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510(k) Data Aggregation

    K Number
    K980925
    Device Name
    DURATION II TIBIAL INSERTS-ETHYLENE OXIDE STERILIZATION
    Manufacturer
    HOWMEDICA CORP.
    Date Cleared
    1998-12-16

    (280 days)

    Product Code
    JWH
    Regulation Number
    888.3560
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    DURATION II TIBIAL INSERTS-ETHYLENE OXIDE STERILIZATION

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

    The Intended use of this additional style of Duracon® Condylar and A-P lipped tibial inserts is identical to that of previously released Duracon® tibial inserts: they are intended to be used with Duracon® femoral and patellar components, and tibial baseplates in primary or revision cemented total knee arthroplasty.

    Device Description

    The purpose of this submission is to describe an additional style of Duracon® Condylar and A-P lipped tibial inserts which are stabilized/sterilized using a process called and A-1 "Ilpped tible incorro the Duration® II process is to crosslink all of the free radicals found in the UHMWPE rod stock by exposure to gamma radiation this froo radio lound lount in a heated oven. During this radiation/stabilization period, the UHMWPE is exposed to a very low oxygen concentration. The stabilized periou, the United to its final configuration. The tibial insert is packaged in air, and terminally sterilized by the ethylene oxide sterilization process. The Duracon® and terminally ottomized by this method conform to the requirements for Ultra High Molecular Weight Polyethylene specified in ASTM Specification F-648, for Okla Figh Molocation on UHMWPE used in Bearing Surfaces for Orthopedic Devices.

    These Duracon® Condylar and A-P lipped inserts are identical to those previously released. They are available in peripheral sizes extra-small through extra-large in thicknesses from 6mm to 25mm. These inserts have a three point locking in thisklesson from on on on one Duracon® inserts which have been previously released.

    AI/ML Overview

    The provided text is a 510(k) summary for a medical device (Duration® II Duracon® Tibial Inserts) and does not describe artificial intelligence performance or a study comparing AI to human readers. Therefore, I cannot extract the requested information about AI acceptance criteria, device performance, sample sizes, ground truth establishment, or multi-reader, multi-case studies.

    The document focuses on demonstrating substantial equivalence of a new style of tibial inserts to previously marketed versions, primarily through material property testing and comparison of intended use.

    Here's a breakdown of what the document does provide, although it doesn't align with the AI-centric questions:

    1. A table of acceptance criteria and the reported device performance:

    Acceptance CriteriaReported Device Performance
    Products meet all ASTM F 648 specified standards.Duration® II products meet all ASTM F 648 specified standards.
    No detectable oxidation as measured by FTIR up to 30 days of accelerated aging at 80° C in air.Duration® II products have no detectable oxidation as measured by FTIR up to 30 days of accelerated aging at 80° C in air.
    Higher gel content (cross-linking) than air irradiated UHMWPE measured in accordance with modified ASTM D2765-90 standard.Duration® II products have a higher gel content (cross-linking) than air irradiated UHMWPE measured in accordance with modified ASTM D2765-90 standard.
    Lower tensile modulus than air irradiated UHMWPE, increasing contact area and decreasing contact stress.Duration® II has a lower tensile modulus than air irradiated UHMWPE. This would increase in contact area and a decrease in contact stress.
    No free radicals detected in the final product when analyzed by the ESR technique.No free radicals are detected in the Duration® II material when analyzed by the ESR technique of the final product.

    2. Sample sized used for the test set and the data provenance: Not applicable. The document discusses material testing, not a dataset for an AI model.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" here is defined by material standards (ASTM F-648, ASTM D2765-90) and analytical methods (FTIR, ESR) for which expert consensus in the AI sense is not relevant.

    4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Material testing results are objective measurements against defined standards.

    5. 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 not an AI device.

    6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI device.

    7. The type of ground truth used: Material property standards (ASTM F-648, ASTM D2765-90) and analytical measurements (FTIR, ESR).

    8. The sample size for the training set: Not applicable. There is no training set for an AI model.

    9. How the ground truth for the training set was established: Not applicable. There is no training set for an AI model.

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