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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 Exactech Novation Element Press-Fit Femoral Stems are a modification of the Exactech Novation Element Press-Fit Femoral Stems cleared through premarket notification #K080980.

The predicate and proposed devices have the same intended use and the same basic fundamental scientific technology.

The modified devices share the following similarities with predicate devices:

• The same design features (e.g. stem geometry, femoral head taper design, stem . insertion feature)
• The same materials (titanium alloy, hydroxyapatite coating) .
• The same shelf life (5 years), and ●
• Are packaged and sterilized using the same materials and processes (gamma . radiation sterilization to a sterility assurance level of 10°).

This submission proposes expanding the scope of Novation Element femoral stems by adding new components with modified neck geometry and adding alternative coating suppliers.

The provided document is a 510(k) summary for a medical device (Exactech® Novation® Element Press-Fit Femoral Stem), which is a premarket notification to the FDA. This type of document is used to demonstrate substantial equivalence to a predicate device, not to present a study proving the device meets acceptance criteria in the way a diagnostic or AI-driven device might.

Therefore, the requested information categories (such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details) are not applicable to this kind of submission. The "acceptance criteria" here refer to the regulatory criteria for demonstrating substantial equivalence, not performance metrics from a clinical or diagnostic study.

Here's an interpretation based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable (N/A). This is a 510(k) submission for a physical orthopedic implant. The "testing" refers to engineering and material characterization, not patient data sets. The "test set" in the context of device performance in humans or with AI algorithms does not apply.

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

• N/A. Ground truth from experts is relevant for diagnostic performance evaluation, not for demonstrating substantial equivalence of a physical implant's mechanical properties or design.

4. Adjudication method for the test set:

• N/A. Adjudication methods are used in studies involving human interpretation or data analysis, not for the engineering tests described here.

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:

• N/A. This device is a passive orthopedic implant, not an AI-driven or diagnostic tool. MRMC studies are irrelevant.

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

• N/A. This refers to AI algorithm performance evaluation, which is not applicable to an orthopedic implant.

7. The type of ground truth used:

• N/A (in the typical sense of "ground truth" for diagnostic studies). The "truth" in this context is established through engineering principles, material science standards, and comparison to the predicate device's known characteristics. For example, "fatigue strength equivalent to other legally marketed femoral stems" is a comparative engineering truth, not a clinical ground truth.

8. The sample size for the training set:

• N/A. No training set is used as this is not a machine learning or AI device.

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

• N/A. No training set or associated ground truth.

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