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1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
2. Rheumatoid arthritis
3. Correction of functional deformity
4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
5. Revision of previously failed total hip arthroplasty.

The subject devices, Distal Centralizers, are cylindrical components designed to slide onto the distal end of a cemented femoral stem prior to insertion into the femoral canal.

The provided text describes a 510(k) premarket notification for "Distal Centralizers" (K193546). This document is primarily focused on demonstrating substantial equivalence to a predicate device, specifically regarding a change in the bioburden reduction process. It is not a study proving device performance against acceptance criteria in the typical sense of a human-AI comparative study or a standalone algorithm performance study.

Therefore, many of the requested fields cannot be answered directly from this document because it's not a study about AI or human reader performance.

Here's an analysis based on the information available:

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

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

This document does not specify the sample size for the "Non-Clinical Tests" performed, nor does it provide information on data provenance. The tests are focused on the device itself (sterilization, shelf life, biocompatibility, geometry), not data from patients or users.

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. This is not a study requiring expert interpretation of results or establishment of ground truth in a clinical sense. The "ground truth" (or rather, the reference standards) for sterilization, biocompatibility, and geometric evaluations would be established through established scientific and engineering principles and testing protocols.

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

Not applicable. There is no mention of adjudication as this is not a study involving human interpretation or subjective assessment of clinical data.

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

No. An MRMC comparative effectiveness study was not done. The device (Distal Centralizers) is a physical medical implant, not an AI or imaging system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm or AI device. The "standalone" performance here would refer to the physical and material performance of the centralizers themselves under the new manufacturing process, which was evaluated through non-clinical testing.

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

For the non-clinical tests described:

• Sterilization: Ground truth is established by validated sterilization protocols and tests (e.g., sterility testing, bioburden reduction validation) that adhere to international standards.
• Shelf life: Ground truth is established by accelerated aging or real-time shelf life studies using accepted methodologies.
• Biocompatibility: Ground truth is established by standard biocompatibility testing protocols (e.g., ISO 10993 series) against a known safe biological response.
• Geometric Evaluation: Ground truth is established by engineering specifications and design tolerances.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable. This is not an AI/machine learning device that requires a training set.

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