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The BIOLOX delta Ceramic Femoral Heads are modular components used in total hip arthroplasty and are indicated for the following:
• Patients suffering from severe hip pain and disability due to rheumatoid arthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur.
• Patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis.
• Patients suffering from disability due to previous fusion; patients with previously failed endoprostheses and/or total hip components in the operative extremity.
• Patients with acute femoral neck fractures.

The BIOLOX OPTION Ceramic Femoral Head System is comprised of modular components used in primary or revision total hip arthroplasty and is indicated for the following:
• Patients suffering from severe hip pain and disability due to rheumatoid arthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur.
• Patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis.
• Patients suffering from disability due to previous fusion.
• Patients with previously failed endoprostheses and/or total hip components in the operative extremity.
• Patients with acute neck fractures.

The BIOLOX delta Ceramic Femoral Heads are fabricated from an alumina matrix composite and are available in diameters of 28, 32, 36, and 40mm with a range of offsets to accommodate various patient anatomies. They serve as an alternative to both metal and alumina ceramic femoral heads for use in total hip arthroplasty.

The BIOLOX OPTION Ceramic Femoral Head System consist of a ceramic head fabricated from an alumina matrix composite available in diameters of 28, 32, 36, and 40 mm and a titanium adapter for the femoral stem cone with a range of offsets to accommodate various patient anatomies. The system serves as an alternative to both metal and alumina ceramic femoral heads and is for use in both primary and revision total hip arthroplasty.

This appears to be a 510(k) summary for a medical device (BIOLOX Delta Ceramic Femoral Heads and BIOLOX Option Ceramic Femoral Head System), not a study describing acceptance criteria and performance of a device based on AI/ML or image analysis. The document focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, primarily through engineering analyses and material equivalence, rather than a clinical study with a test set, ground truth, or human reader involvement.

Therefore, many of the requested fields cannot be extracted directly from this document as they are not applicable to this type of regulatory submission. This document does not describe an AI/ML-based device that would typically have the requested performance metrics.

However, I can extract information related to the performance data presented within the context of a 510(k) submission for mechanical/material equivalence.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

2. Sample size used for the test set and the data provenance

• Not Applicable in the way implied by the request for an AI/ML study.
• The performance data relies on engineering analyses and material testing, not a "test set" of clinical cases or images. The "samples" would refer to test articles/components used in the mechanical and material tests. The document does not specify the number of individual components tested but refers to the completion of the tests.
• Data Provenance: The tests are likely conducted in a controlled laboratory environment by the manufacturer or a third-party testing facility, adhering to specified ISO/ASTM standards. The country of origin of these tests is not explicitly stated but would typically be where the manufacturer (Zimmer GmbH, Switzerland) conducts or commissions such testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable in the way implied by the request for an AI/ML study.
• This device is a mechanical implant. "Ground truth" in this context would refer to the validated standards and specifications (e.g., ISO standards) used for material and mechanical properties, not expert consensus on clinical cases. The interpretation of test results would be done by engineers and scientists (who are experts in their field) in accordance with these standards.

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

• Not Applicable. Adjudication methods like 2+1 or 3+1 are used for establishing clinical ground truth, especially with image interpretation. For mechanical testing, adherence to standardized test protocols and data analysis governs the results.

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 mechanical implant device, not an AI/ML diagnostic aid that involves human readers interpreting cases.

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

• Not Applicable. This is a mechanical implant device, not an AI/ML algorithm.

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

• For this type of device, the "ground truth" (or reference standard) is primarily international standards and specifications (e.g., ISO, ASTM) for mechanical properties, material composition, and performance under specific simulated conditions (like wear and range of motion). There is no "pathology" or "outcomes data" ground truth directly described for the performance testing in this summary for substantial equivalence.

8. The sample size for the training set

• Not Applicable. This is a mechanical implant device, not an AI/ML algorithm, so there is no "training set."

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

• Not Applicable. No training set exists for this type of device.

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