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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 contraction. This device may also be indicated in the salvage or previously failed surgical attempts or for knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. This device system is designed for cemented use only.

The subjected device is designed for the replacement of the bearing and/or articulating surfaces of the proximal tibia composed of an articulating bearing surface fixed in a metal tibial baseplate, and is used for patients in primary or revision surgery who require augmentation and/or stem extensions due to inadequate bone stock. This premarket notification includes the following components: U2 Tibial Baseplate-CMA type, #7 Tibial Insert (CR/PS), #7 XPE Tibial Insert (CR/PS) and #7 Tibial Augment.

U2 Tibial Baseplate-CMA (Cemented Modular Augmentation) is manufactured from titanium alloy forging (ASTM F620) which is forged by titanium alloy bars (ASTM F136) with seven proportional sizes (#1 to #7). Tibial Insert and XPE insert, including PS type and CR type, is an additional size extension to the previously cleared "UNITED" U2 Total Knee System (K051640, K103733). It is manufactured from UHMWPE (ASTM F648/ISO 5834) with five available thicknesses (9, 11, 13, 15, and 18 mm). Tibial Augment is an additional size extension to the previously cleared "UNITED" U2 Total Knee System-PSA Type (K082424, K122183). It is manufactured from Ti-6Al-4V alloy (ASTM F136/ISO 5832-3) with three available thicknesses (5, 10, 15mm).

This is a medical device 510(k) summary for the U2 Tibial Baseplate- CMA type, Tibial Insert and Augment, a semi-constrained total knee prosthesis. The document focuses on establishing substantial equivalence to predicate devices based on design, materials, manufacturing, and performance testing, rather than reporting on a study with acceptance criteria and device performance in the context of an AI/software device. Therefore, much of the requested information regarding AI device evaluation is not applicable or cannot be extracted.

However, I can provide available information based on the document's content:

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

The document lists performance tests conducted, but it does not specify quantitative acceptance criteria or the numerical results from these tests. It only states that "the test results demonstrated that this device is safe and effective."

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

• Sample size: Not specified. The document refers to "tests" in general, but does not provide details on the number of units or conditions tested for each performance category.
• Data provenance: Not applicable in the context of patient data regarding device performance. The testing pertains to the physical device components and their mechanical properties.

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

This information is not applicable as the evaluation is for a physical medical device (knee prosthesis) through mechanical testing, not an AI/software device requiring expert-established ground truth from images or other patient data.

4. Adjudication method for the test set:

Not applicable. This concept is relevant for studies involving human interpretation or clinical outcomes, not for the mechanical testing of a knee prosthesis.

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 AI/software device.

7. The type of ground truth used:

Not applicable in the context of clinical "ground truth" for an AI device. For this physical medical device, the "ground truth" for the tests would be established engineering standards, material specifications (e.g., ASTM, ISO standards), and performance benchmarks for similar predicate devices.

8. The sample size for the training set:

Not applicable. This is not an AI/software device that requires a training set.

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

Not applicable. This is not an AI/software device that requires a training set.

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