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Total hip replacement is indicated in the following conditions:

1. A severely painful and/or disabled joint from osteoarthritis, rheumatoid arthritis, or congenital hip dysplasia.
2. Avascular necrosis of the femoral head.
3. Acute traumatic fracture of the femoral head or neck.
4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, surface replacement arthroplasty, or total hip replacement.
5. Certain cases of ankylosis.

Partial hip replacement is indicated in the following conditions:

1. Acute fracture of the femoral head or neck that cannot be appropriately reduced and treated fixation.
2. Fracture dislocation of the hip that cannot be appropriately reduced and treated with internal fixation.
3. Avascular necrosis of the femoral head.
4. Non-union of femoral neck fractures.
5. Certain high subcapital and femoral neck fractures in the elderly.
6. Degenerative arthritis involving only the femoral head in which the acetabulum does not require replacement.
7. Pathology involving only the femoral head/neck and/or proximal femur that can be adequately treated by hip hemiarthroplasty.

The EMPHASYS Femoral Stems include HA-coated femoral stems in standard and high offsets and in collared and collarless configurations. The EMPHASYS Femoral Stems are designed to be used as one component of a system of prostheses in hip arthroplasty. The stems are compatible with a DePuy modular metal, dual mobility, or ceramic femoral head, and either a one-piece or a metal-backed two-piece acetabular component for use in total hip arthroplasty, and with a modular unipolar metallic femoral head or a modular bipolar head construct for hemi-hip arthroplasty.

The provided document is a 510(k) summary for a medical device (EMPHASYS Femoral Stems) and primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. It explicitly states that no clinical tests were conducted to demonstrate substantial equivalence.

Therefore, I cannot provide the information requested in your prompt regarding acceptance criteria, study details (sample size, data provenance, expert involvement, adjudication, MRMC studies, standalone performance), or ground truth establishment for a study proving device performance against specified acceptance criteria.

The document discusses performance in terms of non-clinical tests for mechanical properties and biocompatibility. Here's a breakdown of what is present in the document related to "performance data" and "acceptance criteria" in a non-clinical context:

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)

Regarding the study that proves the device meets acceptance criteria (for clinical performance):

The document explicitly states: "No clinical tests were conducted to demonstrate substantial equivalence."

Therefore, the following information cannot be provided from this document:

• 2. Sample size used for the test set and the data provenance: Not applicable as no clinical test set was used.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• 4. Adjudication method for the test set: Not applicable.
• 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 hip implant, not an AI-assisted diagnostic tool.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• 7. The type of ground truth used: Not applicable for clinical performance. For non-clinical tests, the ground truth is established by the specified ISO/ASTM standards and internal compliance.
• 8. The sample size for the training set: Not applicable as no clinical study with training data was conducted.
• 9. How the ground truth for the training set was established: Not applicable.

In summary, this 510(k) submission relies on non-clinical performance data and a comparison of technological characteristics to a legally marketed predicate device to establish substantial equivalence, rather than a clinical study demonstrating performance against specific clinical acceptance criteria.

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