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The Sigma Cruciate Retaining Porocoat Femoral Components are intended for cemented or cementless use as the femoral components of a Total Knee Replacement system.

Total Knee Replacement is intended to provide increased patient mobility and reduced pain by replacing the damaged knee joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.

Candidates for total knee replacement include elderly patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or a failed previous implant. Total knee replacement may be considered for younger patients if, in the opinion of the surgeon, an unequivocal indication for total knee replacement outweighs the risks associated with the age of the patient, and if limited demands regarding activity and knee joint loading can be assured. This includes severely crippled patients with multiple joint involvement for whom a gain in knee mobility may lead to significant improvement in their quality of life.

The Sigma C/R Porocoat Femoral Components are part of the Sigma Total Knee Replacement System. They are porous coated Co-Cr femoral components with an asymmetric trochlear groove, available in sizes 1.5- 6, in right and left versions. Fixation of the femoral component to the femur is achieved using either bone cement or by biologic fixation via tissue ingrowth into the porous coating.

The provided text is a 510(k) summary for the DePuy Sigma Cruciate Retaining (C/R) Porocoat® Femoral Components. This document focuses on demonstrating substantial equivalence to previously cleared devices, rather than presenting a study with specific acceptance criteria and performance metrics for a novel technology.

Therefore, many of the requested elements (acceptance criteria, device performance tables, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance studies, etc.) are not applicable or not present in this type of submission.

Here's why and what information can be extracted:

• This is a 510(k) submission for substantial equivalence. In a 510(k) pathway, the primary goal is to show that a new device is as safe and effective as a legally marketed predicate device. This is often done by demonstrating similarity in design, materials, indications for use, and technological characteristics. It does not typically involve extensive clinical performance studies with acceptance criteria in the same way a PMA or a novel AI/software device would.
• The device is an orthopedic implant (Total Knee Replacement Prosthesis). For such devices, substantial equivalence is commonly established through a comparison of physical and mechanical properties, sterilization methods, biocompatibility, and intended use, often leveraging existing data from the predicate device.
• The key argument for substantial equivalence is based on existing, cleared components. The DePuy Sigma C/R Porocoat Femoral Components are described as:
  • "identical in design to the Sigma Femoral Components cleared for cemented use only in K943462 and K961685." (Predicate 1 & 2 for design)
  • "The Porocoat porous coating... is identical to the Porocoat porous coating used on the LCS Knee Femoral Components, which were approved for cementless use in P830055 and on the AML Proximally Coated Hip cleared for cementless use in K933787." (Predicate 3 & 4 for the Porocoat feature and cementless use).

Given this context, here's an attempt to address your points, indicating where information is not available:

Acceptance Criteria and Study Overview

This 510(k) submission does not present a study with specific, quantifiable "acceptance criteria" and "reported device performance" in the way one would see for a diagnostic device or an AI algorithm. Instead, the "study" is a comparative analysis demonstrating substantial equivalence to predicate devices, focusing on design, materials, and technological characteristics. The "acceptance criteria" are implied by the FDA's decision to clear the device based on the submission's arguments for similarity to existing devices.

1. Table of Acceptance Criteria and Reported Device Performance

Not Applicable. This submission does not provide a table of acceptance criteria and reported device performance metrics because it's a substantial equivalence argument, not a performance study against novel criteria. The "performance" is inferred to be equivalent to the predicate devices due to identical design and materials.

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

Not Applicable. No explicit "test set" or human subject data is described for this specific submission. Substantial equivalence for this type of device relies on engineering comparisons, material analysis, and referencing existing predicate device data.

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

Not Applicable. Ground truth, in the context of device performance studies, is not applicable here as no clinical "test set" requiring expert evaluation is mentioned. The "truth" for substantial equivalence is based on the technical specifications and regulatory history of the predicate devices.

4. Adjudication Method for the Test Set

Not Applicable. No multi-expert adjudication method is described as there is no "test set" requiring such evaluation.

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. This device is a passive implant (knee component), not an AI-powered diagnostic or assistive tool. MRMC studies are not relevant here.

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

Not Applicable. This is a physical orthopedic implant, not an algorithm.

7. The Type of Ground Truth Used

"Ground truth" for this 510(k) is implicitly based on the established safety and effectiveness of the legally marketed predicate devices. The submission argues that because the new device's design (K943462, K961685) and surface coating (P830055, K933787) are identical to components already cleared by the FDA, its safety and effectiveness are also equivalent.

8. The Sample Size for the Training Set

Not Applicable. This is not an AI/ML device requiring a training set.

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

Not Applicable. This is not an AI/ML device requiring a ground truth for a training set.

In summary, the K062654 submission is a classic example of a 510(k) premarket notification for demonstrating substantial equivalence of a medical device (a knee implant component) to existing predicate devices. It relies on direct comparison of design, materials, and indications for use, rather than presenting de novo clinical performance studies with acceptance criteria commonly seen for diagnostic or AI-driven devices.

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