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The PCA® Primary Inserts for Duracon® Baseplates (K936008), PCA® Modular Inserts for Duracon® Baseplates (K940861), PCA® Modular Primary/Revision Patella (K940713), Duracon® Recessed Patella (K951655), Duracon® Inset Patella with Central Peg (K961482), Duracon® All Poly Patella II (K961483), Duracon® Extra Small Tibial Stabilizer Insert (K970758), Kinematic® All Poly Patella with Three Pegs (K971550), and the Kinematic® II Replacement Tibial Inserts (K960976) are intended was a to be used with the PCA®, Duracon®, or Kinemax® family of femoral components, tibial baseplates, and patellar components in primary or revision cemented total knee arthroplasty.

This submission describes additional UHMWPE Knee components that have been previously cleared for sterilization by the Duration® Stabilized process and are to be added to the list of devices cleared for the corresponding wear claims in submission K965173. The additional products are described below, as are the wear claims from K965173.

The products that have been added to the list of devices cleared for the wear claims are: The PCA® Primary Inserts for Duracon® Baseplates (K936008), PCA® Modular Inserts for Duracon® Baseplates (K940861), PCA® Modular Primary/Revision Patella (K940713), Duracon® Recessed Patella (K951655), Duracon® Inset Patella with Central Peg (K961482), Duracon® All Poly Patella II (K961483), Duracon® Extra Small Tibial Stabilizer Insert (K970758), Kinematic® All Poly Patella with Three Pegs (K971550), and the Kinematic® II Replacement Tibial Inserts (K960976). These components are intended to be used with the PCA®, Duracon®, or Kinemax® family of femoral components, tibial baseplates, and patellar components in primary or revision cemented total knee arthroplasty.

The provided text describes wear claims for Howmedica's Duration® Stabilized UHMWPE Knee Components based on in vitro laboratory tests. The document repeatedly states that "The results of in vitro tests have not been shown to correlate with clinical wear mechanisms," which is a crucial disclaimer when interpreting the data.

Here's a breakdown of the requested information based on the provided text, with clarifications where the information is not directly available:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state "acceptance criteria" in the traditional sense of a predetermined threshold that the device must meet to be considered effective. Instead, it presents wear claims as observed reductions in volumetric wear compared to a conventional material. The "acceptance criteria" are implied by the reported reductions themselves, showcasing the improved performance of the stabilized UHMWPE.

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

The document describes the test samples rather than a "test set" in the context of a statistical study with a specific sample size (N). The tests involved specific physical samples:

• Reciprocating ring-on-block test: "A block of Howmedica's Duration® Stabilized UHMWPE" and "the same block of Howmedica's conventionally gamma sterilized UHMWPE." This implies a comparison between two samples (one stabilized, one conventional).
• Independent pin-on-disk tests: "a 9mm thick circular disk of Howmedica's Duration® Stabilized UHMWPE" and "the same circular disk of Howmedica's conventionally gamma sterilized UHMWPE" (for both the unaged and aged comparisons). This also implies a comparison between two samples for each test.

Sample Sizes: For each test described, the comparison appears to be one-to-one, comparing a stabilized sample directly against a conventional sample. The total number of individual samples tested across all three scenarios would be small (e.g., 2 blocks, 4 disks).

Data Provenance: The data is generated from in vitro laboratory tests.

• The first test (ring-on-block) is described as being performed internally ("Howmedica's Duration® Stabilized UHMWPE").
• The second and third tests (pin-on-disk) are explicitly stated as being performed in "an independent laboratory test."

The country of origin is not specified, but Howmedica Inc. is based in Rutherford, New Jersey, USA. The data is retrospective in the sense that the tests were conducted prior to this 510(k) submission, but it's not "retrospective clinical data."

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

N/A. This is a technical performance study of materials (wear testing) and does not involve human interpretation or subjective assessment of physiological conditions. Therefore, there is no "ground truth" established by experts in the medical diagnostic sense. The ground truth for volumetric wear is established by the physical measurement methods used in the laboratory tests.

4. Adjudication Method for the Test Set

N/A. As this is a physical wear testing study, there is no team of human adjudicators reviewing output. The "adjudication" is inherent in the standardized measurement protocols of the wear tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This document describes in vitro wear testing of materials, not a clinical study involving human readers or cases. Therefore, an MRMC comparative effectiveness study was not performed, and there is no effect size related to human reader improvement with AI.

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

N/A. This is not an AI/algorithm-based device. It is a physical medical device (UHMWPE knee components) whose performance is evaluated through mechanical in vitro tests.

7. The Type of Ground Truth Used

The ground truth used is physical measurement of volumetric wear. This is determined by the methodologies of the reciprocating ring-on-block and pin-on-disk wear tests, which are standardized engineering and materials science techniques.

8. The Sample Size for the Training Set

N/A. This is not an AI/machine learning device; therefore, there is no concept of a "training set" in the context of an algorithm. The UHMWPE material itself is a product of manufacturing processes, and its inherent properties (including resistance to wear) are determined by its formulation and stabilization process.

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

N/A. As there is no training set for an algorithm, there is no ground truth established for it.

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