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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 system is designed for cemented use only.

U2 XPE Total Knee System includes U2 XPE tibial inserts and U2 XPE patellar components of a Total Knee System.

U2 XPE tibial inserts are intended to be used with the cemented U2 femoral components (K051640) and the cemented U2 tibial tray (K051640) in total knee arthroplasty. U2 XPE tibial inserts will be made in Cruciate Retaining (CR) and Posteriorly Stabilized (PS) designs.

If replacement of the articular surface of the patella is required, U2 XPE patellar components are intended to be used with any one of the "UNITED" femoral components (K021657, K051640, K082424) in total knee arthroplasty. U2 XPE patellar components are available in Onset with three pegs and Inset with one peg designs. The all polyethylene patellar components are intended for implantation with bone cement only.

The geometric design and size distribution of U2 XPE tibial inserts are identical to the previously cleared tibial inserts of U2 Total Knee System (K051640). The geometric design and size distribution of U2 XPE Onset patellar components and Inset patellar components are identical to the previously cleared U2 patellar components (K051640) and UKNEE patellar components (K021657) respectively. U2 XPE tibial inserts and patellar components are manufactured from irradiated UHMWPE which conform to ASTM F2565, while the UHMWPE raw material is in accordance with ASTM F648 and ISO 5834. The manufacturing processes are identical to the predicate devices tibial inserts and patellar components (K051640, K021657), except for the addition of irradiating the polyethylene and melt annealing steps to reduce free radicals of material. The irradiated UHMWPE material has been assessed according to the tests recommended in ASTM F2759.

The provided text describes the U2 XPE Total Knee System, a medical device. However, it does not contain specific acceptance criteria (numerical thresholds for performance) or detailed study results that demonstrate the device meets such criteria. Instead, it states that "Testing and analysis includes locking strength, range of motion and constraint, fatigue strength, wear simulation test, and materials properties of the U2 XPE Total Knee System, have been completed as part of the design assurance process demonstrated that this device is safe and effective and is substantially equivalent to the predicate device." This indicates that tests were performed, but the acceptance criteria met and the detailed results are not provided in this summary.

Therefore, for aspects like "Table of acceptance criteria and the reported device performance," "Sample size used for the test set," "Number of experts used to establish ground truth," and "Adjudication method," the information is not available in the provided document.

Here's what can be extracted based on the provided text:

1. Table of acceptance criteria and the reported device performance:

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

• Sample Size for Test Set: Not specified.
• Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It describes laboratory testing ("wear simulation test," "fatigue strength," etc.), rather than clinical trials with human subjects.

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

• Number of Experts: Not applicable, as this refers to laboratory-based performance testing, not human-adjudicated clinical data.
• Qualifications of Experts: Not applicable.

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

• Not applicable, as this refers to laboratory-based performance testing, not human-adjudicated clinical data.

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:

• No, an MRMC comparative effectiveness study was not done. This device is a total knee system, not an AI-assisted diagnostic tool for human readers.

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

• Not applicable. This device is a total knee system, not an algorithm.

7. The type of ground truth used:

• The "ground truth" for the performance testing of this device would be defined by engineering and biomechanical standards (e.g., ASTM F2565, ASTM F648, ISO 5834, ASTM F2759), which are used to evaluate characteristics like material properties, wear, and mechanical strength. The results are compared against these predetermined specifications to ensure safety and effectiveness.

8. The sample size for the training set:

• Not applicable. This device is a total knee system and its performance evaluation involves physical and mechanical testing, not a machine learning model that requires a training set.

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

• Not applicable. (See #8)

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