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• Noninflammatory degenerative joint disease (NIDJD) including avascular necrosis, osteoarthritis, post-traumatic arthritis and congenital hip dysplasia and inflammatory joint disease (IJD), e.g. rheumatoid arthritis if bone quality is adequate.
• Failed previous surgery where pain, deformity, or dysfunction persists.
• Revision of previously failed hip arthroplasty.
• Total hip replacements may be considered for younger patients if any unequivocal indication outweighs the risks associated with the age of the patient and modified demands regarding activity and hip joint loading are assured. This includes severely handicapped patients with multiple joint involvement, for whom an immediate need of hip mobility leads to an expectation of significant improvement in the quality of their lives.
• The system is intended for use either with or without bone cement in total hip arthroplasty.

The Metasul Taper Liner and Femoral Heads are composed of CoCrMo alloy. The outer diameter of the liner is machined with a locking taper feature that mates with the interior Continuum and Trilogy IT acetabular shell's taper. The Metasul Taper Liners are designed for use only with Metasul Femoral Heads.

The provided document describes a premarket notification (510(k)) for the Metasul® Taper Liner and Metasul Femoral Heads, which are components of a Total Hip Prosthesis. The document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a standalone study with detailed performance metrics.

Therefore, much of the requested information (acceptance criteria table, sample sizes for test/training sets, number of experts, adjudication methods, MRMC study details, etc.) is not present in the provided text.

However, I can extract the following relevant information:

1. Acceptance Criteria and Reported Device Performance:

The document states that the device met "performance requirements" and is "as safe and effective as their predicates." This is a qualitative statement of equivalence rather than a quantitative performance metric against specific acceptance criteria.

2. Sample size used for the test set and data provenance:
* Test Set Sample Size: Not specified.
* Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The document mentions "Clinical data demonstrates the safety and effectiveness" but does not elaborate on the study design or data collection.

3. Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable, as no dedicated "test set" and "ground truth" establishment by experts in the context of an AI/algorithm study are described. The document pertains to a medical device approval, not an AI evaluation.

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 is a medical device clearance, not an AI efficacy study.

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 component, not an algorithm.

7. The type of ground truth used: Not explicitly stated. For medical device approvals like this, "ground truth" is typically established through a combination of:
* Predicate Device Performance: The primary method here is demonstrating substantial equivalence to devices already on the market.
* Non-Clinical Testing: "Non-Clinical testing demonstrated that the Metasul Taper liners and Metasul Femoral Heads met performance requirements." This would involve mechanical testing, wear testing, etc., against predefined standards for hip prostheses.
* Clinical Data: "Clinical data demonstrates the safety and effectiveness of the subject device." This would refer to patient outcomes from clinical trials or post-market surveillance. The specific nature of "clinical data" (e.g., patient follow-up, symptom reports, imaging results) is not detailed.

8. The sample size for the training set: Not applicable. This is a medical device, not an AI model.

9. How the ground truth for the training set was established: Not applicable.

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