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The Duracon®, P.C.A.® and Kinemax® Plus Tibial Inserts, All Plastic Tibial Components and Patellar Components (proviously cleared in K915512, K923573, K910235, K922048, K932070, K913188, K872735, K871772 and K921640) are intended to be used with Duracon®, P.C.A.® or Kinemax® femoral components, tibial baseplates and patellar components in primary or revision cemented total knee arthroplasty.

This submission includes wear testing data on UHMWPE Knee Components sterilized by the method previously cleared in 510(k) submission K936292. This data is provided to substantiate claims of improved wear due to the processing of the devices. The submission includes Duracon®, P.C.A.® and Kinemax® Plus Tibial Inserts, All Plastic Tibial Components and Patellar Components which are intended to be used with Duracon®, P.C.A.® or Kinemax® Plus femoral components, tibial baseplates and patellar components in primary or revision cemented total knee arthroplasty.

This submission details the wear testing of Howmedica's Duration™ Stabilized UHMWPE Knee Components to substantiate claims of improved wear. The study compares the wear performance of the stabilized UHMWPE against conventionally gamma sterilized UHMWPE in various in vitro wear tests.

Here is an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The submission does not explicitly state pre-defined acceptance criteria in numerical terms (e.g., "must show at least X% reduction"). Instead, the reported device performance is the claim being substantiated, implying that any measured reduction in wear would be considered a positive outcome. The FDA's substantial equivalence determination suggests acceptance of these claims.

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

• Sample Size: The document refers to "a block" and "a 9mm thick circular disk" for the unaged tests, and "a 9 mm thick circular disk" for the aged test, both for the Duration™ Stabilized UHMWPE and the conventionally gamma sterilized UHMWPE for comparison. This phrasing suggests a sample size of one test article for each condition (stabilized vs. conventional, unaged vs. aged) for each type of test. However, wear testing typically involves multiple samples to ensure reproducibility and statistical significance. The limited detail provided here implies either a single sample per comparison or a simplified reporting of the outcome from multiple samples.
• Data Provenance: The tests were conducted as "in vitro tests" in an "independent laboratory test." The country of origin is not specified but is presumably the USA, given the FDA 510(k) submission. The data is prospective in the sense that these were controlled experiments specifically designed to test the wear properties.

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

Not applicable. This study involves in vitro mechanical wear testing, not a clinical study or diagnostic device assessment where expert opinion would establish ground truth. The "ground truth" for wear is established by the measured weight loss or volume displacement during the mechanical tests.

4. Adjudication Method for the Test Set

Not applicable. This is an in vitro mechanical test, not a clinical review requiring adjudication. The measurements of wear are objective.

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

No, an MRMC comparative effectiveness study was not done. This study is an in vitro mechanical wear test of materials, not a diagnostic imaging study involving human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done

Yes, in a way. The tests performed are standalone in the sense that they are material property tests performed in a lab setting, independent of human interaction once initiated. There is no "algorithm" in the context of AI, but the measurements of wear are objective outcomes of the material's performance under simulated conditions.

7. The Type of Ground Truth Used

The ground truth used is measured volumetric wear. This is an objective measurement obtained through laboratory testing (reciprocating ring-on-block wear test and reciprocating pin-on-disk wear evaluations) using established scientific methods (weight loss to calculate volume change, or direct volume measurement if applicable).

8. The Sample Size for the Training Set

Not applicable. This study does not involve a "training set" in the context of machine learning or AI algorithms. It is an in vitro study of material properties.

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

Not applicable, as there is no training set for an AI algorithm in this context.

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The Duracon® Femoral Posterior Spacer is intended to be used with the femoral components of the Duracon® Total Knee System (reference premarket notifications K910235, K920034, K932070, and K954138) to augment bone loss in the area of the posterior condyle of the femur. Posterior bone loss that requires augmentation by spacers may be noted in primary or revision total knee arthroplasty cases.

The Duracon® Femoral Posterior Spacer is cemented to the femoral component, and then the spacer-femoral component assembly is cemented into place.

The provided 510(k) summary for the Duracon® Femoral Posterior Spacer Device (K963242) is a premarket notification for a medical device. This type of document is filed with the FDA to demonstrate that a medical device is substantially equivalent to a legally marketed predicate device.

It is important to understand that 510(k) summaries, especially from 1996, typically do not contain the type of detailed performance criteria and study results that would be found in a current regulatory submission for an AI/ML-based diagnostic device. The regulatory landscape and expectations for evidence of performance have evolved significantly since 1996, particularly concerning software as a medical device and AI.

Therefore, most of the requested information regarding acceptance criteria and detailed study data (like sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance of an algorithm) is not present in the provided text. The device described is a physical implant, not an AI diagnostic tool.

Below is an attempt to answer your questions based only on the provided text, acknowledging its limitations for an AI/ML context:

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

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable / Not Provided. The document does not describe a "test set" in the context of an AI/ML study. Clinical data or testing that would typically be described with sample sizes, provenance, or retrospective/prospective nature is not included in this 510(k) summary for a physical implant. The basis for clearance is substantial equivalence to predicates, not specific clinical trial data described here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable / Not Provided. This information is relevant for validating diagnostic algorithms, not for the clearance of a physical orthopedic implant. No ground truth establishment by experts for a "test set" is mentioned.

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

• Not Applicable / Not Provided. See response to question 3.

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 / Not Provided. This device is a physical knee implant component, not an AI system or an aid for human interpretation. Therefore, an MRMC study related to AI assistance is not relevant or described.

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

• Not Applicable / Not Provided. This device is a physical product, not an algorithm.

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

• Not Applicable / Not Provided. Given this is a physical implant, "ground truth" for its performance would implicitly relate to its mechanical properties, biocompatibility, and clinical outcomes (e.g., in vivo stability, wear characteristics, patient function). However, these are not quantified or discussed as "ground truth" in this summary. The primary "ground truth" for its regulatory acceptance is its substantial equivalence to predicate devices, which have already demonstrated appropriate safety and effectiveness.

8. The sample size for the training set

• Not Applicable / Not Provided. The concept of a "training set" is for AI/ML models. This document refers to a physical device.

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

• Not Applicable / Not Provided. See response to question 8.

Summary of Limitations:

The provided document (K963242) is a 1996 510(k) summary for an orthopedic implant. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed clinical study data or performance metrics using methodologies common for AI/ML devices in today's regulatory environment. Therefore, most of the questions, particularly those pertaining to AI/ML validation (test sets, training sets, expert consensus, adjudication, MRMC studies), cannot be answered from the given text.

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