LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K980595
    Device Name
    DEPUY ORTHOTECH CATERA SUTURE ANCHOR
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Date Cleared
    1998-05-11

    (83 days)

    Product Code
    MBI
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K926384,K902751,K920213
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The DePuy OrthoTech Catera Suture Anchor is intended for use in the shoulder for soft tissue re-attachment and capsular repair, including rotator cuff repairs, Bankart lesion repairs and SLAP lesion repairs.

    Device Description

    The Catera Suture Anchor is a titanium 6Al-4V alloy, self-threading, cancellous screw available in diameters of 3.5mm and 4.5mm with a 0.030 inch diameter cylindrical eyelet at the end. The eyelet has two semicircular slots milled in the side of the head for suture clearance. A 34 inch U.S.P. #2 nonabsorbable polyester suture is supplied pre-threaded through the eyelet with a single loop at the end of the screw. The suture anchors that are supplied with needles attached to the suture will have a Sulzle needle #394475 swedged onto one or both ends of the suture. The suture anchor's tip threads are on an incline to the full diameter (body threads). The body threads which provide the main resistance to pullout are on a slight incline. The suture anchors are supplied either pre-loaded on a driver or separately.

    AI/ML Overview

    The DePuy OrthoTech Catera Suture Anchor is a bone fixation staple and its performance was evaluated through mechanical testing.

    1. Table of Acceptance Criteria and Reported Device Performance:

    TestAcceptance CriteriaReported Device Performance
    Pull-out loads (porcine bone)Comparable to the Zimmer Statak anchorPull-out loads for the Catera Suture Anchor were comparable to the pull-out loads for the Statak anchors. Exceeded those for the Stryker and Mitek suture anchors.
    Pull-out loads (human cadaver bone)Comparable to the Zimmer Statak anchorPull-out loads for the Catera Suture Anchor were comparable to the pull-out loads for the Statak anchors.
    Maximum torque to failureBetter than or comparable to predicate devices (specific criteria not explicitly stated, but "better than" implies it met an internal standard or exceeded the predicate)Maximum torque to failure results for the Catera Suture Anchor were better than those for the Statak anchors.

    2. Sample size used for the test set and the data provenance:

    • The document does not explicitly state the numerical sample size for each test (e.g., number of anchors tested for pull-out).
    • Data Provenance: The mechanical testing was performed using:
      • Porcine bone: This is animal tissue, typically used in lab settings.
      • Human cadaver bone: This is human tissue, likely obtained from tissue banks.
      • The origin country is not specified, but the firm is located in the US. The tests were likely conducted in a laboratory setting.
    • Retrospective/Prospective: This was a prospective mechanical study, as the tests were conducted specifically to evaluate the performance of the Catera Suture Anchor against predicate devices.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

    • The concept of "experts" and "ground truth" as typically applied to clinical or diagnostic studies is not directly relevant here. This study involved mechanical testing of a medical device.
    • The "ground truth" for mechanical testing is established by standard engineering and biomechanical testing protocols, interpreted by engineers and scientists with expertise in materials science and biomechanics. The document does not specify the number or qualifications of individuals involved in generating or interpreting these mechanical test results, which is common for this type of submission.

    4. Adjudication method for the test set:

    • Not applicable. Adjudication methods (like 2+1, 3+1 consensus) are typically used in clinical studies where expert review is needed to establish a definitive diagnosis or assessment for each case. This submission describes mechanical lab testing, where raw data is collected and analyzed according to scientific methodologies.

    5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done:

    • No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study is a mechanical comparison of a new device against predicate devices, not an evaluation of human reader performance with or without AI assistance.

    6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

    • Not applicable. This device is a physical suture anchor, not an AI algorithm. Its performance is intrinsic to the device's material properties and design, evaluated through mechanical tests.

    7. The type of ground truth used:

    • For this mechanical testing, the "ground truth" is defined by the objective, quantifiable measurements obtained during the mechanical tests (e.g., force required for pull-out, torque to failure). These measurements are direct observations of the device's physical performance under specified conditions, rather than an interpretation of an image or a clinical diagnosis.

    8. The sample size for the training set:

    • Not applicable. This is not a machine learning model, so there is no "training set." The device itself (the Catera Suture Anchor) is the product being evaluated.

    9. How the ground truth for the training set was established:

    • Not applicable, as there is no training set for this type of device submission.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1