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U2 Total Knee System - PF+ 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 joint surface erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion deformities. 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. Femoral Component, PF+, Tibial Baseplate, PF+, Tibial Extension Stem, Patella, Onset, E-XPE, PF+, and Patella, Asymmetric Onset, E-XPE, PF+ are indicated for both cemented and cementless use.

USTAR II Total Knee System

1. Metastatic tumor (i.e. osteosarcoma, chondrosarcoma, giant cell tumor or osteoma) where massive resection and transplantation are needed.
2. Severe knee joint damage resulting from trauma where massive resection and transplantation are needed.
3. Non-inflammatory degenerative joint disease such as avascular necrosis, osteoarthritis, or traumatic arthritis.
4. Revision of previously failed total joint arthroplasty, osteotomy, or arthrodesis.
5. Joint instability resulting from excessive bone resection.

For Femoral component, Hinged/ Tibial baseplate, Hinged/ Cemented tibial stem/ Cemented Straight stem, RHS, non coated/ Cemented Curved stem, RHS, non coated/ Cemented Straight stem, RHS/ Cemented Curved stem, RHS/ Tibial Augment: These devices are single use implant and intended for cemented use only.

For Distal Femoral Component, RHS/ Proximal Tibial Component, RHS/ Tibial stem/ Segment Part, RHS/ Segment Part, RHS, Bridge: These devices are single use implant and intended for cementless use only.

The subject PF+ Patella is a line extension of the U2 Total Knee System, and is compatible to the USTAR II System. The subject device, U2 Total Knee System–PF+ Patella; USTAR II System - PF+ Patella, is a Metal-Backed Patella, indicated for both cemented or cementless application. There are two variations available: (1) Patella, Onset, E-XPE, PF+, and (2) Patella, Asymmetric Onset, E-XPE, PF+. Patella, Onset, E-XPE, PF+ is a symmetric, dome-type metal-backed patella, and Patella, Asymmetric Onset, E-XPE, PF+ is an asymmetric, anatomic-type patella. Each type is available in five sizes. The body of PF+ patella is manufactured from Vitamin E blended highly cross-linked UHMWPE (ASTM F2695, ASTM F648/ISO5834-1), while the part of the metal back and the three pegs are produced by additive manufacturing according to the FDA guidance "Technical Considerations for Additive Manufactured Medical Devices - Guidance for Industry and Food and Drug Administration Staff", "Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement", and "Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Post market Surveillance Requirements." The metal back is made of Ti-6Al-4V alloy (ASTM 2924) and has a porous Ti structure on the bone side, peg side, and poly side. All types of PF+ Patella are compatibility with "United" U2 Total Knee System-Femoral components (K051640, K120507, K140073, K140075, K150829, and K150832), Femoral component, PSA (K082424), Femoral components, PF+ (K221705), and USTAR II System-Femoral components (K190100).

The provided text is a 510(k) Clearance Letter from the FDA for a total knee system. It details the device's name, regulation, a summary of its description, intended use, and a comparison to predicate devices, along with a list of non-clinical tests conducted.

However, the document specifically states "No clinical data is necessary." This means that the clearance was not based on a clinical study demonstrating the device's performance against detailed acceptance criteria in human patients with the format typically requested in your prompt (e.g., sensitivity, specificity, human-in-the-loop performance, ground truth establishment by experts, etc.).

Instead, the clearance is based on the substantial equivalence of the new device to existing legally marketed predicate devices, primarily through non-clinical testing and technological comparison.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance from a clinical study, as no such study was presented or required for this 510(k) clearance.

The "acceptance criteria" for this device, as implied by the FDA clearance, revolve around demonstrating that its technological characteristics and non-clinical performance are substantially equivalent to already cleared devices.

Here's what I can extract from the document regarding the non-clinical tests that functionally served as part of the "proof" that the device meets some form of performance criteria:

Summary of Non-Clinical Tests (Implicit Acceptance Criteria & Performance):

Since no clinical study was conducted or referenced in this 510(k) clearance documentation, the following points of your request cannot be addressed from the provided text:

• Sample size used for the test set and data provenance: Not applicable, as no clinical test set was used. The non-clinical tests were performed on device prototypes or samples.
• Number of experts used to establish the ground truth... / qualifications of those experts: Not applicable. Ground truth for clinical performance was not established.
• Adjudication method for the test set: Not applicable.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done...: Not applicable.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an AI algorithm.
• The type of ground truth used: For the non-clinical tests, the "ground truth" is defined by established engineering and material science standards and methodologies (e.g., ASTM standards for material properties, mechanical testing protocols).
• The sample size for the training set: Not applicable. This is a physical device, not an AI model requiring a training set.
• How the ground truth for the training set was established: Not applicable.

