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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.

Addition of 36 mm outside diameter size femoral head components in three different head lengths (-3.5, 0 +3.5 mm)

The provided text describes a 510(k) Special Modification for the Exactech AcuMatch 12/14 Press-Fit Femoral Stems, specifically the addition of 36mm outside diameter size femoral head components. This is a submission for a medical device and not for a software or AI-driven device. Therefore, the traditional "acceptance criteria" and "study" framework as it applies to software performance (such as sensitivity, specificity, or reader studies) is not applicable here.

Instead, the "acceptance criteria" for this device modification are related to its mechanical performance and substantial equivalence to existing predicate devices.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a "test set" in the context of clinical data or patient samples as it is not a clinical study of a diagnostic device. The "testing" refers to empirical (mechanical/engineering) testing and engineering analyses. The sample size for these tests (e.g., number of femoral heads tested for fatigue) is not provided. Similarly, no data provenance (country, retrospective/prospective) is relevant or mentioned, as this is pre-market device testing, not a clinical trial.

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

This concept is not applicable. "Ground truth" in this context would implicitly refer to the established engineering standards and biomechanical principles used to design and evaluate orthopedic implants. The "experts" involved would be the engineering team at Exactech, potentially external consultants, and regulatory reviewers at the FDA. Their specific number or qualifications for establishing biomechanical "ground truth" are not mentioned, but it's implicit that they possess relevant engineering and medical device expertise.

4. Adjudication Method for the Test Set

This concept is not applicable for mechanical testing. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in expert interpretations of clinical data or images. For device performance testing, the results are typically quantitative and objective measurements against predefined engineering specifications.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices, not for a physical orthopedic implant modification.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone algorithm performance study was not done. This concept is specific to AI/software performance.

7. The Type of Ground Truth Used

The "ground truth" for this device modification is based on:

• Engineering Analyses: Biomechanical principles, material science, and established orthopedic design standards.
• Empirical Testing Data: Results from mechanical tests (e.g., fatigue, static strength, wear) designed to simulate in vivo conditions and evaluate the integrity and durability of the implant components.
• Predicate Device Performance: The established safety and effectiveness of the existing Exactech 12/14 Alumina Femoral Heads (K032964) serves as a benchmark and "ground truth" for substantial equivalence.

8. The Sample Size for the Training Set

This concept is not applicable. This is not an AI/machine learning device that requires a "training set."

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

This concept is not applicable.

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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.

AcuMatch M-Series 12/14 Neck Segments and Exactech 12/14 Alumina Femoral Heads are intended to be used in press-fit and cemented applications.

Exactech 12/14 Alumina Femoral Heads: Design changes to the proposed BIOLOX® forte 12/14 Ceramic Femoral Heads relative to Exactech's predicate Zirconia Ceramic Femoral Heads (#K914574, #K931617). The modifications include a change in the ceramic material composition from zirconia to alumina and a change in the taper geometry from a proprietary 11/13 design to a European 12/14 design. The proposed Ceramic Femoral Heads are composed of CeramTec BIOLOX® forte alumina material and have a European 12/14 bore design.

AcuMatch M-Series 12/14 Neck Segments: Modification of the AcuMatch M-Series neck segments (#K993736, #K010120). Modifications were made to the femoral stem cone design, neck geometry and through-hole diameter. The material composition, surface finish, neck angle, neck length and metaphyseal taper connection are unchanged.

The provided document is a 510(k) Summary of Safety and Effectiveness for orthopedic implants (Exactech® Alumina Femoral Heads and M-Series Neck Segments). It describes design changes to existing, legally marketed predicate devices.

This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of a typical medical device performance study (e.g., diagnostic accuracy, clinical endpoint achievement).

Instead, it focuses on demonstrating substantial equivalence to predicate devices through design considerations and laboratory-based engineering evaluations. The "conclusion" section states:

"Testing and engineering evaluations were conducted to verify that the performance of the new 12/14 alumina heads and the 12/14 neck segments would be adequate for anticipated in vivo loading. Based on successful results we conclude that the proposed devices are substantially equivalent Exactech's predicate devices."

This implies that the "acceptance criteria" were met if the new designs performed adequately in engineering tests simulating in vivo loading, demonstrating equivalence to the predicate devices. However, the specific quantitative acceptance criteria and detailed results of these tests are not provided in this summary.

Therefore, most of the requested information cannot be extracted from the provided text. Below, I will answer the questions based on the type of information presented in the document, highlighting what is missing.

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

Details not available in the document: Specific quantitative acceptance criteria (e.g., load limits, fatigue cycles) and the exact performance metrics achieved by the device in these "testing and engineering evaluations."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not specified. The document refers to "testing and engineering evaluations," which typically involve a limited number of physical samples for mechanical testing, not a "test set" of patient data.
• Data Provenance: Not applicable in the context of this type of submission. The "evaluations" would be laboratory-based rather than from patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. This is not a study requiring expert-established ground truth for a diagnostic or clinical outcome. The "ground truth" for mechanical performance would be established by engineering standards and validated testing protocols.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. No clinical test set or adjudication process is described.

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

• No, an MRMC comparative effectiveness study was not done. This submission is for orthopedic implants, not an AI or diagnostic imaging device.

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

• Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• The "ground truth" for this type of device (orthopedic implant) is typically established by engineering and mechanical standards, simulating biomechanical forces and wear. These evaluations were used to demonstrate that the device is "adequate for anticipated in vivo loading" and "substantially equivalent" to predicate devices.

8. The sample size for the training set

• Not applicable. There is no concept of a "training set" in this context.

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

• Not applicable.

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