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The DePuy Universal Femoral Metaphyseal Sleeve and Universal Stem components are intended for use with the PFC, Sigma PFC, Sigma TC3 Revision Knee, or S-ROM knee prostheses 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. These devices are intended for cemented use only.

The DePuy Universal Femoral Metaphyseal Sleeve and Universal Stem components are also intended for use with the DePuy LPS prosthesis for replacement of the mid-shaft portion of the femur, proximal, distal and/or total femur, and proximal tibia, especially in cases that require extensive resection and replacement. Specific diagnostic indications for use include: Malignant tumors (e.g., osteosarcomas, chondrosarcomas, giant cell tumors, bone tumors) requiring extensive resection and replacement; patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g. avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis, requiring extensive resection and replacement; revision for failed previous prosthesis cases requiring extensive resection and replacement; severe trauma requiring extensive resection and replacement. The LPS prosthesis is also intended for use in bone loss postinfection, where the surgeon has elected to excise the bone and replacement is required.

The Universal Stem and the Universal Metaphyseal Sleeve components are intended for cemented use only.

DePuy is offering the DePuy Universal Femoral Metaphyseal Sleeve and the DePuy Universal Stem Extenstion components as line extensions to its previously cleared PFC, PFC Sigma, S-ROM, Sigma TC3 Revision Knee and Limb Preservation System (LPS) knee replacement prostheses systems. These additional components are designed to be interchangeable within these four knee systems.

The DePuy Universal Femeral Metaphyseal Sleeve components are a modification to the design of the previously cleared DePuy LPS Metaphyseal Sleeve included in K040281. The Universal Femoral Metaphyseal Sleeve components are available in five sizes. They are also available in nonporous textured finish, fully porous coated and distally porous coated options. The femoral metaphyseal sleeve components are optional components that attach to the femoral knee prostheses components by a taper locking mechanism. Use of adapter components are required for the attachment of the metaphyseal sleeve component to the PFC Sigma, LPS and Sigma TC3 femoral components. The metaphyseal sleeve attaches directly to the S-ROM femoral component. The threaded distal female portion of the femoral metaphyseal sleeve component receives the male threaded portion of the Universal Stem Extension to provide a stemmed femoral knee prosthesis construct. An optional polyethylene plug component is assembled to the metaphyseal sleeve.

The Universal Stem Extension component is an optional component available in three lengths and eight diameters. The distal portion of the stem extension below the male threaded portion is fluted and terminates in a bullet shaped tip. The stem extension component is perpendicularly quadrifurcated to allow for flexibility of the stem component under physiologic loads. The two smallest component diameters are solid. The DePuy Universal Stem Extension components are a modification to the design of the stem extension components previously cleared in K941769. These components can be attached to the female threaded portion of the Universal Femoral Metaphyseal Sleeve or may be attached without the sleeve to the PFC Sigma and Sigma TC3 femoral components using the adapters. The sleeve component is required for the LPS and S-ROM femoral components. The same male threaded attachment is used to connect the stem extensions to the tibial tray components from the PFC, PFC Sigma and Sigma TC3 Revision knee prosthesis systems. The stem extension in not used for the S-ROM tibial trays.

The Universal Stem and Universal Femoral Metaphyseal Sleeve are both manufactured from Ti6-A14-V alloy. The porous coating on the Universal Femoral Metaphyseal Sleeve is comprised of sintered microbeads of commercially pure (CP) titanium.

It appears the provided document is a 510(k) premarket notification for universal stem extensions and universal femoral metaphyseal sleeves for knee prosthesis systems. This document does not describe a study to prove the device meets acceptance criteria in the way typically expected for a diagnostic AI or software device. Instead, it demonstrates substantial equivalence to previously cleared predicate devices.

Therefore, many of the requested categories (like acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training set details) are not applicable or cannot be extracted from this type of regulatory submission. The concept of "acceptance criteria" here relates more to the regulatory standard of substantial equivalence for medical devices rather than performance metrics for an AI algorithm.

However, I can provide information based on the premise of substantial equivalence as outlined in the document:

1. Table of Acceptance Criteria and Reported Device Performance

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

Not applicable. This is a 510(k) submission for mechanical devices based on substantial equivalence to existing devices, not a performance study using a "test set" of data in the context of AI or diagnostic algorithms. The demonstration of equivalence relies on design comparisons, material specifications, and intended use as described, rather than statistical performance against a dataset.

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

Not applicable. This is not a study requiring expert consensus or ground truth establishment in the context of diagnostic performance. The ground truth for device safety and effectiveness is established through regulatory standards for manufacturing, materials, and design, and comparison to legally marketed predicate devices.

4. Adjudication Method for the Test Set

Not applicable. There was no "test set" or adjudication process in the sense of reviewing diagnostic outcomes.

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 is a submission for knee prosthesis components, not an AI or diagnostic software device that would involve human readers or AI assistance.

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

Not applicable. This is for mechanical knee prosthesis components, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" in this context is the regulatory acceptance of the safety and effectiveness of the predicate devices (DePuy LPS Knee System K040281 and S-ROM/Noiles™ PS Total Knee System K941769). The new devices establish their "truth" by demonstrating substantial equivalence to these legally marketed and accepted predicate devices in terms of intended use, materials, and design.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" for mechanical device substantial equivalence.

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

Not applicable. There is no "training set" for mechanical device substantial equivalence. The "ground truth" for the predicate devices' acceptance would have been established through their own respective 510(k) clearances or pre-amendment status, based on regulatory evaluation of their design, materials, manufacturing, and clinical performance data (if required for their clearance).

Summary regarding the 510(k) process:

This document demonstrates that the Universal Stem Extensions and Universal Femoral Metaphyseal Sleeves are "substantially equivalent" to predicate devices already on the market. This is the primary "acceptance criterion" for a 510(k) premarket notification. The study, in this case, is the comparison and detailed description of the new device's design, materials, and intended use against those of the predicate devices. This type of submission relies on the established safety and effectiveness of the predicate devices.

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