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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.

Novation Element press-fit femoral stems with HA coating are intended for press-fit fixation.

The proposed Exactech Novation Element Press-Fit Femoral Stem is a modification of the HA Coated MCS Total Hip System cleared through premarket notification #K990197 and 12/14 Acumatch Press-Fit Femoral Stem cleared through premarket notification #K041906.

The predicate and proposed devices have the same intended use and basic fundamental scientific technology and share the following similarities:

• the same indications for use
• the same basic design features
• incorporate the same materials
• the same shelf life
• are packaged and sterilized using the same materials and processes

The only modifications to the technological characteristics of the predicate devices are:

• The trapezoidal cross-sectional geometry of the shaft has been slightly altered.
• Horizontal grooves have been added to the shaft.

Standard orthopedic instrumentation (FDA class I) is used for implantation of the Novation Element Press-Fit Femoral Stem. These press-fit femoral components are designed such that an interference condition is created between the implant and host bone.

The provided text describes a Special 510(k) Premarket Notification (K080980) for the Exactech Novation Element Press-Fit Femoral Stem. This type of submission is for modifications to previously cleared devices where the new device is substantially equivalent to existing predicate devices.

Based on the provided information, the concept of "acceptance criteria" and a "study proving the device meets acceptance criteria" as typically understood for AI/ML performance metrics (e.g., sensitivity, specificity, AUC) is not applicable here.

Here's why and what the document does provide:

• Device Type: This is for a mechanical orthopedic implant (femoral stem for hip replacement), not an AI/ML diagnostic or predictive device.
• Regulatory Pathway (Special 510(k)): For physical medical devices, a Special 510(k) focuses on demonstrating substantial equivalence to a predicate device through engineering evaluations, material testing, and design comparisons, rather than clinical performance trials with specific AI-like metrics.

Therefore, many of the requested fields regarding AI/ML performance, ground truth, expert opinions, and training/test sets are irrelevant to this specific document.

I will attempt to answer the relevant questions based on the provided text, and mark those that are not applicable (N/A) for this type of device and submission.

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 (N/A): This is a mechanical device, and performance is demonstrated through engineering testing and design comparisons, not a clinical "test set" in the context of diagnostic AI/ML. The "testing and engineering evaluations" would involve material strength, fatigue, and geometric analysis, not patient data for a test set.

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

• Not Applicable (N/A): Ground truth for a test set is not applicable here as this is not an AI/ML diagnostic device nor a clinical study generating patient-specific ground truth. The evaluation rests on engineering and material science principles.

4. Adjudication method for the test set

• Not Applicable (N/A): No test set or human adjudication process is described for this mechanical device.

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 (N/A): This is for a mechanical implant, not an AI-assisted diagnostic tool. Therefore, an MRMC study and effects on human readers are not relevant.

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

• Not Applicable (N/A): This is for a mechanical implant, not software or an algorithm.

7. The type of ground truth used

• Not Applicable (N/A): For this device, "ground truth" would be established through engineering specifications, material standards, and biomechanical principles, not clinical outcomes or expert consensus in the typical AI/ML sense. The "substantial equivalence" framework means the predicate devices' long-term performance in implant use serves as a baseline.

8. The sample size for the training set

• Not Applicable (N/A): This device does not involve a "training set" as it is not an AI/ML product.

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

• Not Applicable (N/A): This device does not involve a "training set" or "ground truth" in this context.

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