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510(k) Data Aggregation

    K Number
    K222161
    Device Name
    Arthrex Knotless FiberTak Biceps Suture Anchor
    Manufacturer
    Arthrex Inc.
    Date Cleared
    2022-08-11

    (22 days)

    Product Code
    MBI
    Regulation Number
    888.3040
    Type
    Special
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K193503,K203268
    Why did this record match?
    Device Name :

    Arthrex Knotless FiberTak Biceps Suture Anchor

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

    The Arthrex Knotless FiberTak Biceps Suture 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:
    • Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
    • Shoulder: Rotator Cuff Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
    •Hand Wrist: Scapholunate Ligament Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PP, DIP and MCP joints for all digits, digital tendon transfers, Carpal Ligament Reconstruction and Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty)
    •Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction
    •Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Joint Capsule Closure
    •Hip: Capsular repair, Acetabular labral repair, Gluteal Tendon Repair.

    Device Description

    The proposed Arthrex Knotless FiberTak Biceps Suture Anchor is an "all-suture" soft tissue device intended to be used for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip.

    The anchor is constructed from a hallow braid of polyester with pre-loaded suture components composed of UHWMPE or a polyblend of UHMWPE and polyester. The anchor is preloaded on a disposable inserter and is sold sterile single use.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and the study information for the Arthrex Knotless FiberTak Biceps Suture Anchor, based on the provided text:

    Device: Arthrex Knotless FiberTak Biceps Suture Anchor

    1. Table of Acceptance Criteria and Reported Device Performance

    The provided text describes a "Special 510(k)" submission for a line extension, meaning the device is being compared to a very similar predicate device. Therefore, the acceptance criteria here are primarily demonstrating equivalent performance to the predicate device in specific areas, rather than meeting absolute numerical thresholds for an entirely new device.

    Acceptance Criteria (Implied)Reported Device Performance
    Mechanical StrengthDemonstrated non-negative impact on mechanical strength compared to predicate.
    StiffnessDemonstrated non-negative impact on stiffness compared to predicate.
    BiocompatibilityBiocompatibility testing performed to support new contact materials.
    Pyrogen LimitDevice meets pyrogen limit specifications.

    2. Sample Size Used for the Test Set and Data Provenance

    • Sample Size: The document does not explicitly state the sample size for the "Cyclic Pull-out testing" or "Biocompatibility testing."
    • Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It is implied to be laboratory testing conducted by the manufacturer, Arthrex Inc.

    3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

    This type of information is generally not applicable to mechanical or biocompatibility testing for a medical device like a suture anchor. "Ground truth" in this context would be established by standardized testing protocols and measurements, not expert consensus on interpretations of data.

    4. Adjudication Method for the Test Set

    Not applicable. As noted above, this involves laboratory performance testing against engineering and biological standards, not subjective interpretations requiring adjudication.

    5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

    No. An MRMC study is not relevant for this type of device (a suture anchor). MRMC studies are typically used for diagnostic devices (e.g., imaging AI) to assess how much human performance (e.g., radiologists' diagnostic accuracy) improves with AI assistance. This device is a surgical implant.

    6. Standalone (Algorithm Only) Performance Study

    No. This is not an algorithmic or AI-based device. It is a physical medical implant.

    7. Type of Ground Truth Used

    • Mechanical Strength/Stiffness: Ground truth is based on established engineering principles and measurements from standardized pull-out and cyclic loading tests, primarily for comparison against the predicate device.
    • Biocompatibility: Ground truth is established by recognized biocompatibility standards and specific tests (e.g., cytotoxicity, sensitization, irritation) according to ISO 10993.
    • Pyrogenicity: Ground truth is established by pharmacopeial standards (EP 2.6.14/USP ) for bacterial endotoxin limits.

    8. Sample Size for the Training Set

    Not applicable. This device is a physical medical implant, not an AI/ML algorithm that requires a training set.

    9. How the Ground Truth for the Training Set Was Established

    Not applicable, as there is no training set for this device.

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