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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.

Ask a specific question about this device

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.

Ask a specific question about this device

For Tibial baseplate, CMA, #0
This device is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in sketetally mature patients with severe knee pain and disability due to rheumatoid arthritis, 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 surfaction or prior patellectorny, 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.

For Tibial insert, #0
The device is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in sketally mature patients with severe knee pain and disability due to rheumatoid arthritis, 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 a single use implant and intended for cemented use only.

The U2 Total Knee System consists of Femoral components, patella components, Tibial baseplate components and Tibial inserts components which are designed to be used together to achieve total replacement of the knee joint. This system includes Cruciate Retained (CR) type, Ultracongruent (UC) type, and Posterior Stabilized (PS) type.

The U2 Total Knee System, Tibial baseplate, CMA, #0 (Subject device) is a size extension of the cleared "UNITED" U2 Total Knee System, Tibial baseplate, CMA, #1 to #7 (K131864). The materials, indications, sterilization of this subject are identical to the cleared "UNITED" U2 Total Knee System, Tibial baseplate, CMA, #1 to #7 (K131864).

The U2 Total Knee System, Tibial insert, #0 (Subject device) is a size extension of the cleared "UNITED" U2 Total Knee System, Tibial insert, #1 to #7 (K051640, K103733, K131864, K132752, K150829 and K161705). The materials, indications, sterilization of this subject are identical to the cleared "UNITED" U2 Total Knee System, Tibial insert, #1 to #7 (K051640, K103733, K131864, K132752, K150829 and K161705). The Subject Tibial insert, CR, #0 and Tibial insert, PS, #0 have a more concave sagittal plane design while comparing to the marketed predicate devices

Surgical procedures with the use of the Subject device shall be performed with the support of orthopedic instrumentation, to facilitate their proper insertion and removal from the patient. All the surgical instruments have been cleared as part of the predicate devices.

This is a medical device clearance, not an AI/ML device. Therefore, the questions regarding AI/ML device evaluations (sample size, experts, adjudication, MRMC, standalone performance, ground truth establishment for training set, etc.) are not applicable.

The document describes the acceptance criteria and study for a Tibial baseplate and Tibial insert, which are components of a knee replacement system. This is a traditional medical device, not an AI/ML powered device. Therefore, the concepts related to AI/ML device performance such as ground truth, expert adjudication, train/test sets, effect size of AI assistance, etc., are not relevant to this document.

However, I can extract the information provided regarding the device's performance analysis and acceptance criteria, based on the non-clinical tests conducted.

Here's the summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

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

The document does not explicitly list 'acceptance criteria' with numerical targets and then 'reported device performance' side-by-side in a table format. Instead, it states that "the following non-clinical tests were conducted to evaluate the safety and effectiveness of the subjected device, and the test results indicated that this device is safe and effective." This implies that the device met the internal acceptance criteria for each test.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample sizes (number of devices tested) for the non-clinical tests. It also does not provide information about data provenance as these are laboratory-based mechanical tests, not clinical data sets.

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 a mechanical device, not an AI/ML device requiring expert ground truth for image interpretation or diagnosis.

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

Not applicable. This is a mechanical device. Adjudication methods are relevant for subjective interpretations, typically in clinical studies or AI/ML ground truth establishment.

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 a mechanical device, not an AI/ML device.

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

Not applicable. This is a mechanical device, not an AI/ML device.

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

Not applicable. For mechanical devices, "ground truth" is typically defined by engineering specifications, material properties, and mechanical test standards (e.g., ISO or ASTM standards) that define acceptable performance limits. The document states that the "non-clinical tests were conducted to evaluate the safety and effectiveness," implying adherence to established engineering and material science principles, but specific ground truth definition is not explicitly detailed in this summary.

8. The sample size for the training set

Not applicable. This is a mechanical device, not an AI/ML device that requires a training set.

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

Not applicable. This is a mechanical device, not an AI/ML device.

Ask a specific question about this device

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.

Ask a specific question about this device

The U2 Total Knee system 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 a single use implant and intended for cemented use only.

This subjected device includes femoral component, tibial insert, XPE tibial insert and ultracongruent insert. It is a size extension to the cleared "UNITED" U2 Total Knee System (K051640, K120507, K131864, K103733, K132752, and K140073). The indications, materials, design of this subject device are identical to the cleared "UNITED" U2 Total Knee System except for its dimension.

The provided text is a 510(k) summary for the U2 Total Knee System-Additional Sizes. This document outlines the regulatory filing for a medical device and typically focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed study proving the device meets specific performance acceptance criteria in terms of AI/software performance.

Therefore, many of the requested categories related to AI/software performance, such as sample size for test sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details, are not applicable to this type of regulatory submission for a physical knee implant.

However, I can extract information related to the device's non-clinical performance and its comparison to a predicate device, as that is the focus of this document.

