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510(k) Data Aggregation

    K Number
    K990849
    Device Name
    DURATION IV STERILIZATION PROCESS (ACETABULAR INSERTS)
    Manufacturer
    HOWMEDICA OSTEONICS CORP.
    Date Cleared
    1999-12-20

    (280 days)

    Product Code
    LPH,JDI
    Regulation Number
    888.3358
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The intended use of the additional styles of the System 12®, Omnifit®, & Trident™ acetabular inserts is identical to that of previously released inserts: they are intended to be used with their respective acetabular shells in primary or revision total hip arthroplasty.

    Device Description

    The purpose of this submission is to describe additional styles of System 120 Acetabular, Omnifit® and Trident™ Acetabular Inserts which are sterilized/ stabilized using a process called Duration® IV Stabilization. The purpose of the Duration® IV process is to minimize (through crosslinking) the free radicals found in the UHMWPE rod stock by exposure to gamma radiation followed by a stabilization process in a heated oven. The stabilized rod stock is then machined to its final configuration. The components are packaged in air, and terminally sterilized by either Gas Plasma or Ethylene Oxide sterilization. The components produced by this method conform to the requirements for Ultra High Molecular Weight Polyethylene specified in ASTM Specification F-648, and the FDA guidance document on UHMWPE used in Bearing Surfaces for Orthopedic Devices.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for the Duration® IV Sterilization/Stabilization Process, based on the provided text:

    Acceptance Criteria and Reported Device Performance

    Acceptance Criteria ClaimReported Device Performance
    1. Duration® IV products meet all ASTM F-648 specified standards.The components produced by this method conform to the requirements for Ultra High Molecular Weight Polyethylene specified in ASTM Specification F-648.
    2. Duration® IV products have no detectable oxidation as measured by FTIR up to 23 days of accelerated aging at 80℃ in air.No specific reported device performance value is given, but the claim explicitly states "no detectable oxidation."
    3. Duration® IV products have a higher cross-linking density than air irradiated UHMWPE measured in accordance with modified ASTM D2765-90 standard.No specific reported device performance value is given, but the claim explicitly states "higher cross-linking density."
    4. Duration® IV has a lower tensile modulus than air irradiated UHMWPE. This lower stiffness has demonstrated an increase in contact area and a decrease in contact stress.No specific reported device performance value is given, but the claim explicitly states "lower tensile modulus," "increase in contact area," and "decrease in contact stress."
    5. No free radicals are detected in the Duration® IV material when analyzed by the ESR technique of the final product.No specific reported device performance value is given, but the claim explicitly states "No free radicals are detected."
    6. Duration® IV has a 91% lower wear rate, as measured by hip wear simulation testing under non-abrasive conditions, than UHMWPE that is gamma sterilized in an inert atmosphere.Average total wear of 22.8 ± 13.7 mm³ for Duration® IV compared to 258.8 ± 39.7 mm³ for control UHMWPE (gamma sterilized in inert atmosphere). This represents a 91% lower wear rate for Duration® IV. Testing was performed in a multiaxial hip joint simulator for 5.0 million cycles using a 32 mm CoCr head articulating counterface against a 4.8 mm thickness polyethylene insert with bovine calf serum as lubricant.
    7. Duration® IV has a 98% lower wear rate, as measured by hip wear simulation testing under abrasive conditions, than UHMWPE that is gamma sterilized in an inert atmosphere.Average total wear of 2.2 ± 2.2 mm³ for Duration® IV compared to 89.9 ± 4.0 mm³ for control UHMWPE (gamma sterilized in inert atmosphere). This represents a 98% lower wear rate for Duration® IV. Testing was performed in a multiaxial hip joint simulator for 3.5 million cycles using a 32 mm CoCr head articulating counterface against a 4.8 mm thickness polyethylene insert with bovine calf serum as lubricant and PMMA bone cement particles as the abrasive media.

    Study Details:

    The provided document describes physical and mechanical testing of the Duration® IV Sterilization/Stabilization Process and its resultant products (Acetabular Inserts). It does not describe a clinical study involving human patients or the evaluation of an AI-powered device. Therefore, many of the requested fields are not applicable to the provided information.

    1. Sample size used for the test set and the data provenance:

      • Sample Size: Not explicitly stated as a numerical 'sample size' for each test. For wear simulation (Claims 6 & 7), the statistical reporting includes standard deviations (e.g., 22.8 ± 13.7 mm³), implying multiple test repetitions. However, the exact 'n' for these tests or for other criteria like FTIR, ESR, or tensile modulus is not provided.
      • Data Provenance: The studies are retrospective in vitro laboratory bench tests on the material. The country of origin for the data is not specified, but the submission is to the US FDA by Howmedica Osteonics Corp., which has its contact in Rutherford, NJ, USA.

    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

      • N/A: As this is a materials science and engineering study involving laboratory testing, "experts" in the context of clinical ground truth (e.g., radiologists) are not applicable. The measurements themselves serve as the 'ground truth' for the material properties.

    3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

      • N/A: Adjudication methods like 2+1 are relevant for clinical studies with subjective interpretations (e.g., imaging reads). This is a laboratory testing scenario where direct measurements are taken.

    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:

      • No: This is a materials science study, not a study evaluating human reader performance with or without AI.

    5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

      • N/A: Not applicable, as this is not an algorithm or AI device.

    6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

      • The "ground truth" for the acceptance criteria are direct physical and chemical measurements of the material's properties (e.g., wear rate, oxidation detection, cross-linking density, tensile modulus, free radical detection) using established ASTM standards and laboratory techniques (FTIR, ESR, hip wear simulation).

    7. The sample size for the training set:

      • N/A: There is no "training set" as this is not a machine learning or AI algorithm.

    8. How the ground truth for the training set was established:

      • N/A: Not applicable, as there is no training set.
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