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The BIOCERAM AZUL HEAD is a single use modular femoral head component for use in hip arthroplasty procedures for the following indications:

• Painful disabling joint disease of the hip resulting from: degenerative arthritis, rheumatic arthritis or late stage avascular necrosis,

• Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure,

• Clinical management problems where arthrodesis or alternative techniques are less likely to achieve satisfactory results.

The BIOCERAM AZUL HEAD (the modified device) is identical to the unmodified predicate device in materials, taper system, articulating surface, packaging, sterilization and shelf life, but it differs from the unmodified predicate device in size variation. Labels are different only in reference to the model number and size.

The modified device is manufactured from the same high purity alumina matrix with zirconia reinforcement, which complies with ISO 6474-2. Two additional sizes (outer diameters) will be offered: 22 mm and 26 mm. There are 2 offsets (+0, +3 mm) for the 22 mm size and 2 offsets (+0, +3.5 mm) for the 26 mm size; and the current 28 mm head will be offered in an additional offset of +7 mm. These new ODs and offsets are the same or similar to those of the Metal Heads also cleared by K160895.

The provided document is a 510(k) summary for a medical device called BIOCERAM AZUL® HEAD. It outlines the device description, indications for use, and a discussion of substantial equivalence to a predicate device. However, it does not contain any information about an AI/ML-based device.

Therefore, I cannot provide an answer that includes:

• A table of acceptance criteria and reported device performance for an AI/ML device.
• Sample size used for an AI/ML test set or data provenance.
• Number/qualifications of experts for AI/ML ground truth.
• Adjudication method for an AI/ML test set.
• MRMC comparative effectiveness study results for AI assistance.
• Standalone performance for an AI/ML algorithm.
• Type of ground truth used for an AI/ML study.
• Sample size for AI/ML training set.
• How ground truth for AI/ML training set was established.

The document focuses on the mechanical and material equivalence of a ceramic femoral head component for hip arthroplasty, based on bench testing (e.g., static compression burst test, static pull-off test, static torsion test) against ISO and ASTM standards.

The "Non-Clinical Performance Data" section does describe the study that proves the device meets acceptance criteria, but these criteria are for physical properties of a medical implant, not the performance of an AI/ML algorithm.

Summary of Device Performance and Acceptance Criteria (from the provided text, not related to AI/ML):

The device is a non-AI/ML medical implant with acceptance criteria related to its mechanical and material properties. The study conducted to prove the device meets these criteria involved bench testing.

1. Table of acceptance criteria and the reported device performance:

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

• Sample Size: Not explicitly stated in the provided text. Bench testing typically uses a defined number of physical samples per test.
• Data Provenance: The tests were conducted internally by KYOCERA Corporation in accordance with internal procedures and international standards. This suggests laboratory data, not clinical patient data. The country of origin of the data is not specified beyond "KYOCERA Corporation" being located in Japan.
• Retrospective or Prospective: Not applicable, as this refers to physical bench testing, not data collection from patients over time.

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

• Not applicable as this pertains to the performance of a physical implant being tested against international engineering standards, not human interpretation of medical images or data. The "ground truth" is established by the specifications and pass/fail criteria of the referenced ISO/ASTM standards.

4. Adjudication method for the test set:

• Not applicable. The testing involves objective measurements against engineering standards, not human-based adjudication.

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 device is a physical medical implant, not an AI/ML diagnostic or assistive tool.

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

• Not applicable. This is not an algorithm.

7. The type of ground truth used:

• The ground truth for this device's performance is the adherence to specified mechanical and material properties as defined by international standards (ISO 6474-2, ISO 7206-10, ISO 7206-13, ASTM F2345).

8. The sample size for the training set:

• Not applicable. This device does not use a "training set" in the context of machine learning.

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

• Not applicable.

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