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The EVOLUTION® Hinge 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® Hinge Knee System implants are for cemented use only.

The EVOLUTION® Hinge Knee System is a hinged, constrained cemented total knee system being introduced as a line extension to MicroPort Orthopedics Inc.'s EVOLUTION® Revision knee portfolio. The system is composed of:

• a femoral component offered in 7 sizes (sizes 2-8) with femoral yoke fixation screw for ● attachment to the yoke assembly
• a hinge yoke assembly offered in 9 sizes based on femur size (size 2-3, 4-6, and 7-8) and tibial insert thickness (small, medium, large)
• a yoke extension stop offered in 3 options (0°, 5°, 10°)
• a tibial insert offered in 8 sizes (sizes 1-8) and in 5 thickness options (12, 14, 17, 20, 24mm)
• a tibial base offered in two variants:
  • modular (8 sizes, 1-8) with tibia locking screw for attachment to stem extensions o and stem extension adapters
  • monolithic (3 sizes, 1-3) with fixed small keel o
• . Offset adapters (2 sizes, 4mm x 25mm and 8mm x 25mm) and valgus stem adapters (2 sizes, 1° x 25mm and 2° x 25mm)
• Universal femoral augments
  • distal augments offered in 7 sizes (sizes B-H) in 4, 8, 12, 16, and 20mm o thicknesses
  • posterior femoral augments in 7 sizes (sizes B-H) in 4, 8, and 12mm thicknesses, O
• Medial and lateral tibial augments offered in 8 sizes (sizes 1-8) in 5, 10, and 15mm thicknesses

Components are manufactured from cobalt chrome alloy, titanium alloy, UHMWPE and crosslinked UHMWPE, and PEEK conforming to ASTM F75, F1537 - Alloy 1, F136, F648, F2026, respectively.

The system includes new and existing instrumentation from K140735, K162026, and K171389 to facilitate device implantation.

The subject femoral offset adapters and femoral valgus adapters are not for use with the EVOLUTION® Hinge tibial bases. The subject system is compatible with previously cleared stem extensions, stem extension adapters, and modular keels cleared in K162026 and patellae from K953439 and K122218. Furthermore, the subject universal femoral augments introduced in this 510(k) are backwards compatible with the EVOLUTION® Femurs cleared in K142550, K171389, and K182125.

I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets acceptance criteria. The document is an FDA 510(k) premarket notification for a knee system, primarily discussing its substantial equivalence to previously marketed devices based on non-clinical testing, design features, and materials.

It explicitly states:

• "Clinical data were not provided for the subject device." (Page 7, Section E. Clinical Testing)

Therefore, I cannot provide the requested information, which includes:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used and their qualifications for ground truth.
4. Adjudication method for the test set.
5. Results of a multi-reader multi-case (MRMC) comparative effectiveness study.
6. Results of a standalone (algorithm only) performance study.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document focuses on mechanical and material testing, and substantial equivalence, not a clinical study involving an AI or diagnostic device with acceptance criteria for performance metrics like sensitivity or specificity.

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The EVOLUTION® Revision CCK 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 treatment of fractures that are unmanageable using other techniques.
   The EVOLUTION® Medial-Pivot Total Knee System Nonporous implants are for cemented use only.

EVOLUTION® Revision CCK (Constrained Condylar Knee) is being introduced to supplement MicroPort Orthopedics' knee product lines to provide options in the case of revision or complex primary total knee replacements. The design features are summarized below:

• Components manufactured from cobalt chrome alloy, titanium alloy, and UHMWPE conforming to ASTM F75, F136, and F648, respectively
• . Available in 8 standard sizes, left and right
• Available in 2 plus sizes, left and right
• . System includes femoral component, augments, stem offset adapters, tibial insert and stem cap

The provided text describes the MicroPort Orthopedics EVOLUTION® Revision CCK System, a knee joint prosthesis. However, it does not contain a study that establishes acceptance criteria and then proves the device meets those criteria in the typical format of a diagnostic or AI/software device.

Instead, this 510(k) summary focuses on demonstrating "substantial equivalence" to predicate devices based on design features, materials, and non-clinical performance testing. The information provided is primarily related to mechanical and material performance rather than diagnostic accuracy or human performance with or without AI.

Therefore, I cannot fulfill all parts of your request as posed because the document is not an "acceptance criteria study" in the sense you are asking for. It is a regulatory submission demonstrating substantial equivalence.

Based on the provided text, I can extract information relevant to non-clinical performance testing:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" for each test in a pass/fail format alongside numerical performance values. Instead, it describes comparative performance against a predicate device. The general "acceptance criteria" can be inferred as performing "as well as" or "greater than" the predicate device for various mechanical properties to demonstrate substantial equivalence.

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The EVOLUTION® Revision Tibial 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 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® Revision Tibial System is being introduced to supplement MicroPort Orthopedics' knee product lines to provide revision surgery options with a cemented tibial base. The design features are summarized below:

• Manufactured from titanium alloy conforming to ASTM F620/F136 (forged/wrought) .
• Available in 8 standard sizes, left and right ●
• . Available in 3 plus sizes, left and right
• Tibial base has holes for augment attachment screws
• System includes tibial base, modular keels, block augments, stem adapters (offset & extension), stem extensions (cemented & canal-filling cementless) and stem caps (metallic and poly)

The provided text is a 510(k) Summary for a medical device called the "EVOLUTION® Revision Tibial System." This document is a regulatory submission to the FDA and primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a study proving device performance in the way one might expect for a novel AI/software medical device.

Therefore, many of the requested elements (e.g., sample size for test set, number of experts for ground truth, MRMC study, sample size for training set, how training set ground truth was established) are not applicable or provided in this document as it pertains to a mechanical orthopedic implant, not an AI/software device that would involve such testing.

Here's a breakdown of the available information:

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

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

This information is not provided. The testing described is non-clinical (laboratory/mechanical testing of the implant itself) and does not involve human sample sizes or data provenance in the context of clinical trials or AI model evaluation.

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. The ground truth for mechanical device performance is established by engineering standards (e.g., ASTM F1800, ASTM F2009) and the physical properties of the materials and design, not by expert human interpretation in a medical imaging context.

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

Not applicable. Adjudication methods are relevant for human-interpreted medical data, 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

Not applicable. This is not an AI-assisted device.

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

Not applicable. This is not an algorithm-only device.

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

The "ground truth" for the non-clinical testing is based on established engineering standards and specifications (e.g., ASTM standards for fatigue and static evaluation), and the physical test results compared against those standards or the predicate device's established performance.

8. The sample size for the training set

Not applicable. This is a physical orthopedic implant, not a software/AI device that requires a training set.

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

Not applicable. There is no training set for this type of device.

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