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510(k) Data Aggregation

    K Number
    K230078
    Device Name
    TRAX® CR Total Knee System
    Manufacturer
    Amplitude
    Date Cleared
    2023-11-03

    (297 days)

    Product Code
    JWH
    Regulation Number
    888.3560
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K113369,K193223,K161414
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The TRAX® CR Total Knee System is indicated for use:

    • In primary total knee arthroplasty (TKA) as a result of:
    • · Painful, disabling joint disease of the knee resulting from degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis.
    • · Post-traumatic loss of knee joint configuration and function.
    • Moderate varus, valgus or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.
    • In revision of previous osteotomy,
    • In revision of previous unsuccessful unicompartimental or femoro-patellar knee.
      The TRAX® CR Total Knee System is for single use only and is intended for implantation with bone cement only.
    Device Description

    The TRAX® CR Total Knee System belongs to the category of Cruciate Retaining (CR) total knee prostheses (only anterior-cruciate is sacrificed).
    The TRAX® CR Total Knee System is intended for use as a semi-constrained replacement system. It consists of a femoral component, a tibial implant and a patellar component. The tibial implant consists of two components: bearing insert and tibial baseplate. The patellofemoral joint may be preserved or resurfaced with the patellar resurfacing implant.
    The selection of the appropriate implants can be made by using the recommendations of the surgical technique and by using the x-ray templates and trial implants supplied with the instrumentation.

    AI/ML Overview

    The provided document is a 510(k) premarket notification for the TRAX® CR Total Knee System. This type of notification focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive clinical study data and performance metrics against specific acceptance criteria like those often seen for AI/ML devices or novel technologies.

    Therefore, many of the requested details about acceptance criteria, device performance tables, sample sizes, expert ground truth, MRMC studies, standalone performance, and training set information are not applicable to this specific document or the type of regulatory submission it represents.

    However, I can extract the information that is present and indicate where the requested information is not provided.

    TRAX® CR Total Knee System: Substantial Equivalence Summary

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (Bench Test Standard)Reported Device Performance (Summary)
    ASTM F1814-15 (Disassembly forces)Testing conducted according to FDA guidance documents.
    ASTM F1223-20 (Tibio-femoral constraint)Testing conducted according to FDA guidance documents.
    ASTM F2083-20 (Tibio-femoral contact stresses)Testing conducted according to FDA guidance documents.
    ISO 14243-1 (2009) (Tibio-femoral wear)Testing conducted according to FDA guidance documents.
    ASTM F1800-19 (Baseplate fatigue)Testing conducted according to FDA guidance documents.
    ASTM F1223-20 (Patello-Femoral Constraint)Testing conducted according to FDA guidance documents.
    ASTM F2083-21 (Patello-Femoral contact area stress)Testing conducted according to FDA guidance documents.
    ASTM F1800-19 (Stem interlock strength)Testing conducted according to FDA guidance documents.
    ASTM F2759-19 (Characterization of AXPE polyethylene)Testing conducted according to FDA guidance documents.
    ASTM F2052-2021 (MRI compatibility testing)Testing conducted according to FDA guidance documents.
    ISO 10993 (Biocompatibility testing)Testing conducted according to FDA guidance documents.
    [Implicit: Substantial Equivalence]"Amplitude considers the TRAX CR Total Knee System to be substantially equivalent to the predicate devices listed above. This conclusion is based upon the devices' similarities in principles of operation, technology, materials and indications for use."

    Explanation: The "acceptance criteria" here are the recognized FDA/international standards for mechanical and material testing of total knee systems. The "reported device performance" is a general statement indicating that testing was conducted per FDA guidance and that the device meets the criteria for substantial equivalence, implying it performed acceptably against these standards when compared to the predicate devices. Specific quantitative results are not provided in this summary.

    2. Sample Size Used for the Test Set and Data Provenance

    • Sample Size: Not applicable. This document refers to non-clinical bench testing, not clinical studies with patients. The sample sizes for the various mechanical and material tests (e.g., number of components tested for fatigue, wear, etc.) are implicitly defined by the referenced ASTM and ISO standards but are not explicitly reported in this summary.
    • Data Provenance: Not applicable. The data comes from bench testing, not patient data from a specific country or collected retrospectively/prospectively.

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

    • Not applicable. This is a non-clinical submission. Ground truth for bench testing is established by the design of the test method and instrumentation to measure physical properties according to established standards.

    4. Adjudication Method for the Test Set

    • Not applicable. This is a non-clinical submission.

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

    • No. An MRMC study was not done. This type of study is typically for evaluating diagnostic or interpretive devices with human readers, which is not the case for a knee implant. The document explicitly states: "Clinical data and conclusions were not needed for this device."

    6. Standalone (Algorithm Only) Performance Study

    • Not applicable/No. This is a physical medical device (knee implant), not an algorithm or software-only device.

    7. Type of Ground Truth Used

    • For the non-clinical testing, the "ground truth" is based on engineering specifications and measurements conforming to the referenced ASTM and ISO standards. This includes properties like material strength, wear resistance, disassembly forces, and constraint.

    8. Sample Size for the Training Set

    • Not applicable. This is a physical medical device. The "training" in this context refers to the design and manufacturing process, which is established through engineering and quality control procedures, not through a 'training set' of data like in machine learning.

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

    • Not applicable. As above, this is a physical device. The device's design and manufacturing rely on established engineering principles, material science, and quality management systems (like 21 CFR Part 820), rather than a ground truth established for a data training set.
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