Here's the breakdown of the information that can be extracted, and where applicable, a note on why certain information is not present:

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

The document does not explicitly state quantitative "acceptance criteria" for the non-clinical tests in the usual sense of a specific pass/fail threshold with reported numerical performance values against those thresholds. Instead, it states that the tests "demonstrated that this device is safe and effective." The demonstration of safety and effectiveness relies on the device having the "same basic design, intended use, materials and the same manufacturing method" as predicate devices, with the only difference being "dimension." The non-clinical tests listed below were performed to confirm performance characteristics.

Note: The document confirms these tests were conducted "in accordance with the Agency's, 'Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA'." This implies that the tests were designed and evaluated against established industry and regulatory standards, which serve as the implicit "acceptance criteria." However, the exact numerical criteria and specific results are not detailed in this summary.

2. Sample sizes used for the test set and the data provenance: Not applicable. This document describes physical device testing, not AI/software performance evaluation with a "test set" in the computational sense. The "tests" refer to laboratory-based mechanical and materials evaluations.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" establishment by experts in the context of image analysis or diagnostic AI is mentioned. Evaluations are based on engineering principles and test results.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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 a physical prosthetic device, not an AI software.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of conventional AI/software ground truth. The "truth" for this device lies in its compliance with engineering standards, material properties, and mechanical performance under simulated physiological conditions, benchmarked against predicate devices.

8. The sample size for the training set: Not applicable. This is not an AI/machine learning device.

9. How the ground truth for the training set was established: Not applicable.

Summary of the Study that Proves the Device Meets Acceptance Criteria (as described in the document):

The "study" refers to a series of non-clinical performance tests conducted on the U2 Total Knee System-Additional Sizes. The summary states these tests were performed "in accordance with the Agency's, 'Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA'".

The key premise for demonstrating safety and effectiveness and meeting acceptance criteria, as per this 510(k) summary, is substantial equivalence to several predicate devices (e.g., "UNITED" U2 Total Knee System K051640). The document explicitly states:

• "U2 Total Knee System, Additional Sizes has the same basic design, intended use, materials and the same manufacturing method as device of the 'United' U2 Total Knee System..."
• "The only difference between the cleared and subjected device is dimension."

The non-clinical tests listed above (Range of Motion, Contact Area and Pressure, Constraint, Fatigue Compression, Locking Strength, Fatigue Performance of Insert Spine, Material Properties) were performed to confirm that, despite the dimensional differences, the additional sizes maintain the same performance characteristics as the predicate devices, thereby ensuring safety and effectiveness. The conclusion provided is that "the test results demonstrated that this device is safe and effective."

Clinical Performance Data:
The document explicitly states: "None provided as a basis for substantial equivalence." This reinforces that the substantial equivalence determination for this submission relies entirely on non-clinical data and comparison to predicate devices, rather than new clinical trials for the specific additional sizes.

Ask a specific question about this device

The U2 Total Knee system 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 cannot be satisfactorily balanced and stabilized at the time of surgery.

For cemented femoral components, patellar components, tibial baseplate components and tibial inserts components: This device is a single use implant and intended for cemented use only.

For porous coated femoral component: This device is a single use implant and intended for cementless use only.

U2 Cemented Femoral Component-CR Type is manufactured from cast Co-Cr-Mo alloy confirming to ASTM F75. It is available in seven proportional sizes (#1~ #7, AP/ML ranging from 52mm/ 56mm to 76mm/ 80mm) and is provided in left and right configurations. The femoral component is the same as that of cleared U2 Total Knee System (K051640), except adding size #7. Fixation of the femoral component to the femur is achieved using bone cement.

1. Table of acceptance criteria and reported device performance:

Note: The document states that the submission was prepared in accordance with the "Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA." The specific quantitative acceptance criteria are not explicitly detailed in this summary but are implied to be those outlined in this guidance document.

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

• Sample size for the test set: Not applicable. The "Performance Data" section explicitly states "None provided as a basis for substantial equivalence" for clinical performance data. The device's safety and effectiveness were evaluated through non-clinical (bench) testing.
• Data provenance: Not applicable. No clinical data (which would have provenance) was provided.

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

• Not applicable. The study relies on non-clinical performance data (bench testing) rather than clinical data requiring expert review for ground truth.

4. Adjudication method for the test set:

• Not applicable. The study relies on non-clinical performance data (bench 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:

• Not applicable. This is a medical device (femoral component for knee replacement) and not an AI-powered diagnostic or assistive tool for human readers.

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

• Not applicable. This is a medical device and does not involve an algorithm. The "standalone" performance here would refer to the physical device's mechanical performance, which was assessed through bench testing as described in the "Non-clinical Performance" section.

7. The type of ground truth used:

• Bench Testing Standards: The ground truth for the non-clinical tests would be defined by established engineering and biomechanical standards (e.g., ASTM standards, or those referenced in the FDA's "Class II Special Controls Guidance Document") for the performance metrics being evaluated (e.g., range of motion, contact pressure, fatigue strength). The device's performance was compared against these predefined physical and mechanical thresholds for safety and effectiveness.

