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510(k) Data Aggregation

    K Number
    K031519
    Device Name
    CUFFLOK ANCHOR
    Manufacturer
    MITEK WORLDWIDE
    Date Cleared
    2003-06-06

    (22 days)

    Product Code
    MAI,GAT
    Regulation Number
    888.3030
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    K003076
    Why did this record match?
    Device Name :

    CUFFLOK ANCHOR

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

    The CUFFLOK Anchor is indicated for shoulder rotator cuff repair.

    Device Description

    The CUFFLOK Anchor is a partially bioabsorbable three-part polymer implant designed for use in shoulder rotator cuff repair and is used to secure soft tissue to bone. The three components of the implant are a tapered tip (PLA with blue dye #6), a sleeve (polypropylene blue) and an inner suture pin (PLA with blue dye #6). The anchor is also provided with ETHIBOND non-absorbable sutures and a stainless steel needle. Similar to the currently marketed CUFFTACK Anchor, the implant is mounted on a stainless steel trocar and placement of the implant is facilitated via use of a Delivery Gun.

    AI/ML Overview

    Here's an analysis of the provided text regarding the CUFFLOK Anchor's acceptance criteria and studies:

    Summary of Device and Approval:

    The CUFFLOK Anchor is a partially bioabsorbable three-part polymer implant designed for use in shoulder rotator cuff repair. It is intended to secure soft tissue to bone. The FDA granted substantial equivalence (K031519) to the CUFFTACK Anchor (K003076) based on the information provided.

    Acceptance Criteria and Study Details for CUFFLOK Anchor:

    The provided document does not contain information about specific acceptance criteria related to a performance study with defined metrics (e.g., accuracy, sensitivity, specificity, or specific mechanical strength values) and subsequent reporting of device performance against these criteria.

    Instead, the approval for the CUFFLOK Anchor appears to be based on demonstrating substantial equivalence to a predicate device (CUTTACK Anchor) and confirming biological compatibility.

    Below, I've structured the answer based on the questions, indicating where information is present or absent in the provided text.

    1. Table of Acceptance Criteria and Reported Device Performance:

      Acceptance CriteriaReported Device Performance
      Biocompatibility: Non-toxicDemonstrated to be non-toxic (as stated in the "Safety" section).
      Biocompatibility: Non-irritatingDemonstrated to be non-irritating (as stated in the "Safety" section).
      Biocompatibility: Non-sensitizingDemonstrated to be non-sensitizing (as stated in the "Safety" section).
      Biocompatibility: Non-cytotoxicDemonstrated to be non-cytotoxic (as stated in the "Safety" section).
      Substantial Equivalence: Similar indications for use (shoulder rotator cuff repair)Met: Indicated for shoulder rotator cuff repair, same as predicate (implied by FDA's substantial equivalence determination).
      Substantial Equivalence: Similar technology/design (three-part polymer implant, delivery method via trocar/Delivery Gun)Met: "Similar to the currently marketed CUFFTACK Anchor, the implant is mounted on a stainless steel trocar and placement of the implant is facilitated via use of a Delivery Gun."
      Performance (e.g., mechanical strength, pull-out force, tissue integration, etc.)Not specified/Explicitly reported in the provided text. The document relies on substantial equivalence to the predicate for assumed performance.

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

      • Sample Size: Not specified. The document refers to "biocompatibility studies" but does not detail the sample size or design of these studies. No performance "test set" in the context of an AI/software device is mentioned.
      • Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).

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

      • Not applicable. The document does not describe a process involving human experts to establish ground truth for a test set, as this is a physical medical device, not an AI/software product requiring image interpretation or similar.

    4. Adjudication Method for the Test Set:

      • Not applicable. No test set requiring expert adjudication is described.

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

      • No. The document makes no mention of an MRMC study. This type of study is typically relevant for interpretative AI devices where human performance with and without AI assistance is evaluated.

    6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

      • No. This is a physical medical device, not an algorithm.

    7. Type of Ground Truth Used:

      • The "ground truth" for the CUFFLOK Anchor in the context of this submission appears to be:
        • Biocompatibility test results: Demonstrating non-toxicity, non-irritation, non-sensitization, and non-cytotoxicity.
        • Design and Material Equivalence: Comparison to the predicate device (CUTTACK Anchor) for design, materials (PLA, polypropylene), and intended use. The FDA's substantial equivalence finding validates this comparison.
      • No pathology, imaging, or outcomes data used as "ground truth" for performance comparison is described in this document.

    8. Sample Size for the Training Set:

      • Not applicable. This is not an AI/ML device that requires a training set.

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

      • Not applicable. No training set is involved.
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