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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 Novation LPI Prime Femoral Stems are being re-branded as the Alteon Neck Preserving Femoral Stems.

The Alteon Neck Preserving Femoral Stems Sizes 6 and 7 are titanium press-fit prostheses featuring a 12/14 trunnion that is used on the femur side of a total or hemi hip arthroplasty. The proximal region of the stem is coated with titanium plasma sprayfor uncemented, biological fixation.

The proposed femoral stems are intended to mate with the following modular 12/14 femoral heads:

• . Exactech Cobalt Chromium Alloy Femoral Heads (K041906)
• Exactech Ziramic Zirconia Femoral Heads (K050398, K060107)
• Exactech BIOLOX® forte Alumina Femoral Heads (K023964, K051682) ●
• Exactech BioloxDelta and DeltaOption Femoral Heads and Adapters . (K103012)
• AcuMatch L-series Unipolar endoprostheses (K010081) ●

The proposed Alteon Neck Preserving Femoral Stems Sizes 6 and 7are line extensions to the Novation LPI Prime Femoral Stems cleared in K121684. Both the predicate and proposed devices have the same intended use, general design features, and basic fundamental scientific technology. The proposed Alteon Neck Preserving Femoral Stems Sizes 6 and 7use the femoral neck geometry as the previously cleared Novation LPI Prime Femoral Stem Size 5.

The provided text describes the Exactech® Alteon™ Neck Preserving Femoral Stems Sizes 6 and 7, which are titanium press-fit prostheses for hip arthroplasty. The device is a "Special 510(k)" submission, indicating it's a modification of a previously cleared device. Therefore, the "study" proving acceptance is primarily based on engineering analyses rather than clinical trials with human subjects.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly defined as pass/fail thresholds in a table within the document. Instead, the "acceptance criteria" are implied by demonstrating substantial equivalence to a predicate device through engineering analyses. The "reported device performance" is framed in terms of the results of these analyses showing equivalence.

Overall Conclusion: "Results of engineering studies referenced in this 510(k) submission demonstrate the proposed Alteon Neck Preserving Femoral Stems Sizes 6 and 7 are substantially equivalent to cleared Novation LPI Prime Femoral Stem devices." This implies that the engineering analyses successfully showed the new device met the performance characteristics expected and exhibited no new safety or efficacy concerns compared to the predicate. |

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not applicable. This submission relies on engineering analyses rather than a clinical "test set" of patient data or samples. The testing involves simulations and calculations on the device designs.
• Data Provenance: Not applicable. Since it's an engineering analysis, there isn't data provenance in the sense of patient origin. The analyses are based on the design specifications of the device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• Number of Experts: Not applicable. Ground truth for an engineering analysis of mechanical equivalence is typically established by engineering standards, validated simulation tools, and established theoretical models, not by human experts interpreting clinical data.
• Qualifications of Experts: N/A

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. There is no clinical test set or human interpretation requiring an adjudication process. The engineering analyses follow validated methodologies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

• MRMC Study: No. This is not an AI-powered diagnostic device, but a medical implant. Therefore, MRMC studies and AI assistance metrics are not relevant or applicable.

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

• Standalone Performance: Not applicable. This is not an algorithm or AI system. Its performance is evaluated through material science and biomechanical engineering principles.

7. The Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" for this submission is based on established engineering principles, validated simulation models (e.g., Finite Element Analysis), and the performance characteristics of the legally marketed predicate device (Exactech Novation LPI Prime Femoral Stem - K121684). The goal is to demonstrate that the new sizes maintain the safety and effectiveness profile established by the predicate.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This is not a machine learning device and therefore does not have a "training set" in the computational sense. The "training" here would be the accumulated engineering knowledge and technical data related to similar implants.

9. How the Ground Truth for the Training Set was Established

• How Ground Truth for Training Set was Established: Not applicable. As described above, there is no "training set." The understanding of implant performance comes from historical data, biomechanical research, material science, and regulatory standards developed over time for orthopedic devices.

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