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The DePuy Total Elbow System is indicated to reduce pain and improve the function and mobility of the affected joint in patients with a painful arthritic joint due to osteoarthritis, rheumatoid arthritis, or post traumatic arthritis and pathological fractures of the distal humerus in which adequate bone stock exists for the fixation of prosthetic components.

Total Elbow replacement may be considered for younger patients, if, in the opinion of the surgeon, an unequivocal indication for elbow replacement outweighs the risks associated with the age of the patient , and if limited demands regarding activity and elbow joint loading can be assured. This included patients for whom an immediate gain of elbow mobility may lead to an expectation of significant improvement in the quality of their lives.

The DePuy Total Elbow System is intended for cemented use only.

The DePuy Total Elbow System is designed to be implanted as either an unlinked (semiconstrained) or linked (constrained) elbow. When the DePuy Total Elbow System is implanted as an unlinked elbow it relies on existing soft tissues, such as the medial collateral ligament and triceps tendon for support and stability. While the linked system is held together with the linked ulnar component and pin assembly, and is used when there is poor bone stock.

The DePuy Total Elbow System humeral stems are available in 100, 150, and 200mm lengths. The ulnar stems available in two lengths 60 and 80mm lengths, right and left, to accommodate different patient anatomy. Both the humeral and ulnar stems are intended for use with bone cement.

The provided text, K992656, is a 510(k) summary for the DePuy Total Elbow System, submitted to the FDA in 1999. This document is a premarket notification for a medical device and, as such, does not contain information about a study that proves the device meets specific acceptance criteria related to its performance in patients or comparative effectiveness with AI assistance.

The purpose of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, not necessarily to prove its clinical effectiveness through detailed studies and acceptance criteria as one might find in an AI medical device submission nowadays.

Therefore, I cannot provide the information requested for acceptance criteria and a study that proves the device meets those criteria, a multi-reader, multi-case study, or standalone algorithm performance. The document focuses on establishing equivalence based on design, materials, indications for use, and manufacturing processes.

However, I can extract information related to the device description and the basis for its substantial equivalence:

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

Based on the provided document, there are no specific performance acceptance criteria or reported performance data in the context of clinical outcomes or diagnostic accuracy from a study included. The "performance" described relates to the design of the device:

No specific quantitative or qualitative acceptance criteria beyond the product description and intended use are explicitly stated or supported by a study within this 510(k) summary.

2. Sample size used for the test set and the data provenance: Not applicable. No test set or clinical study data are presented in this 510(k) summary for performance evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No test set or ground truth establishment is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set or adjudication is described.

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 an elbow prosthesis, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an elbow prosthesis, not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. No ground truth is described in the context of a performance study. The 510(k) relies on the "ground truth" of existing similar devices demonstrating safe and effective performance over time.

8. The sample size for the training set: Not applicable. No training set is described.

9. How the ground truth for the training set was established: Not applicable. No training set or ground truth establishment is described.

Summary of 510(k) Basis for Equivalence:

The document states that the substantial equivalence of the DePuy Total Elbow System is substantiated by its similarity in:

• Indications for use
• Design
• Materials
• Sterilization
• Packaging

to the following predicate devices:

• DePuy Mark II Elbow (K872084)
• Capitello-Condylar Total Elbow (K983141)

The determination of substantial equivalence was based on a detailed device description and conformance with voluntary performance standards (though the specific standards are not listed in the provided text). This indicates that the "study" demonstrating performance is primarily regulatory compliance and comparison to previously approved devices, rather than a prospective clinical trial.

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