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510(k) Data Aggregation

    K Number
    K132539
    Device Name
    RING-LOK MODULAR BIPOLAR SYSTEM
    Manufacturer
    IMPLANTS INTERNATIONAL, LTD
    Date Cleared
    2014-02-07

    (178 days)

    Product Code
    KWY
    Regulation Number
    888.3390
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K072101,K923898,K915787,K934457,K091967,K082705
    Why did this record match?
    Reference Devices :

    K072101, K923898, K915787, K934457

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

    The Ring-Lok™ Modular Bi-Polar System is intended for use in combination with other previously cleared femoral components including the Rig-Fix™ Hip Stem (K072101), C-fit Performa (K923898) or the Stability Hip Stem (K915787 and K934457) for uncemented primary or revision hemi-arthroplasty of the hip. This prosthesis may be used for the following conditions, as appropriate:

    • Femoral neck and trochanteric fractures of the proximal femur .
    • Osteonecrosis of the femoral head .
    • Revision procedures where other treatments or devices or these indications have failed.
    Device Description

    The Ring-Lok™ Modular Bi-Polar System is intended for use in combination with the previously cleared femoral components including Rig-Fix™ Hip Stem (K072101), C-fit Performa (K923898) or the Stability Hip Stem (K915787 and K934457)). The Ring-Lok™ Modular Bipolar System consists of a factory assembled UHMWPE liner in a cobalt chrome outer shell, and UHMWPE retention ring. These bipolar heads include outer diameters ranging from 38 to 62 mm, in 1mm increments, to properly fit the patient anatomy. The inner diameter mates with a 22.225, 26 or 28 mm diameter femoral head.
    Implant International supplies Ring-Lok™ Bi-Polar Instrumentation for use with the Ring-Lok™ Modular Bi-Polar System.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for the Ring-Lok™ Modular Bipolar System, based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    Test TypeAcceptance Criteria (Implied)Reported Device Performance
    Range of MotionPerformance substantially equivalent to predicate devices.Met all acceptance criteria.
    Lever OutPerformance substantially equivalent to predicate devices.Met all acceptance criteria.
    Pull OutPerformance substantially equivalent to predicate devices.Met all acceptance criteria.
    Overall PerformanceAs safe, effective, and performs as well as or better than predicate devices.Substantially equivalent to predicate devices.

    Note: The document states that the testing was "to written protocols with pre-defined acceptance criteria," but it does not explicitly list the quantitative acceptance criteria for each test beyond requiring substantial equivalence to predicate devices. The reported performance consistently states that the criteria were met.

    2. Sample Size for Test Set and Data Provenance

    • Sample Size: "worst case component size and option/design." The exact number is not specified, but it implies a focused selection of the most challenging configurations for testing.
    • Data Provenance: The testing was conducted by Implant International Limited, based in the UK. Therefore, the data provenance is likely UK-based, non-clinical (laboratory), and prospective (as it was part of design verification for this specific device).

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

    This information is not provided in the document. The testing described is non-clinical performance testing (mechanical/engineering tests), not clinical studies involving human patients or expert interpretation of clinical data. Therefore, the concept of "ground truth" established by medical experts for a test set in the usual sense does not apply here.

    4. Adjudication Method for the Test Set

    This information is not applicable/not provided. As explained above, the tests are non-clinical engineering evaluations, not clinical data requiring adjudication by experts.

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

    No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study described is a non-clinical performance test comparing the device to predicate devices through engineering evaluations.

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

    This concept is not applicable to this medical device. The "Ring-Lok™ Modular Bipolar System" is a physical implant (a hip prosthesis component), not an AI algorithm or software. Therefore, there's no "algorithm only" or "human-in-the-loop" performance to evaluate in this context. The standalone performance refers to the device itself performing its intended biomechanical function without direct human intervention during its operation in the body.

    7. Type of Ground Truth Used

    The "ground truth" in this context is the performance of established predicate devices (Medacta Bi-Polar Head K091967 and BioPro Bi-Polar Head K082705) in similar non-clinical tests, and the engineering specifications/standards that these types of devices are expected to meet. The aim was to demonstrate "substantial equivalence" to these predicates.

    8. Sample Size for the Training Set

    This information is not applicable/not provided. There is no "training set" in the context of this device's non-clinical performance testing. Training sets are relevant for machine learning algorithms, which is not what this device is.

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

    This information is not applicable/not provided for the reasons stated in point 8.

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