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510(k) Data Aggregation

    K Number
    K091094
    Device Name
    PARCUS V-LOX PEEK CF SUTURE ANCHOR, MODELS: 10253, 10254, 10263, 10264
    Manufacturer
    PARCUS MEDICAL, LLC
    Date Cleared
    2009-09-30

    (167 days)

    Product Code
    MBI,HWC
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K090075,K072785
    Why did this record match?
    Device Name :

    PARCUS V-LOX PEEK CF SUTURE ANCHOR, MODELS: 10253, 10254, 10263, 10264

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

    The Parcus V-LoX™ PEEK CF Suture Anchors are indicated for attachment of soft tissue to bone. This product is intended for the following indications: Shoulder Rotator Cuff Repair, Acromioclavicular Separation Repair, Bankart Lesion Repair, Biceps Tenodesis, Capsular Shift or Capsulolabral Reconstruction, Deltoid Repair, SLAP Lesion Repair. Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Knee Posterior Oblique Ligament Repair, Extra Capsular Reconstruction, Illiotibial Band Tenodesis, Patellar Ligament and Tendon Avulsion Repair Foot/Ankle Lateral Stabilization, Medial Stabilization, Midfoot Reconstruction, Achilles Tendon Repair, Hallux Valgus Reconstruction, Metatarsal Ligament Repair. Elbow Tennis Elbow Repair, Biceps Tendon Reattachment. Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Hand/Wrist Ligament Reconstruction, TFCC.

    Device Description

    The Parcus V-LoX™ PEEK CF Suture Anchor is a threaded, tapered fastener for use in attachment of soft tissue to bone. The device is made from Carbon Fiber Reinforced Polyetheretherketone (PEEK CF). It comes preloaded with two #2 sutures either with or without attached needles, and is available in two different diameters, 5.5mm and 6.5mm.

    AI/ML Overview

    • Device Name: Parcus V-LoX™ PEEK CF Suture Anchor

    • Acceptance Criteria and Reported Device Performance:

    Acceptance CriteriaReported Device Performance
    Pull out strengthSubstantially equivalent to Parcus V-LoX Titanium Suture Anchors
    Insertion torqueSubstantially equivalent to Parcus V-LoX Titanium Suture Anchors

    • Sample Size Used for the Test Set and Data Provenance: Not explicitly stated. The document mentions "Test results were compared to the results for the Parcus V-LoX Titanium Suture Anchors," implying a comparative test, but specific sample sizes are not provided. The data provenance (country of origin, retrospective/prospective) is not mentioned.

    • Number of Experts Used to Establish Ground Truth and Qualifications: Not applicable. The study involved mechanical testing, not a clinical assessment requiring expert ground truth for interpretation.

    • Adjudication Method: Not applicable, as no expert adjudication of clinical outcomes was performed.

    • Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No MRMC comparative effectiveness study was done. The study focused on mechanical performance.

    • Standalone Performance: Yes, a standalone performance study was done in terms of mechanical properties (pull-out strength and insertion torque) of the device itself.

    • Type of Ground Truth Used: The "ground truth" for the mechanical testing was the objective measurement of pull-out strength and insertion torque. The comparison was made against the performance of a legally marketed predicate device (Parcus V-LoX Titanium Suture Anchors).

    • Sample Size for the Training Set: Not applicable. This was a mechanical performance study, not an AI or machine learning study requiring a training set.

    • How Ground Truth for the Training Set Was Established: Not applicable, as there was no training set.

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