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Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur; congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis; disability due to previous fusion; previously failed endoprostheses, and/or total hip components in the affected extremity and acute femoral neck fractures.

Hemi-hip replacement for the following: fracture dislocation of the hip; elderly, debilitated patients when a total hip replacement is contraindicated; irreducible fractures in which adequate fixation cannot be obtained; certain high subcapital fractures and comminuted femoral neck fractures in the aged; nonunion of femoral neck fractures; secondary avascular necrosis of the femoral head; pathological fractures of the femoral neck; and osteoarthritis in which the femoral head is primarily affected.

The Trabecular Metal Primary Hip Prosthesis is intended to be a single use only implant that is used to replace a hip joint.

The wedge-shaped prosthesis is designed for cementless use and is circumferentially bonded with Trabecular Metal over the proximal body region for biological fixation. The hip is offered in a broad range of sizes designed to accommodate varying patient anatomy with standard and extended neck offsets.

The provided text describes a 510(k) premarket notification for a medical device, the Trabecular Metal™ Primary Hip Prosthesis. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials to prove safety and effectiveness from scratch.

Therefore, the typical acceptance criteria and study design elements for AI/ML-based medical devices (like those involving test sets, expert ground truth, adjudication, and MRMC studies) are not applicable here. The information provided heavily focuses on regulatory details and comparison to a predicate device.

Here's a breakdown of the specific questions based on the provided document:

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

• Acceptance Criteria: For a 510(k) submission, the primary acceptance criterion is demonstrating substantial equivalence to a predicate device in terms of intended use, technological characteristics, and safety and effectiveness.
• Reported Device Performance:
  • Non-Clinical Performance: "Non-clinical testing demonstrated that the Trabecular Metal Primary Hip Prosthesis is as safe and effective as its predicate device."
  • Clinical Performance: "Clinical data and conclusions were not needed for this device."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable: This was a 510(k) submission primarily relying on non-clinical testing and comparison to a predicate device. There was no "test set" in the context of an AI/ML algorithm evaluation. The document explicitly states "Clinical data and conclusions were not needed for this device."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable: No ground truth was established by experts for a test set in this submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable: No test set or adjudication was involved for a clinical study.

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: No MRMC study was performed. The 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: The device is a physical hip prosthesis, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not Applicable: No clinical ground truth was used for a study, as clinical data was not deemed necessary for this 510(k) submission. The safety and effectiveness were primarily demonstrated via non-clinical testing and comparison to the predicate device.

8. The sample size for the training set

• Not Applicable: This is a physical medical device, not an AI/ML algorithm. There is no concept of a "training set" in this context.

9. How the ground truth for the training set was established

• Not Applicable: As above, there is no training set for this type of device.

In summary: The provided document is a regulatory submission (510(k)) for a traditional medical device (hip prosthesis). It demonstrates safety and effectiveness through non-clinical testing and substantial equivalence to a predicate device, rather than through clinical trials or performance evaluations typical for AI/ML-based devices. Therefore, most of the questions related to AI/ML study design are not relevant to this document.

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