Search Results

The Sigma XLK Tibial Inserts are intended for use in total knee replacement surgery for patients suffering from severe pain and disability due to permanent structural damage resulting from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, pseudogout, trauma or failed prior surgical intervention.

The DePuy Sigma XLK Tibial Inserts are posterior lipped, cruciate retaining or stabilized tibial inserts with the same design and intended use as the tibial inserts cleared in K033272. The subject inserts are manufactured from XLK Crossfinked Polycthylene. The Sigma XLK Tibial Inserts are intended for use with the Sigma Co-Cr Tibial Trays previously cleared in K032151, and the Darwin femoral components, previously cleared in K943462.

The provided document is a 510(k) premarket notification for a medical device (DePuy Sigma XLK Tibial Inserts) and focuses on demonstrating substantial equivalence to predicate devices, primarily through mechanical wear testing. It does not contain information about a clinical study involving human readers or the components typically found in such a study (like acceptance criteria for diagnostic accuracy, expert review, training sets, etc.).

However, I can extract the information provided regarding the mechanical wear performance.

Acceptance Criteria and Study for DePuy Sigma XLK Tibial Inserts

The study described is an in-vitro knee simulator wear test, not a clinical study involving human readers or diagnostic performance. The "acceptance criteria" here relate to the wear performance of the device compared to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states: "The results of in-vitro wear tests have not been shown to correlate with clinical wear mechanisms." This is an important disclaimer.

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

• Test Set (Wear Test):
  • DePuy Sigma XLK Tibial Inserts: n = 3 (Size 3, 10mm cruciate retaining)
  • Johnson & Johnson Darwin (PFC Sigma) Tibial Inserts (predicate): n = 6 (Size 3, 10mm cruciate retaining)
• Data Provenance: The data is from an in-vitro knee simulator wear study conducted by the manufacturer, DePuy Orthopaedics, Inc. (USA). This is a laboratory-based study, not a clinical study involving human patients or data from a specific country of origin in the context of clinical outcomes.

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

This information is not applicable to this document. The study described is an in-vitro mechanical wear test, not a study requiring expert consensus for a ground truth.

4. Adjudication Method for the Test Set

This information is not applicable to this document, as there was no expert review or adjudication in this in-vitro mechanical study.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This document focuses on the mechanical performance and substantial equivalence of a medical implant, not the diagnostic efficacy of an imaging device or AI algorithm.

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

Not applicable. This document is about a knee implant, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" in this context is the measured gravimetric wear of the tibial inserts under controlled laboratory conditions using a knee joint simulator, based on physical material loss.

8. The Sample Size for the Training Set

Not applicable. This study is not an AI algorithm study and therefore has no training set.

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

Not applicable. As there is no training set mentioned, there is no ground truth to establish for it in this context.

Ask a specific question about this device