has been used in the industry for over 10 years. This material has been developed such that it will maintain the necessary strength to insert successfully and provide the necessary resistance to pull-out long enough for the body to heal and then, over time, break down, be absorbed into the body and eventually replaced by bone. The presence of the osteoconductive ß-TCP will allow for boney replacement at the insertion site as the anchor is absorbed.

    Knotless AP Suture Anchors are provided with a single use suture threader and a single use driver. These devices are individually packaged and provided sterile.

    AI/ML Overview

    The provided document is a 510(k) premarket notification for a medical device called "Parcus Knotless AP Suture Anchors." It primarily focuses on demonstrating substantial equivalence to a predicate device based on material composition, intended use, indications for use, biocompatibility, and mechanical testing.

    This document describes a physical medical device (suture anchors) and does NOT contain information about an AI/ML-driven device. Therefore, it is impossible to extract the details requested in points 1-9, which relate specifically to the acceptance criteria and study design for an AI/ML device (e.g., test set sample size, expert ground truth, MRMC studies, standalone performance, training set details).

    The "Summary Performance Data" section mentions "pull-out strength and cyclic loading studies" and comparison with "published acceptance criteria," but these are engineering performance metrics for a physical implant, not diagnostic or clinical performance metrics for an AI/ML algorithm.

    In summary, the provided text does not describe an AI/ML device or its associated acceptance criteria and validation study as typically found in submissions for such technologies.

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