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This device 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 intended for cemented use only.

This device is an additional size extension to the previously cleared "UNITED" U2 Total Knee System (K051640). The materials; design, safety and effectiveness of this subject is identical to the previously cleared femoral components - PS type of "UNITED" U2 Total Knee System (available in sizes #1~#6 ranging from 52mm/ 56mm AP-ML to 72mm/ 76mm A/P-M/L), except for its larger size (76mm/80mm A/P-M/L). This device machined from cast Co-Cr-Mo alloy conforming to ASTM F75 are available in left and right configurations. Fixation of the femoral component to the femur is achieved using bone cement. This device is intended to be used with the previously cleared U2 PS tibial insert (K051640), U2 XPE tibial inserts - PS type (K112463), U2 tibial baseplate (K051640), U2 Patella components (K051640, K082469) and U2 XPE Patella components (K112463) in anv size. The size extending of femoral component does not affect the intended use of the device or alter the fundamental scientific technology of the device.

The provided text describes a 510(k) summary for a medical device, the U2 Femoral Component, PS, #7, which is an additional size extension to an existing knee prosthesis.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state specific numerical acceptance criteria for performance metrics. Instead, it relies on the concept of "substantial equivalence" to predicate devices. The performance data presented are qualitative statements indicating that tests were completed and demonstrated safety and effectiveness.

The study that "proves the device meets the acceptance criteria" is described as the completion of these performance tests as "part of the design assurance process." The conclusion derived is that the device is "substantially equivalent to the predicate device."

Additional Requested Information:

Since this document is a 510(k) summary for a medical device (a knee prosthesis component), the requested information typically relates to AI/software performance studies. This document does not describe an AI or software-based device, but rather a physical implant. Therefore, many of the questions regarding AI-specific study details (such as sample size for test/training sets, experts for ground truth, MRMC studies) are not applicable in this context.

However, I will address what can be inferred from the provided text in relation to these points:

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

• Not applicable for AI/software. For the physical device, mechanical and material tests were performed. The "test set" would refer to the number of components tested for each performance metric (e.g., how many components underwent fatigue testing). This detail is not provided in the summary.
• Data provenance: The testing was part of the "design assurance process" presumably conducted by the manufacturer, United Orthopedic Corporation, based in Hsinchu, Taiwan.

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

• Not applicable for AI/software. For a physical implant, ground truth is established through engineering and biomechanical principles and standardized testing methods (e.g., ASTM F75 for Co-Cr-Mo alloy). Expert consensus in the traditional sense of clinical imaging interpretation is not relevant here.

4. Adjudication method for the test set:

• Not applicable for AI/software. For mechanical testing, adjudication would involve interpreting test results against engineering specifications or established standards, rather than clinical consensus.

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 device is a physical knee implant, not an AI or software diagnostic tool. No human reader study with or without AI assistance would be relevant for demonstrating its performance.

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

• Not applicable. This is a physical medical device.

7. The type of ground truth used:

• For mechanical and material properties, the ground truth is based on engineering standards, biomechanical principles, and performance characteristics established for predicate devices. For example, the Co-Cr-Mo alloy conforms to ASTM F75.

8. The sample size for the training set:

• Not applicable. This device is a physical knee implant, not an AI/ML algorithm requiring a training set.

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

• Not applicable. (See point 8)

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