LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K120531
    Device Name
    VERSAFITCUP CC TRIO-ADDITIONAL LINERS
    Manufacturer
    MEDACTA INTERNATIONAL
    Date Cleared
    2012-04-18

    (56 days)

    Product Code
    LZO,MEH
    Regulation Number
    888.3353
    Type
    Special
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K072857,K073337,K080885,K082792,K083558,K112115,K093944,K103189,K103352,K103721,K092265
    Why did this record match?
    Device Name :

    VERSAFITCUP CC TRIO-ADDITIONAL LINERS

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

    The hip prosthesis is designed for cementless use in total hip arthroplasty in primary or revision surgery.

    The patient should be skeletally mature.

    The patient's condition should be due to one or more of:

    · Severely painful and/or disabled joint: as a result of osteoarthritis, post-traumatic arthritis. rheumatoid arthritis or

    psoriactic arthritis. Congenital hip dysplasia, Ankylosing spondylitis.

    · Avascular necrosis of the femoral head.

    · Acute traumatic fracture of the femoral head or neck.

    · Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement where sufficient bone stock is present.

    Device Description

    The Versafitcup® CC Trio family of acetabular components is designed to be used with the Medacta Total Hip Prosthesis System. The Medacta Total Hip Prosthesis system includes the Quadra S, H, R, and C Stems and CoCrMo and ceramic ball heads (K072857, K073337, K080885, K082792, K083558, and K112115). The AMStem femoral stems also work with the Medacta Total Hip Prosthesis System (K093944, K103189). The Medacta Total Hip Prosthesis System is a total hip replacement system consisting of the femoral stem made of metal, a modular femoral head made of metal or ceramic, and acetabular components. The Versafitcup® CC Trio acetabular components that are the subject of this 510(k) consist of two new flat fixed liners that are made of HighCross® highly crosslinked ultra-high molecular weight polyethylene (HXUHMWPE).

    All the Versafitcup® CC Trio components are supplied sterile in single-use individual packages.

    AI/ML Overview

    The provided document is a 510(k) summary for a medical device (Versafitcup CC Trio - Additional Liners) and, as such, it focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study report with specific acceptance criteria and performance metrics typically found in clinical trials for new drug or high-risk device approvals.

    Therefore, many of the requested elements (e.g., sample size for test sets and training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone AI performance) are not applicable or not provided in this type of regulatory submission. The device is a physical medical device (hip implant liners), not a software/AI device, which explains why many of these questions about AI performance and expert review are not relevant to this document.

    Here's a breakdown of the available information:

    Acceptance Criteria and Device Performance

    Acceptance CriteriaReported Device Performance
    Mechanical Tests applicable to hip implant liners:The Versafitcup CC Trio - Additional Liners were compared to the worst-case liners of the predicate devices in regards to mechanical tests.
    - Range of MotionThe liners met the performance requirements for range of motion, as they were compared to the worst-case predicate devices and determined to introduce no new issues.
    - Instability of connection between liner and acetabular shellThe liners met the performance requirements for connection stability, as they were compared to the worst-case predicate devices and determined to introduce no new issues.
    - WearThe liners met the performance requirements for wear, as they were compared to the worst-case predicate devices and determined to introduce no new issues.
    Safety and EffectivenessThe manufacturer concluded that "the Versafitcup CC Trio - Additional Liners do not introduce any new issues in regards to safety and effectiveness" compared to the predicate devices. This implies they met the equivalent safety and effectiveness standards demonstrated by the predicate devices.

    Study Details (Based on available information)

    1. Sample size used for the test set and the data provenance: Not applicable. This is a physical device. Performance was assessed through mechanical testing, not a test set of data. The document refers to "worst-case liners of the predicate devices" for comparison.
    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device's mechanical properties is established through standardized engineering tests, not expert consensus in the clinical sense.
    3. Adjudication method for the test set: Not applicable. Mechanical tests for physical devices do not involve clinical adjudication.
    4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a physical hip implant liner, not an AI diagnostic or assistive device.
    5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical hip implant liner, not a software device.
    6. The type of ground truth used: Mechanical test results, compared against established standards or predicate device performance.
    7. The sample size for the training set: Not applicable. This is a physical device, not an AI model.
    8. How the ground truth for the training set was established: Not applicable.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1