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The U2 Total Knee system is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion deformities. This device may also be indicated in the salvage of previously failed surgical attempts if the knee can be satisfactorily balanced and stabilized at the time of surgery. This device is a single use implant and intended for cementless use only.

U2 Femoral Component, CR, Porous Coated, Additional Sizes is an extension of cleared "UNITED" U2 Femoral Component, CR, Porous Coated (K140075). The indications, major design features, materials, major manufacture processing and methods of this subject are identical to the cleared U2 Femoral Component, CR, Porous Coated (K140075). The cleared femoral components are available in size #1, #2, #3, #7, and the subjected femoral components are the intermediate sizes for #1.5, #2.5, #4.5, #5.5 and #6.5.

The provided text is related to a 510(k) premarket notification for a medical device: "U2 Femoral Component, CR, Porous Coated, Additional Sizes." This device is a knee joint prosthesis.

Based on the nature of this document (a 510(k) summary for a Class II knee prosthesis) and the content, this is not a document that describes an AI/ML medical device, nor does it detail a clinical study with diagnostic performance metrics (e.g., sensitivity, specificity, AUC) for such a device.

Instead, this document focuses on demonstrating substantial equivalence to a previously cleared predicate device (K140075) for additional sizes of a physical implant. The "performance data" mentioned refers to mechanical properties and engineering analysis, not diagnostic accuracy studies.

Therefore, most of the questions about acceptance criteria for AI/ML performance, sample sizes for test/training sets, expert adjudication, MRMC studies, and ground truth types are not applicable to this document.

However, I can extract the relevant information from the provided text regarding the device and its compliance:

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

The document does not provide a table of precise acceptance criteria in terms of numerical thresholds for diagnostic performance (as would be typical for an AI/ML device). Instead, it states that the device was evaluated to conform to FDA guidance for mechanical properties.

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. This is not an AI/ML diagnostic device, so there's no "test set" in that context. The "performance data" refers to mechanical testing/analysis of physical implants, not data samples.

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. There is no ground truth, expert consensus, or clinical diagnostic evaluation described for this physical implant.

4. Adjudication method (e.g. 2+1, 3+1, none) 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.

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

Not applicable.

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

Not applicable. The "ground truth" here would essentially be established engineering principles and mechanical testing standards.

8. The sample size for the training set

Not applicable.

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

Not applicable.

Summary based on the provided document:

• Device Type: Physical medical implant (U2 Femoral Component, CR, Porous Coated, Additional Sizes) - a knee joint prosthesis.
• Purpose of Submission: To add intermediate sizes to an already cleared femoral component (K140075), demonstrating substantial equivalence.
• Performance Evaluation: Focused on mechanical properties testing and analysis to ensure the additional sizes do not negatively affect safety and effectiveness. This evaluation was conducted to conform to the "Class II Special Controls Guidance Document: Knee Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses."
• Methodology: Engineering analysis and mechanical testing, not clinical trials or diagnostic performance studies involving patient data or expert reads.

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The U2 Total Knee system is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion deformities. This device may also be indicated in the salvage of previously failed surgical attempts if the knee cannot be satisfactorily balanced and stabilized at the time of surgery.

For cemented femoral components, patellar components, tibial baseplate components and tibial inserts components: This device is a single use implant and intended for cemented use only.

For porous coated femoral component: This device is a single use implant and intended for cementless use only.

U2 Porous Coated Femoral Component-CR Type is manufactured from Co-Cr-Mo alloy confirming to ASTM F75. The inner surface is porous coated with Co-Cr-Mo beads (ASTM F75) to provide a porous surface for enhanced fixation. It is available in seven proportional sizes (#1~ #7, AP/ML ranging from 52mm to 76mm/ 80mm) and is provided in left and right configurations. The femoral component is the same as that of cleared U2 Total Knee System (K051640), except adding size #7.

The provided text describes a 510(k) submission for a medical device, the "U2 Femoral Component, CR, Porous Coated." This is a premarket notification to demonstrate that the device is substantially equivalent to a predicate device, and it primarily focuses on non-clinical performance data.

Therefore, the requested information regarding acceptance criteria, study details for AI performance, sample sizes for test/training sets, expert qualifications, ground truth establishment methods, and MRMC studies is not applicable or not provided in this type of submission. These details are typically associated with studies evaluating the performance of AI/CADe devices, which this document is not.

The device in question is a physical orthopedic implant, not a software or AI-based diagnostic tool. The performance data presented refers to mechanical and design-based tests.

Here's a breakdown of why each point of your request cannot be fully answered based on the provided document:

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

• Acceptance Criteria: Not explicitly stated as pass/fail thresholds against specific numerical values. The document states that "Tests as follows were conducted to evaluate the safety and effectiveness of the subjected device, and the test results demonstrated that this device is safe and effective." This implies all tests met their inherent safety and effectiveness requirements, but specific performance metrics and their acceptance benchmarks are not detailed.
• Reported Device Performance: The document lists the types of non-clinical tests performed, but does not provide the results or specific performance metrics from these tests. It only states that the tests "demonstrated that this device is safe and effective."

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

• Sample Size: Not applicable. The tests performed are non-clinical (e.g., mechanical tests on the implant itself), not involving human or clinical data.
• Data Provenance: Not applicable.

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

• Number of experts and qualifications: Not applicable. There is no "ground truth" to be established by experts as this is not a diagnostic device involving interpretation of data.

4. Adjudication method for the test set

• Adjudication method: 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

• MRMC study: No, this device is an orthopedic implant, not an AI or diagnostic tool. Thus, no MRMC study was performed.

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

• Standalone performance: No, this is not an algorithm or AI device.

7. The type of ground truth used

• Type of ground truth: Not applicable. For devices like this, safety and effectiveness are confirmed through established engineering and materials testing standards (e.g., ASTM F75 for Co-Cr-Mo alloy).

8. The sample size for the training set

• Training set sample size: Not applicable. This is not an AI/machine learning device that requires a training set.

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

• Ground truth establishment for training set: Not applicable.

Summary of Relevant Information from the Document:

• Device Type: U2 Femoral Component, CR, Porous Coated - a femoral component for total knee replacement, made from Co-Cr-Mo alloy and porous coated.
• Purpose of Submission: Demonstrate substantial equivalence to predicate devices (K051640 and K030612) by showing similar materials, design, manufacturing, and intended use, and adding a new size (#7).
• Performance Data: Non-clinical tests were conducted according to the "Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA."
• Specific Tests Performed (Non-clinical):
  • Range of Motion
  • Contact Area and Contact Pressure on Femorotibial Joint
  • Contact Area and Contact Pressure on Femoropatellar Joint
  • Subluxation of Femorotibial Joint
  • Fatigue Compression Test of Femoral Component
• Clinical Performance Data: "None provided as a basis for substantial equivalence." This further confirms that no studies involving human subjects or clinical outcomes were part of this specific 510(k) submission.

This 510(k) focuses on mechanical and physical properties of an implant, rather than the diagnostic accuracy or performance of a digital health or AI-driven device.

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