In essence, this 510(k) clearance is a regulatory determination of substantial equivalence based on non-clinical performance data and technological comparisons to predicate devices, not on a clinical trial demonstrating performance against specific diagnostic or treatment outcome acceptance criteria in humans.

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U2 Total Knee System - PF+ 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, primary and secondary traumatic arthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral joint surface erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion deformities. 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. Femoral Component, PF+, Tibial Baseplate, PF+ and Tibial Extension Stem are indicated for both cemented and cementless use.

There are three components included in U2 Total Knee System- PF+ for this 510k, (1)Femoral Component, PF+, (2)Tibial Baseplate, PF+, and (3)Tibial Extension Stem. Both Femoral Component, PF+ and Tibial Baseplate, PF+ can collocate with U2 Total Knee System tibial insert and patellar component (K021657, K051640, K082469, K103733, K131864, K132752, K150829, K152430, K161705, and K210961). This system includes Cruciate Retained (CR) type and Posterior Stabilized (PS) type.

• Femoral Component, PF+
There are two types of Femoral Component, PF+ : Cruciate Retaining type and Posterior Stabilized type. Femoral Component, PF+ is manufactured from cast Co-Cr-Mo alloy conforming to ASTM F75. The inner surface is coated with Co-Cr-Mo beads and Co-Cr-Mo powder (ASTM F75) to provide a porous surface to achieve biological fixation.

• Tibial Baseplate, PF+
Tibial Baseplate, PF+ is manufactured from titanium alloy (ASTM F620) which is forged by titanium alloy bars (ASTM F136). The backside of the subject device is coated with Titanium powder (ASTM F1580).

• Tibial Extension Stem
Tibial Extension Stem is collocated with tibial baseplate. The subject device is made of titanium alloy conforming to ASTM F136.

The provided document (K221705) is a 510(k) summary for a medical device called the "U2 Total Knee System-PF+". This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to legally marketed predicate devices.

It is crucial to understand that this document describes a mechanical orthopedic implant (knee replacement components), not an AI-powered or software-based medical device. Therefore, the concepts of acceptance criteria for AI performance, training and test sets for AI models, expert ground truth for imaging, MRMC studies, or standalone algorithm performance are not applicable to this submission.

The document discusses acceptance criteria and proof of meeting them, but these relate to the mechanical and material properties, biocompatibility, and sterilization of the knee implant components, not to the performance of an AI algorithm.

Therefore, I cannot provide the requested information for an AI-powered device based on this document.

However, I can extract information relevant to the device's performance, which is related to its mechanical and material integrity:

Information from the document relevant to the device's "performance" (mechanical/material):

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

The document broadly states that "the test results indicated that this device is safe and effective" and that "Verification activities on Subject devices demonstrated equivalent safety and effectiveness as compared to the predicate devices."

Specific acceptance criteria (e.g., "fatigue strength must exceed X N at Y cycles") and the exact reported values are not explicitly provided in a table format within this 510(k) summary. The summary typically refers to the fact that these tests were conducted and met the necessary standards for substantial equivalence.

However, the types of performance tests conducted are listed:

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

• Sample Size: Not explicitly stated for each mechanical test. For mechanical testing of components, samples typically refer to a number of physical units or prototypes tested, not patient data.
• Data Provenance: The tests are performed by the manufacturer, United Orthopedic Corporation (located in Hsinchu City, Taiwan). The testing is primarily laboratory-based mechanical and material characterization, not clinical data. Therefore, concepts like "country of origin of the data" or "retrospective/prospective" in the clinical sense are not applicable.

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):

This question is not applicable. This device is a mechanical implant, not an AI system interpreting medical images. "Ground truth" in this context would be defined by engineering specifications, material standards (e.g., ASTM F75, F136, F620, F1580), and validated test methodologies (e.g., fatigue testing standards). The "experts" involved would be materials scientists, mechanical engineers, and quality assurance professionals, whose qualifications are implicit in the adherence to recognized standards.

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

This question is not applicable. Mechanical tests have specific physical or chemical endpoints determined by validated methods and equipment, not human subjective interpretation requiring adjudication.

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:

This question is not applicable. MRMC studies are for assessing diagnostic accuracy of imaging or AI systems with human readers. This device is a mechanical implant.

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

This question is not applicable. This device is a mechanical implant.

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

The "ground truth" for this device's performance is established by:

• Adherence to international and national standards for materials (e.g., ASTM F75, F136, F620, F1580).
• Validated mechanical testing methodologies (e.g., fatigue testing, surface finish measurements).
• Biocompatibility standards (e.g., USP for endotoxin).
• Comparison to the established performance characteristics of predicate devices.

8. The sample size for the training set:

This question is not applicable. There is no AI model or "training set" for this mechanical device.

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

This question is not applicable.

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