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The DePuy ASR™ Modular Acetabular Cup System is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.

The DePuy ASR Taper Sleeve Adapter mates with the ASR Femoral Heads (K040627) and any 11/13 or 12/14 DePuy femoral stem to provide differing offsets to best match the patient's anatomy.

The provided text is a 510(k) summary for the DePuy ASR™ Hip Taper Sleeve Adapter. This document is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device, rather than a study demonstrating the device meets specific performance acceptance criteria through clinical or scientific studies.

Therefore, the input does not contain information for the following:

1. A table of acceptance criteria and the reported device performance: This document does not detail specific performance criteria or report on performance against those criteria.
2. Sample size used for the test set and the data provenance: No test set or data provenance is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: There is no mention of experts or ground truth establishment.
4. Adjudication method: No adjudication method is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No MRMC study is mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: This is a physical medical device, not an algorithm.
7. The type of ground truth used: No ground truth is established as this is not a diagnostic device.
8. The sample size for the training set: No training set is mentioned.
9. How the ground truth for the training set was established: No training set or ground truth for it is mentioned.

The document primarily focuses on establishing substantial equivalence based on:

• Intended Use and Indications for Use: The "ASR™ Hip Taper Sleeve Adapter" is intended to mate femoral heads to femoral stems, offering various offsets and compatibility, and its indications for use are tied to the "DePuy ASR™ Modular Acetabular Cup System" for total hip replacement in patients with various conditions causing severe pain and disability.
• Similarity to Predicate Devices: The basis of substantial equivalence is stated as similarity in intended use, indications for use, materials, and design to the "DePuy ASR™ Modular Acetabular Cup System Sleeve Adapters, K040627" and the "DePuy Ultima Unipolar Head and Sleeve Adapters, K965156".

In summary, this document is a regulatory submission demonstrating substantial equivalence, not a study reporting on specific performance acceptance criteria for a new device.

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