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The Evolution® Total Knee Systems can be implanted using the Kinematic Alignment technique. When the Kinematic Alignment approach is utilized, the devices are indicated for 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;

The Evolution® Kinematic Alignment technique may only be used with Evolution® Primary Knee components or the Evolution® Stemmed CS Femur and Evolution® Revision Tibia Base.

The purpose of this submission is to seek clearance for the Evolution® Total Knematic Alignment Instrumentation and Technique. The instruments consist of resection and alignment guides, calipers, spacers, and trays that are used in conjunction with MicroPort's existing 510(k)-cleared knee instrumentation. The Kinematic Alignment technique is to duplicate the pre-arthritic native joint line. Unlike Mechanical Alignment where the focus is placed on making a perpendicular tibial resection, non-anatomic distal and posterior femoral cuts, and ligament releases if needed, Kinematic Alignment prioritizes the femoral cuts to replicate the native joint line. The Kinematic Alignment technique compensates for wear on the prearthritic joint line and strives for natural ligament tension.

The Evolution® Kinematic Alignment surgical technique is used with the following 510(k)-cleared knee components. No changes to the compatible Evolution® implants are being presented in this 510(k). The compatible implants are axactly the same as the previously cleared Evolution® implants.

• · Evolution® MP Total Knee System, K093552
• · Evolution® MP Total Knee System, K102380
• · Evolution® MP CS/CR Porous Femur, K140735
• · Evolution® Biofoam® Tibial Base and Evolution Biofoam Modular Keels, K152298
• · Evolution® Revision Tibia Base System, K162026
• · Evolution® Biofoam Tibial Base with Biofoam® Additive Manufacturing, K170288
• · Evolution® Stemmed CS Femur, K182125
• Evolution® NitrX™ Medial-Pivot Knee, K182251

The provided text is a 510(k) summary for the MicroPort Orthopedics Inc. "Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and Technique." It outlines the regulatory clearance process for a new surgical technique and associated instrumentation, not an AI/ML-based medical device. Therefore, the information requested in your prompt regarding acceptance criteria, study design for AI performance, sample sizes for test and training sets, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and ground truth types is not applicable to this document.

This document describes a medical device (surgical instrumentation for knee replacement) that falls under traditional medical device regulations, where clearance is typically based on demonstrating substantial equivalence to pre-existing, legally marketed predicate devices through non-clinical testing and comparison of technological characteristics. There is no mention of software with AI/ML components requiring performance evaluation against specific metrics like sensitivity, specificity, or accuracy, nor is there any data related to how human readers improve with AI assistance.

The document explicitly states: "Not applicable. Clinical data were not necessary for the subject device." and "The nonclinical analyses and validations demonstrate that the device is as safe and effective and performs as well or better than the legally marketed predicate and reference devices." This confirms that the clearance was based on non-clinical engineering and design validation, not clinical performance studies involving outcome data or expert consensus for AI/ML performance.

Therefore, I cannot provide the requested information based on the provided text. The prompt's questions are tailored for AI/ML medical devices, which this document does not describe.

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The EVOLUTION® Cement Keel 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® Cement Keels are for cemented use only.

MicroPort Orthopedics Inc. is seeking clearance to introduce the subject device, the EVOLUTION® Cement Keel, a line extension to the predicate EVOLUTION® Revision Tibial System cleared in K162026. It is a smaller, lower-profile size compared to the existing predicate Modular Keels, is manufactured from Ti6Al4V alloy conforming to ASTM F136, and is compatible with the same tapers as the predicate. The intended use of the subject modular keel is identical to the predicate, which is to provide optional rotational stability and added fixation to the compatible tibial bases.

The provided text is a U.S. FDA 510(k) summary for a medical device called the "EVOLUTION® Cement Keel." This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving the device meets specific performance acceptance criteria through the kind of study typically associated with AI/software devices.

Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set information) are not applicable (N/A) because this submission is for a physical orthopedic implant seeking equivalence based on design, materials, and non-clinical testing, not a de novo or AI/ML-based device that requires extensive clinical validation against specific performance metrics using human experts and large datasets.

Here's the breakdown of the information provided in the context of your questions:

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

• Acceptance Criteria: The core "acceptance criteria" for this 510(k) submission is demonstrating substantial equivalence to the predicate device (EVOLUTION® Revision Tibial System, K162026) regarding indicators for use, technological characteristics, and safety/effectiveness. There are no quantitative performance metrics for the device itself listed as acceptance criteria in the way you might see for a diagnostic AI.
• Reported Device Performance: The "performance" is demonstrated through:
  • Dimensional comparison analysis: The subject device is a smaller, lower-profile size compared to the predicate modular keels.
  • Leveraging predicate test data: Axial and rotational distraction testing data from the predicate (K162026) were leveraged due to dimensional equivalency.
  • Material equivalency: Manufactured from Ti6Al4V alloy conforming to ASTM F136, which is equivalent to the predicate.
  • MRI safety evaluation: Per various ASTM standards and FDA guidances (ASTM F2182-19, F2182-11a, F2181-11, F2052-15, F2213-17, F2119-07, and FDA guidances on MR environment safety).
  • Biocompatibility, sterility, and shelf life: Justified based on equivalency to the predicate, as the subject implant materials are identical, and overall geometry/site of application are the same.

Table (Conceptual - as actual metrics are not provided in this type of submission):

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 applicable. This submission relies on non-clinical testing (dimensional analysis) and leveraging previous test data from the predicate device, not a distinct "test set" of patient data or a clinical study for the new device.
• Data Provenance: Not applicable for a new clinical data set. The data leveraged is from non-clinical mechanical testing and material evaluations of previous iterations or the predicate device.

