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510(k) Data Aggregation

    K Number
    K073281
    Device Name
    CAIS STAPLE
    Manufacturer
    DEPUY MITEK, A JOHNSON & JOHNSON COMPANY
    Date Cleared
    2008-05-02

    (163 days)

    Product Code
    JDR
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K021953
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The CAIS Staple is an absorbable implant used in the fixation of periosteal autograft to articular cartilage lesions of the knee.

    Device Description

    The CAIS Staple is a PDS implant that attaches a scaffold to articular cartilage lesions in the knee.

    AI/ML Overview

    The provided text describes a 510(k) summary for the CAIS Staple, a medical device. However, it does not contain any information regarding specific acceptance criteria, performance metrics, or details of a study that proves the device meets such criteria.

    The document establishes substantial equivalence to a predicate device (PDS/PGA Staple, K021953) based on indications for use, technological characteristics, and comparison. It states "Results of performance and safety testing have demonstrated that the modified device is substantially equivalent to the predicate devices," but does not provide any specific data, test results, or study methodologies.

    Therefore, I cannot fulfill your request for:

    • A table of acceptance criteria and the reported device performance: This information is not present.
    • Sample size used for the test set and the data provenance: Not mentioned.
    • Number of experts used to establish the ground truth and their qualifications: Not mentioned.
    • Adjudication method: Not mentioned.
    • MRMC comparative effectiveness study: Not mentioned.
    • Standalone performance study: Not mentioned.
    • Type of ground truth used: Not mentioned.
    • Sample size for the training set: Not mentioned.
    • How the ground truth for the training set was established: Not mentioned.

    This 510(k) summary is a regulatory document focused on demonstrating substantial equivalence rather than detailing scientific studies with specific performance metrics against pre-defined acceptance criteria.

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