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The EVOLUTION™ MP Total Knee System is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:

1. noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
2. inflammatory degenerative joint disease including rheumatoid arthritis;
3. correction of functional deformity;
4. revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.
   The EVOLUTION™ Total Knee System is for cemented use only.

The subject of this Special 510(k)-Premarket Notification is to request a performance specification modification to increase the functional range of motion for the Wright Medical Technology, Inc. EVOLUTION™ MP Total Knee System. The EVOLUTION™ MP Total Knee System consists of existing total knee implant devices. No new total knee components are being introduced as a result of this Special 510(k) premarket notification.
The EVOLUTION™ MP Total Knee System was evaluated via mechanical testing and engineering analyses; including static stability and contact area testing. A review of these results indicates that the EVOLUTION™ MP Total Knee System is equivalent to predicate devices and are capable of withstanding expected in vivo loading without failure.

The provided text is for a 510(k) premarket notification for a knee system, and it does not contain any information about acceptance criteria or a study proving device performance against such criteria for an AI/ML device.

The document states that the "EVOLUTION™ MP Total Knee System was evaluated via mechanical testing and engineering analyses; including static stability and contact area testing." However, this refers to the physical knee system, not an AI/ML device.

Therefore, I cannot provide the requested information for an AI/ML device based on the given text.

If you have a document related to an AI/ML device with acceptance criteria and performance study details, please provide that.

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The EVOLUTION™ MP Total Knee System is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:

1. non-inflammatory degenerative joint disease: including osteoarthritis, traumatic arthritis, or avascular necrosis;
2. inflammatory degenerative joint disease including rheumatoid arthritis;
3. correction of functional deformity;
4. revision procedures where other treatments or devices have failed; and
5. treatment of fractures that are unmanageable using other techniques.
   The EVOLUTION™ MP Total Knee System is for cemented use only.

The design features of the EVOLUTION™ MP Total Knee System are summarized below:

• Femoral components manufactured from Cobalt Chrome Alloy
• Femoral component sizes 1 8, left and right
• Intended to be used with currently available patella components
• Tibial inserts manufactured from UHMWPE
• Tibial insert sizes 1 8, left and right
• Tibial insert thickness: 10, 12, 14, 17, 20, 24mm
• Tibial bases manufactured from Cobalt Chrome Alloy
• Tibial base sizes 1 8, left and right
• Asymmetric

This document is a 510(k) summary for a medical device called the "EVOLUTION™ MP Total Knee System". It describes the device's intended use, features, and its substantial equivalence to previously cleared predicate devices.

Here's an analysis of the provided text in relation to your request:

1. Table of acceptance criteria and reported device performance:

Based on the provided text, there are no explicit acceptance criteria or reported device performance metrics in the typical sense (e.g., accuracy, sensitivity, specificity, or specific mechanical test results with defined pass/fail thresholds). This document is a 510(k) summary, which primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance study results against specific criteria.

The core of the submission revolves around the assertion that:

• "The indications for use of the EVOLUTION™ MP Total Knee System are identical to the previously cleared predicate devices."
• "The design features and materials of the subject devices are substantially equivalent to those of the predicate devices."
• "The fundamental scientific technology of the modified devices has not changed relative to the predicate devices."
• "The safety and effectiveness of the EVOLUTION™ MP Total Knee System are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification."

Therefore, instead of a table of acceptance criteria, the "acceptance" granted by the FDA is a determination of substantial equivalence to existing predicate devices. The "reported device performance" is implicitly considered to be equivalent to that of the predicate devices.

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

The provided document does not describe a specific clinical or performance test set with a sample size. The substantial equivalence claim is based on comparing the device's design, materials, and intended use to predicate devices, which likely involved a review of existing data and specifications rather than new testing on a specific "test set" of patients or samples. The document does not mention data provenance (country of origin, retrospective/prospective).

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

This information is not applicable as the document does not describe a performance study with a test set requiring expert ground truth establishment.

4. Adjudication method for the test set:

This information is not applicable as the document does not describe a performance study with a test set requiring adjudication.

5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and its effect size:

This information is not applicable. The device is a total knee system (an implant), not typically subjected to MRMC studies (which are common for diagnostic imaging AI). The submission focuses on device design and material equivalence.

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

This information is not applicable. This device is a physical knee implant, not an algorithm.

7. The type of ground truth used:

This information is not applicable as the document does not describe a performance study relevant to establishing ground truth for a diagnostic or AI device.

8. The sample size for the training set:

This information is not applicable. The device is a physical knee implant; thus, there is no "training set" in the context of machine learning or AI.

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

This information is not applicable for the same reason as point 8.

In summary, the provided document is a 510(k) summary for a total knee system seeking market clearance based on substantial equivalence to predicate devices, not through a conventional performance study with explicit acceptance criteria, test sets, or efficacy data in the typical sense of AI/diagnostic device submissions.

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