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The EVOLUTION® NitrX™ Medial-Pivot Knee 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 treatment of fractures that are unmanageable using other techniques.

The EVOLUTION® Medial-Pivot Total Knee System Nonporous implants are for cemented use only.

The EVOLUTION® NitrX™ Medial-Pivot Knee is a line extension of the EVOLUTION® MP Total Knee System product line. The device is intended to be used as a medial pivot option in total knee arthroplasty (TKA). The subject device is composed of a femoral component to replace the distal surface of the patient's natural femur and a tibial baseplate component to replace the proximal surface of the patient's natural tibia. The design features are summarized below:

• Manufactured from Cobalt Chrome Alloy
• Coated with Titanium Niobium Nitride
• Sizes 1-8, left and right

This document is a 510(k) Premarket Notification for the EVOLUTION® NitrX™ Medial-Pivot Knee. It focuses on demonstrating substantial equivalence to existing predicate devices rather than providing an independent study to prove the device meets acceptance criteria as would be done for a novel AI/software medical device.

Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes for test and training sets, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies is not applicable in this context.

Here's why and what information is available:

• Device Type: The EVOLUTION® NitrX™ Medial-Pivot Knee is a physical orthopedic implant (knee prosthesis), not an AI/software medical device. The "acceptance criteria" for such a device are typically met through demonstrating substantial equivalence to a legally marketed predicate device in terms of indications for use, technological characteristics, and safety and effectiveness information.
• Study Focus: The submission is a "Traditional 510(k)" which aims to show the new device is as safe and effective as an already cleared device. This is done through nonclinical testing (e.g., biocompatibility, mechanical testing) and comparison to predicate devices, rather than clinical efficacy studies against specific performance metrics for diagnostic or prognostic tasks.
• Clinical Testing: The document explicitly states: "Clinical data was not provided for the subject devices." This further confirms that a prospective clinical study with human readers and ground truth, as implicitly requested by your prompt's structure, was not conducted or submitted for this specific device clearance.

Available Information from the document, rephrased to fit the prompt's categories where possible but noting the lack of direct applicability:

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

   • Acceptance Criteria (Implicit for 510(k) clearance): Substantial equivalence to predicate device(s) regarding indications for use, technological characteristics, and safety and effectiveness.
   • Reported Device Performance:
     • Nonclinical Testing Performed on Subject Device: Biocompatibility evaluation/testing, Tibial baseplate component fatigue testing, Wear analysis (Mode 1 and aggressive Mode 3), Morphological analysis, Metal ion analysis.
     • Nonclinical Predicate Test Results Used to Support Subject Device: Range of motion analysis, Stability/Constraint, Contact area/stress, MR Assessments (Field Interactions, Torque, Displacement, RF Heating), Gravimetric Analysis, Bioburden Testing.
     • (Specific quantitative performance values for these tests are not provided in this summary document.)

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

   • Not applicable in the context of mechanical and material testing for an implant. The "samples" would be the manufactured device components subjected to various engineering tests. No test set of patient data is described.

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. Ground truth for an AI/software device involving human interpretation is not relevant for this orthopedic implant. The "ground truth" for mechanical testing would be established by industry standards, engineering principles, and validated test methods.

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

   • Not applicable. This is a concept used for human reader studies, not for mechanical device testing.

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 MRMC study was done (not applicable for this device type).

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

   • Not applicable. This is not an algorithm-based device.

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

   • For the nonclinical testing, the "ground truth" implicitly relies on established engineering principles, material science standards, and accepted testing methodologies (e.g., ISO standards for wear testing, biocompatibility standards).

8. The sample size for the training set:

   • Not applicable. There is no AI model or training set for this physical implant.

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

   • Not applicable. There is no AI model or training set for this physical implant.

In summary, this document is a regulatory submission for a physical medical device (a knee implant) cleared via the 510(k) pathway, which fundamentally differs from the type of device (e.g., AI/ML-based software) that would involve the specific "acceptance criteria" and "study" details requested in your prompt regarding human reader performance or algorithm-specific metrics.

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