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The PMMA Distal Centralizers are intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
2. inflammatory degenerative joint disease such as rheumatoid arthritis:
3. correction of functional deformity; and,
4. revision procedures where other treatments or devices have failed
   The PMMA Distal Centralizers are single use components, intended for use as part of a cemented total hip arthroplasty.

The PROFEMUR® X" Wingless Distal Centralizer and PERFECTA® Distal Centralizer are molded PMMA centralizers placed within the femoral canal before the hip stem implant, providing a guide for the implant and allowing the surgeon to easily center the hip stem implant within a uniformly thick cement mantle. The centralizer bears no body weight, since the cured bone cement transfers all loading forces from the stem to the bone. The materials used for the Distal Centralizers are identical to the materials used for the predicate devices (molded PMMA), but unlike the predicate the replacement will not contain any additives.

The provided 510(k) summary does not describe an AI medical device. It pertains to PROFEMUR® X™ Wingless Distal Centralizer and PERFECTA® Distal Centralizer, which are physical medical devices (molded PMMA centralizers for hip stem implants).

Therefore, the specific information requested in the prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, and MRMC studies, which are typically associated with AI/ML device evaluations, is not applicable to this document.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices through comparisons of:

• Intended Use and Indications for Use
• Technological Characteristics (materials, function)
• Nonclinical Testing (mechanical testing, material analysis, cytotoxicity)

Key points from the document regarding the device's assessment:

• Acceptance Criteria/Performance: The device is considered to have met acceptance criteria if it is "substantially equivalent" to predicate devices. The document concludes that the PROFEMUR® X™ Wingless Distal Centralizer and PERFECTA® Distal Centralizer are equivalent to predicate devices and are capable of withstanding expected in vivo conditions without failure based on nonclinical testing.
• No Clinical Testing: The document explicitly states, "Clinical data was not provided for the centralizers." This means no human subject studies were conducted to assess the device's performance in a clinical setting.
• Ground Truth: For a physical device like this, "ground truth" isn't established in the same way as for AI. Instead, it relies on established material science standards and mechanical testing to demonstrate that the device performs as intended and is safe.
• Study Type: This is a nonclinical study focused on material characterization and mechanical performance to demonstrate substantial equivalence to legally marketed predicate devices.

Summary of what can be extracted from the document in relation to the prompt's categories (with N/A where not applicable):

Acceptance Criteria and Device Performance (Non-AI Device)

Study Information (as requested by prompt, but adapted for this non-AI device context)

1. Sample size used for the test set and the data provenance: Not applicable in the context of an AI device. For this physical device, specific N values for experimental samples in mechanical and material tests are not provided in the summary. The tests are nonclinical, performed in a lab setting.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Material and mechanical properties are evaluated against established ASTM standards and comparable predicate device data, not expert consensus on interpretations.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This is a nonclinical device assessment.
4. 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 not an AI device.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI device.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For this physical device, "ground truth" relates to adherence to material specifications (e.g., ASTM F451), measured mechanical properties (compressive strength), and biochemical analyses (e.g., residual monomer, cytotoxicity) which are compared to predicate devices and recognized safety thresholds.
7. The sample size for the training set: Not applicable. This is not an AI device.
8. How the ground truth for the training set was established: Not applicable. This is not an AI device.

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