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510(k) Data Aggregation

    K Number
    K982662
    Device Name
    DEPUY PROFILE ROUND HEAD INTERFERENCE SCREW, DEPUY PHANTOM RESORBABLE INTERFERENCE SCREW
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Date Cleared
    1998-10-28

    (90 days)

    Product Code
    HWC,MAI,MBI
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K955733,K981670,K961234,K960652,K960940
    Why did this record match?
    Device Name :

    DEPUY PROFILE ROUND HEAD INTERFERENCE SCREW, DEPUY PHANTOM RESORBABLE INTERFERENCE SCREW

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

    The DePuy Interference Screw Systems are intended to be used to provide interference fixation of bone-patellar tendon-bone grafts in anterior cruciate ligament (ACL) and posterior cruciate ligament (PCL) reconstruction and of soft tissue grafts in ACL reconstruction.

    Device Description

    The DePuy Interference Screw Systems are cannulated fully threaded cancellous bone screws available in three diameters (7, 8, and 9mm) in three lengths (20, 25,and 30mm), and manufactured from titanium alloy (DePuy Profile Round Head Interference Screw) and from Poly-L-lactic acid (DePuy Phantom Absorbable Interference Screw).

    AI/ML Overview
    1. Acceptance Criteria and Reported Device Performance:
    Acceptance Criteria (Implicit)Reported Device Performance
    Mechanical properties (specifically pull-out loads) comparable to previously cleared predicate devices for PCL reconstruction."Mechanical testing has shown that the mean pull-out loads of the Profile Round Head Interference Screws and the Phantom Absorbable Interference Screws are comparable to those published for the previously cleared Linvatec BioScrew indicated for interference fixation in PCL reconstruction." The submission states that the DePuy devices are "identical in design and materials" to their own previously cleared devices (K955733, K981670, K961234), with the only difference being the additional indication for PCL reconstruction. This implies that the design and material properties relevant to the new indication are sufficiently similar or demonstrated to be comparable through testing.

    1. Sample Size for Test Set and Data Provenance:
      The document does not specify the exact sample size used for the mechanical testing. The data provenance is not explicitly stated in terms of country of origin, but the testing was conducted to support a submission to the FDA (United States). The testing appears to be prospective, as it was conducted to demonstrate substantial equivalence for a new indication.

    2. Number of Experts and Qualifications:
      Not applicable. This is a medical device submission based on mechanical testing and substantial equivalence, not a study requiring expert readers for image or data interpretation.

    3. Adjudication Method:
      Not applicable for this type of submission.

    4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
      No, an MRMC comparative effectiveness study was not done. This submission focuses on the mechanical equivalence of a new indication for a medical device through lab testing, not human performance with AI assistance.

    5. Standalone Performance:
      Yes, a standalone performance assessment was conducted in the form of mechanical testing of the device's pull-out loads. The performance was assessed independently of human interaction during the test.

    6. Type of Ground Truth Used:
      The "ground truth" in this context is the established mechanical performance (pull-out loads) of a legally marketed predicate device (Linvatec BioScrew) for PCL reconstruction, as presented in published literature. The DePuy devices' performance was compared against this established benchmark.

    7. Sample Size for Training Set:
      Not applicable. This is a medical device submission based on mechanical testing and substantial equivalence. There is no "training set" in the context of an algorithm or AI.

    8. How Ground Truth for Training Set Was Established:
      Not applicable, as there is no training set. The comparison was made against published data for a predicate device.

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