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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.

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 Duration® II Stabilization. The purpose of the Duration® II process is to crosslink all of the free radicals found in the UHMWPE rod stock by exposure to gamma radiation followed by a stabilization process in a heated oven. During this radiation/stabilization period, the UHMWPE is exposed to a very low oxygen concentration. The stabilized rod stock is then machined to its final configuration. The tibial insert is packaged in air, and terminally sterilized by the gas plasma sterilization process. The Duracon® Condylar and A-P lipped Inserts produced by this method conform to the requirements for Ultra High Molecular Weight Polyethylene specified in ASTM Specification F-648, and the FDA quidance document on UHMWPE used in Bearing Surfaces for Orthopedic Devices. As will be discussed later, this additional style of insert demonstrated significantly less wear when compared to air irradiated UHMWPE.

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 mechanism that is identical to those Duracon® inserts which have been previously released.

The provided text describes the acceptance criteria and the study results for the Duration® II Duracon® Tibial Inserts - Gas Plasma Sterilization Device.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample size for test set: The excerpt specifically mentions a "Duracon® A-P lipped tibial insert (large, 19mm)" being tested. While it provides an average wear rate with a standard deviation, it does not explicitly state the number of samples (n) used to calculate this average for both the Duration® II and the conventionally gamma sterilized inserts.
• Data provenance: The data is described as "in vitro tests" using a "multiaxial knee joint simulator." This indicates the data is from prospective laboratory testing rather than human clinical data. The country of origin of the data is not specified, but the submission is to the FDA in the USA, implying the testing likely adheres to U.S. or international standards.

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

• This question is not applicable to this study. The "ground truth" for this device is not established by expert consensus on images or clinical outcomes, but by objective physical measurements (e.g., wear rate, material properties) conducted in a laboratory setting according to engineering standards (ASTM).

4. Adjudication method for the test set

• This question is not applicable to this study. Adjudication methods (like 2+1, 3+1) are typically used in studies where human experts are making judgments, often in medical imaging or clinical trial outcome assessment. The reported study involves direct measurement of material properties and wear in a simulator.

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

• No, a MRMC comparative effectiveness study was not done. This type of study focuses on comparing human reader performance with and without AI assistance, which is irrelevant to the evaluation of a physical orthopedic implant.

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

• This question is not applicable to this study. This device is a physical implant, not an algorithm. The "standalone performance" here refers to the physical properties and wear characteristics of the material itself, which were tested in a simulator without human intervention in the 'reading' process.

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

• The ground truth for this study is based on objective, quantitative physical measurements of material properties (e.g., conformance to ASTM F-648, gel content, tensile modulus, ESR for free radicals) and in vitro wear testing in a knee simulator.

8. The sample size for the training set

• This question is not applicable to this study. This is a direct physical device evaluation, not a machine learning model, so there is no "training set."

9. How the ground truth for the training set was established

• This question is not applicable for the same reason as above; there is no training set for a physical device evaluation.

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