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This device is indicated in knee arthroplasty in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primatic 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 patellectorny, moderate valgus, varus, or flexion contraction. This device is intended for use in patients who require augmentations due to inadequate bone stock and/or require increased stabilization for tibiofemoral joint due to soft tissue imbalance. The femoral and tibial augments are to be attached to their respective components with a fixation screw or screws. Note: In the US, this device is for cemented use only.

U2 Total Knee System - PSA Tibial Insert is an extended design of U2 Total Knee System - PSA Type (K082424) including XPE Tibal Insert, PSA and XPE Tibial Insert, PSA, LC. This System is a patellofemorotibial polymer / metal / polymer, semi-constrained, cemented knee prosthesis, which is intended for use in patients who require augmentation and/or stem extensions due to inadequate bone stock. U2 Total Knee System - PSA Tibial Inserts are available in a range of thicknesses and in two design configurations: PSA and PSA-LC type. For the PSA tibial insert, it is intended for use in patients who require constrained stabilization for tibiofemoral joint due to soft tissue imbalance. PSA-LC (low constrained) tibial insert provide less constrained stabilization than PSA tibial insert.

The provided FDA 510(k) summary (K161360) describes the U2 Total Knee System - PSA Tibial Insert. However, it does not provide information about acceptance criteria and a study proving device performance in the context of an AI/ML powered device. This document is for a traditional medical device (knee prosthesis) and its assessment is based on mechanical testing and comparison to predicate devices, not on AI/ML parameters.

Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth for an AI/ML powered device study is not applicable or not available in the provided text.

Here's a breakdown of what can be extracted and what cannot:

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

• Not applicable/Not available in the context of AI/ML performance. The document focuses on mechanical and material properties of a physical medical device. It states that "Range of Motion and Spine Fatigue Test were conducted to evaluate the safety and effectiveness of the subjected device." However, specific acceptance criteria and detailed quantitative results for these tests are not provided in this summary. It mentions that the design has the same curvature as a previously cleared device, implying that its performance in terms of constraint, contact area, and pressure should be identical.

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 information pertains to studies for AI/ML performance, not mechanical testing of a physical implant. The "test set" in this context would refer to the physical specimens used for mechanical testing, but their number and provenance are not detailed in this summary.

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. This is relevant for AI/ML studies. Ground truth for a physical device's mechanical testing is established by engineering standards and measurements, not expert human interpretation.

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

• Not applicable. This is relevant for AI/ML studies involving human reviewers.

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 type of study is for evaluating AI-assisted diagnostic or interpretation tools. This document describes a knee implant.

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

• Not applicable. This is for AI/ML algorithms.

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

• Not applicable in the AI/ML sense. For a physical device, "ground truth" for mechanical performance would be established through highly controlled, standardized laboratory measurements (e.g., ISO standards for knee implants). The summary states "Range of Motion and Spine Fatigue Test were conducted," implying such laboratory methods.

8. The sample size for the training set

• Not applicable. This is for AI/ML algorithms.

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

• Not applicable. This is for AI/ML algorithms.

In summary: The provided document is a 510(k) clearance letter and summary for a physical medical device (knee implant). It assesses the device's substantial equivalence to predicate devices based on design, materials, and mechanical performance tests, not on the performance of an AI/ML algorithm. Therefore, requests for AI/ML specific study parameters cannot be fulfilled from this text.

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