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All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of Exactech Hip Systems are also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion.

• . Cemented femoral stems and cemented acetabular cups are intended for cemented fixation only.
• Press-fit femoral stems and acetabular cups are intended for press-fit fixation.
• . Femoral heads and endoprostheses are intended for use in cemented and press-fit applications.

The proposed Novation Crown Cup devices represent a modification to the predicate Novation Crown Cup cleared in K070479 and K100269. Both the predicate and proposed devices have the same intended use, general design features, and basic fundamental scientific technology. The only difference between the predicate and the proposed devices is the process by which the titanium plasma spray coating is applied.

The provided text does not describe a study involving acceptance criteria for a medical device's performance that can be presented in the requested table format.

This document is a 510(k) premarket notification for a medical device, the Exactech® Novation® Crown Cup®. It focuses on demonstrating substantial equivalence to a previously cleared predicate device, not on proving that the device meets specific performance acceptance criteria for a clinical or diagnostic task.

Here's a breakdown of why the requested information cannot be fully provided from the text:

• No specific acceptance criteria for "device performance" (as in clinical/diagnostic outcomes): The document describes a change in the manufacturing process (plasma spray coating) for an existing hip implant. The "testing" mentioned (stereological evaluation, tensile and shear testing, abrasion resistance) are engineering tests designed to ensure the physical properties and functionality of the modified coating are equivalent to the original, not to measure clinical performance metrics like sensitivity, specificity, accuracy, or other patient-centric outcomes.
• No "study" in the clinical sense: The document refers to "engineering analyses" and "engineering studies," not clinical trials or diagnostic performance studies that would involve a test set, ground truth experts, or MRMC studies.
• No AI or algorithm present: This device is a physical hip implant, not an AI/ML powered diagnostic or therapeutic device. Therefore, questions 5, 6, 8, and 9 are not applicable.

However, I can extract the information relevant to the engineering tests that were performed to support substantial equivalence:

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

• Note: The document only states that "Results of engineering studies... demonstrate the proposed Novation Crown Cup are substantially equivalent to cleared Novation Crown Cup devices." It does not provide specific numerical acceptance criteria or reported values for the engineering tests. It implies that the test results were within acceptable limits or comparable to the predicate device, thereby demonstrating substantial equivalence. The document lists the types of tests conducted, but not their specific quantitative outcomes or the thresholds for acceptance.

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

• Sample Size: Not specified in the document. Engineering tests typically use a small number of samples (e.g., 5-10 per test) for mechanical property evaluations.
• Data Provenance: Not specified, but assumed to be from Exactech's internal testing labs, likely in the USA (where Exactech Inc. is located). The studies are retrospective in the sense that they are laboratory tests performed on manufactured samples, not prospective clinical data collection.

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

• Not applicable. This involves engineering tests, not clinical diagnosis where human experts establish ground truth. Engineers/technicians would perform the tests according to standardized protocols and analyze the data.

4. Adjudication method for the test set

• Not applicable. This refers to clinical/diagnostic interpretation, not engineering test 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 device is a physical hip implant, not an AI-powered medical device.

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

• Not applicable. This device is a physical hip implant, not an algorithm.

7. The type of ground truth used

• Engineering Standards/Material Properties: The "ground truth" for these engineering tests would be established through industry standards for material properties, specified design requirements, and comparison to the previously cleared predicate device's measured properties.

8. The sample size for the training set

• Not applicable. This device is a physical hip implant. No "training set" in the context of AI/ML or statistical modeling is involved.

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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