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The device is indicated for use in total knee arthroplasty in skeletally mature patients with the following conditions:

1. Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
2. Collagen disorders, and/or avascular necrosis of the femoral condyle.
3. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
4. Moderate valgus, varus, or flexion deformities.
5. The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.

The device includes Cruciate Retained (CR) type, Posterior Stabilized (PS) type and Ultracongruent (UC) type. CR and UC types are designed to collocate with CR femoral component, while PS type is designed to collocate with PS femoral component.

This device is a single use implant and intended for cemented use only.

All Poly Tibial Components are made of Ultra High Molecular Weight Polyethylene (UHMWPE), including Cruciate Retained (CR) type, Posterior Stabilized (PS) type and Ultracruent (UC) type. All types are available in sizes #0~#7 (ranging from 39.5mm/60mm AP/ML to 58mm/84mm AP/ML) with ten thickness options (9mm, 10mm, 11mm, 12mm, 13mm, 14mm, 15mm, 16mm, 17mm and 18mm). The CR type of All Poly Tibial Component is intended to accommodate the posterior cruciate ligament (PCL) if it is present. The PS type and UC type are intended to be used in situation where the posterior cruciate ligament is absent or cannot be preserved. All Poly Tibial Components can be used with femoral components of U2 Total Knee System and patella (K021657, K103733, K051640 and K082469) in primary or revision total knee arthroplasty. CR and UC types are designed to collocate with CR femoral component (K140073, K150829, K140075 and K150832) while PS type is designed to collocate with PS femoral component (K051640, K120507 and K150829). The X-ray marking wire which is made of Co-20Cr-15W-10Ni alloy is embedded in the All Poly Tibial Component for X-ray image identification purpose.

I am sorry, but based on the provided text, there is no information about acceptance criteria, reported device performance, sample sizes, data provenance, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, or ground truth establishment for a device that uses AI or machine learning.

The document describes a medical device called "All Poly Tibial Component," which is a knee implant. The "Performance Data" section explicitly states "Non-clinical Performance" and lists mechanical tests like Range of Motion, Contact Area and Contact Pressure, Constraint Test, Wear Simulation Test, and Fatigue Test. It also explicitly states "Clinical Performance Data/Information: None provided as a basis for substantial equivalence."

Therefore, I cannot provide the requested information.

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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, 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 is intended for use in patients who require augmentation and/or stem extensions 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.

"UNITED" Augment and Screw - PSA Type, including femoral augments - distal only and tibial augments, is an extension of cleared "UNITED" U2 Total Knee System -PSA Type (K082424). The raw materials, safety and effectiveness of this subject device are identical to the "UNITED" U2 Total Knee System - PSA Type (K082424), except for increasing their thickness and modifying the shape to mimic anatomy. Femoral augment - distal only made of Co-Cr-Mo alloy (ASTM F75 or ASTM F1537) are available in 12 mm and 16 mm thickness and can be positioned on either side of femoral component. This component is only available distally. Tibial augments are made of Ti-6Al-4V alloy (ASTM F136/ISO 5832-3) and with 15 mm thickness. The periphery of the distal end of tibial augments is larger than that of the proximal end. It is left/right specific. The femoral augments and tibial augments are sized to match the femoral components and tibial base plates, respectively. There are 6 sizes (sizes #1 through 6) to match the corresponding augmentable femoral components - PSA type and tibial baseplates - PSA type (K082424). The augments are affixed to the tibial and femoral components with screw fixation and that the implant construct as a whole is to be fixed with cement. This device should not be used with another manufacturer's total knee systems since dimensional compatibility cannot be assured. It also should not be used with U2 Total Knee System - PS Type and CR Type. For total knee replacement, "UNITED" patella components (K021657, K051640, K082469, and K103733) are intended to be used with U2 Total Knee System - PSA Type (K082424) and the subject device.

The provided text is a 510(k) summary for the "Augment and Screw, PSA Type" knee system. This document focuses on demonstrating substantial equivalence to predicate devices, primarily through engineering and manufacturing comparisons rather than clinical performance data typical of AI/ML devices. Therefore, many of the requested fields are not applicable to this type of submission.

Here's an analysis of the provided information relative to your request:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The document states, "The locking strength evaluation between femoral component and femoral augment, as well as tibial baseplate and tibial augment completed as part of the design assurance process, demonstrated that this device is substantially equivalent to the predicate device." Acceptance criteria for "locking strength" are not explicitly quantified (e.g., minimum Newtons of force, cycles endured), but the conclusion is that the new device performs equivalently to established predicate devices.

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

• Sample Size: Not explicitly stated. The performance data section refers to "locking strength evaluation," implying mechanical testing rather than a clinical dataset. The number of samples tested for this evaluation is not provided.
• Data Provenance: Not applicable in the traditional sense of clinical data. This is a mechanical engineering evaluation of a physical device.

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

• Not Applicable. Ground truth, in the context of AI/ML, refers to human annotations or confirmed diagnoses used for model training and validation. For this mechanical device, "ground truth" would be the measured physical properties during testing, likely assessed against engineering specifications by qualified engineers or technicians, though their qualifications are not detailed.

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

• Not Applicable. Adjudication methods are typically used to resolve discrepancies among expert opinions in clinical ground truth establishment. This document describes mechanical testing.

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. This is a hardware device (knee augment and screw) and not an AI/ML-driven device that assists human readers. Therefore, an MRMC study is not relevant to this submission.

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

• No. This is a hardware device. "Standalone performance" in the context of AI/ML refers to the algorithm's performance without human intervention. This concept does not apply here.

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

• Mechanical Test Results/Engineering Specifications. The "ground truth" for this device's performance would be the direct measurements from mechanical tests (e.g., force required for failure, displacement under load) compared against established engineering standards or the performance of predicate devices.

8. The sample size for the training set:

• Not Applicable. There is no "training set" in the context of an AI/ML model for this hardware device. The device's design is based on engineering principles and iterative design assurance processes, not machine learning.

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

• Not Applicable. See point 8.

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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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