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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 LPB 12/14 Femoral Stems are intended to be used in press-fit and cemented applications.

The Exactech M-Series LPB 12/14 Femoral Stem is a modular four-piece system consisting of a proximal neck segment, metaphyseal segment, diaphyseal segment and metaphyseal assembly screw. All of the components are interchangeable, therefore allowing for many sizing combinations to meet varying anatomical situations. The neck segments are machined from titanium alloy bar stock or forgings (ASTM F-1472), the metaphyseal segments are machined from titanium alloy forgings (ASTM F-1472), and the distal segments are machined from titanium alloy bar stock (ASTM F-1472). The metaphyseal screws are machined from titanium alloy (ASTM F 136). The LPB system is a modification to the Exactech M-Series 12/14 Femoral Stem system cleared through premarket notifications #K993736, #K011081 and #K032964. Changes to the device relative to the predicates include minor geometry modifications, raw material manufacturing changes and application of a low-plasticity burnishing (LPB) process to the distal taper of the neck segments.

The provided text describes a Special 510(k) Summary of Safety and Effectiveness for the Exactech® AcuMatch M-Series LPB 12/14 Femoral Stems. This type of submission is used when a device is significantly equivalent to a previously cleared device (predicate device) and involves minor modifications.

Crucially, this document does not contain an independent clinical study with acceptance criteria and reported device performance metrics in the way one would typically describe for a new diagnostic AI device. Instead, the document focuses on demonstrating substantial equivalence to predicate devices based on design modifications and associated verification activities.

Therefore, many of the requested sections (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set information) are not applicable or not present in this type of regulatory submission.

Here's an attempt to address the request based on the available information:

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

This document does not present quantitative acceptance criteria or performance metrics in the form of a table. The "acceptance criteria" for this Special 510(k) are met by demonstrating that the modified device, through risk assessment of design changes and successful completion of associated verification activities, remains substantially equivalent to the predicate devices. The "reported device performance" is implicitly that the device performs equivalently to the predicate devices.

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

Not applicable. This document describes mechanical/material modifications to an existing device, not a study involving a "test set" of patient data.

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

Not applicable.

4. Adjudication method for the test set

Not applicable.

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 is not an AI device or a diagnostic device where MRMC studies would be conducted.

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

Not applicable. This is not an AI algorithm.

7. The type of ground truth used

Not applicable in the typical sense of a diagnostic study. The "ground truth" here relates to engineering and material science principles, ensuring the modified materials and geometry meet established safety and performance standards for orthopedic implants.

8. The sample size for the training set

Not applicable.

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

Not applicable.

Summary of what the document does provide regarding "acceptance criteria" and "study":

The "study" in this context is the risk assessment of design changes and associated verification activities. The "acceptance criteria" are implied by demonstrating that these activities confirm the device's continued substantial equivalence to the predicate devices.

• Device Changes: The changes to the device (relative to predicates K993736, K011081, K032964) include:
  • Minor geometry modifications.
  • Raw material manufacturing changes.
  • Application of a low-plasticity burnishing (LPB) process to the distal taper of the neck segments.
• Verification Activities: The document states that the conclusion of substantial equivalence is "Based on a risk assessment of the design changes and successful completion of the associated verification activities". While the details of these verification activities are not provided in this summary, they would typically involve:
  • Mechanical testing (e.g., fatigue, static strength, wear) to ensure the modified components meet or exceed the performance of the predicate device.
  • Biocompatibility testing (if new materials or significant processing changes affecting biocompatibility were introduced).
  • Material characterization (e.g., to confirm the properties of the raw materials and the effect of the LPB process).
• Conclusion: The regulatory acceptance, indicated by the FDA's 510(k) clearance letter (K051858), signifies that the FDA agreed with Exactech's conclusion of substantial equivalence to legally marketed predicate devices, meaning the device's safety and effectiveness were demonstrated through engineering verification, not a clinical trial with patient outcome data.

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