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 as understood in the context of AI/ML or diagnostic device validation (e.g., expert consensus on medical images) is not relevant for this type of implant submission, which relies on engineering and materials science principles, and equivalency to previously cleared devices.

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

• Not applicable. There is no clinical "test set" requiring adjudication of findings.

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. An MRMC study is relevant for AI-assisted diagnostic tools, not for a knee implant.

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

• Not applicable. This is a physical orthopedic implant, not an algorithm.

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

• Not applicable in the context of clinical ground truth for diagnostic purposes. The "ground truth" for this device's acceptance is its compliance with engineering standards, material specifications, and its demonstrated substantial equivalence through non-clinical testing and comparison to the predicate device.

8. The sample size for the training set

• Not applicable. No training set is involved as this is not an AI/ML or data-driven device.

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

• Not applicable.

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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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MicroPort knee instruments are accessory devices and are intended to be used to assist in the implantation of MicroPort Total Knee Systems in their cleared Indications for Use as provided below:

MicroPort Total Knee Systems are 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.

Non-porous MicroPort total knee replacement implants are for cemented use only.

Porous coated MicroPort total knee replacement implants, including ADVANCE® BIOFOAM® Tibial System and EVOLUTION® BIOFOAM® Tibial System implants, are for use without bone cement.

MicroPort's PROPHECY® Pre-Operative Navigation Alignment Guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of total knee replacement components intra-operatively and in quiding the marking of bone before cutting. The PROPHECY® Pre-Operative Navigation Alignment Guides are intended for use with MicroPort's ADVANCE® and EVOLUTION® Total Knee Systems and their cleared indications for use, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans. The PROPHECY® Pre-Operative Navigation Alignment Guides are intended for single use only.

The device modification consists of an alteration to the sterilization instructions for FDAcleared MicroPort Orthopedics' (MPO) non-sterile knee orthopedic joint replacement instruments. The subject instruments are part of MicroPort Orthopedics' 510(k)-cleared knee product lines and are required to facilitate total knee arthroplasty procedures. The modification will allow the option to sterilize the subject instruments using an FDA-cleared containment device. The subject devices will be placed in an FDA-cleared containment device, which will be double-wrapped in an FDA-cleared CSR wrap or similar type nonwoven, medical grade wrapping material, and then steam sterilized.

The modified sterilization process of the subject instruments was successfully challenged and validated through worst-case load configurations using an FDA-cleared containment device. The intended use and sterilization parameters, such as cycle, temperature, and exposure time, remain identical to the predicate devices.

Here's a breakdown of the requested information based on the provided document:

Acceptance Criteria and Device Performance Study for MPO Knee Instruments Reprocessing Change (K213817)

This submission (K213817) focuses on a modification to the sterilization instructions for existing, FDA-cleared MicroPort Orthopedics' non-sterile knee instruments. The device itself (the instruments) remains unchanged in its design or intended use. The study specifically validates the modified sterilization process.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this submission is for a sterilization process change rather than a new diagnostic or AI-driven device, the acceptance criteria are related to the effectiveness of the sterilization and the integrity of the instruments after the new process.

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

The document does not explicitly state a numerical "sample size" in terms of how many individual instruments were tested or how many sterilization cycles were run. However, the testing was conducted under "worst-case load configurations," implying a robust validation approach.

• Sample Size: Not explicitly stated as a numerical count of individual instruments or cycles. Testing was performed under "worst-case load configurations" and for "MicroPort orthopedic joint replacement instruments."
• Data Provenance: The studies were non-clinical validation tests performed by MicroPort Orthopedics Inc. There is no mention of country of origin for data or whether it was retrospective or prospective, as it pertains to laboratory validation of a manufacturing process change.

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

This section is not applicable to this submission. The device is a set of surgical instruments, and the study is a non-clinical validation of a sterilization process. There is no "ground truth" to be established by human experts in the way that would apply to diagnostic imaging or AI devices. The conformity to sterilization standards (AAMI ST77:2013 and AAMI ST79:2017) and vibration testing (ISTA 2A) serves as the "ground truth" for the performance of the modified process.

4. Adjudication Method for the Test Set

This section is not applicable. Since there are no human experts establishing a ground truth for a diagnostic outcome, there is no adjudication method. The test results are objective measurements against established engineering and sterilization standards.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No. A MRMC comparative effectiveness study is designed for evaluating human performance, often with and without AI assistance, typically in diagnostic tasks. This submission is for surgical instruments and a sterilization process change, so such a study is not relevant or required.

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

No. This question typically applies to AI algorithms. The device being discussed is physical surgical instrumentation, and the study is evaluating a sterilization process, not an algorithm's performance.

7. The Type of Ground Truth Used

The "ground truth" for this submission is established by adherence to recognized industry standards and validated testing protocols for sterilization and material integrity:

• Sterility: Demonstrated by successful validation according to AAMI ST77:2013 and AAMI ST79:2017, likely involving biological indicator testing and sterility assurance level (SAL).
• Physical Integrity/Durability: Demonstrated by successful vibration testing according to ISTA 2A.

8. The Sample Size for the Training Set

This section is not applicable. There is no "training set" in the context of validating a sterilization process for physical surgical instruments. Training sets are relevant for machine learning algorithms.

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

This section is not applicable, as there is no training set for this type of submission.

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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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