8. The sample size for the training set:

• Not applicable. This is a medical device, not an AI model.

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

• Not applicable. This is a medical device, not an AI model.

Ask a specific question about this device

The U2 Total Knee system 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 cannot be satisfactorily balanced and stabilized at the time of surgery.

For cemented femoral components, patellar components, tibial baseplate components and tibial inserts components: This device is a single use implant and intended for cemented use only.

For porous coated femoral component: This device is a single use implant and intended for cementless use only.

U2 Porous Coated Femoral Component-CR Type is manufactured from Co-Cr-Mo alloy confirming to ASTM F75. The inner surface is porous coated with Co-Cr-Mo beads (ASTM F75) to provide a porous surface for enhanced fixation. It is available in seven proportional sizes (#1~ #7, AP/ML ranging from 52mm to 76mm/ 80mm) and is provided in left and right configurations. The femoral component is the same as that of cleared U2 Total Knee System (K051640), except adding size #7.

The provided text describes a 510(k) submission for a medical device, the "U2 Femoral Component, CR, Porous Coated." This is a premarket notification to demonstrate that the device is substantially equivalent to a predicate device, and it primarily focuses on non-clinical performance data.

Therefore, the requested information regarding acceptance criteria, study details for AI performance, sample sizes for test/training sets, expert qualifications, ground truth establishment methods, and MRMC studies is not applicable or not provided in this type of submission. These details are typically associated with studies evaluating the performance of AI/CADe devices, which this document is not.

The device in question is a physical orthopedic implant, not a software or AI-based diagnostic tool. The performance data presented refers to mechanical and design-based tests.

Here's a breakdown of why each point of your request cannot be fully answered based on the provided document:

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

• Acceptance Criteria: Not explicitly stated as pass/fail thresholds against specific numerical values. The document states that "Tests as follows were conducted to evaluate the safety and effectiveness of the subjected device, and the test results demonstrated that this device is safe and effective." This implies all tests met their inherent safety and effectiveness requirements, but specific performance metrics and their acceptance benchmarks are not detailed.
• Reported Device Performance: The document lists the types of non-clinical tests performed, but does not provide the results or specific performance metrics from these tests. It only states that the tests "demonstrated that this device is safe and effective."

2. Sample sizes used for the test set and the data provenance

• Sample Size: Not applicable. The tests performed are non-clinical (e.g., mechanical tests on the implant itself), not involving human or clinical data.
• Data Provenance: Not applicable.

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

• Number of experts and qualifications: Not applicable. There is no "ground truth" to be established by experts as this is not a diagnostic device involving interpretation of data.

4. Adjudication method for the test set

• Adjudication method: Not applicable.

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

• MRMC study: No, this device is an orthopedic implant, not an AI or diagnostic tool. Thus, no MRMC study was performed.

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

• Standalone performance: No, this is not an algorithm or AI device.

7. The type of ground truth used

• Type of ground truth: Not applicable. For devices like this, safety and effectiveness are confirmed through established engineering and materials testing standards (e.g., ASTM F75 for Co-Cr-Mo alloy).

8. The sample size for the training set

• Training set sample size: Not applicable. This is not an AI/machine learning device that requires a training set.

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

• Ground truth establishment for training set: Not applicable.

Summary of Relevant Information from the Document:

• Device Type: U2 Femoral Component, CR, Porous Coated - a femoral component for total knee replacement, made from Co-Cr-Mo alloy and porous coated.
• Purpose of Submission: Demonstrate substantial equivalence to predicate devices (K051640 and K030612) by showing similar materials, design, manufacturing, and intended use, and adding a new size (#7).
• Performance Data: Non-clinical tests were conducted according to the "Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA."
• Specific Tests Performed (Non-clinical):
  • Range of Motion
  • Contact Area and Contact Pressure on Femorotibial Joint
  • Contact Area and Contact Pressure on Femoropatellar Joint
  • Subluxation of Femorotibial Joint
  • Fatigue Compression Test of Femoral Component
• Clinical Performance Data: "None provided as a basis for substantial equivalence." This further confirms that no studies involving human subjects or clinical outcomes were part of this specific 510(k) submission.

This 510(k) focuses on mechanical and physical properties of an implant, rather than the diagnostic accuracy or performance of a digital health or AI-driven device.

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The U2 Total Knee system 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 intended for cemented use only in the U.S.A.

The Ultracongruent Insert 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 with PCL incomplete, absent, nonfunctional or required release. It is used with the cruciate retained (CR) type Femoral Component. The anterior lip of Ultracruent Insert is more prominent when comparing with the U2 CR Insert (K051640, K103733), which increases the articulating surface area and expands the circumference to accommodate and stabilize the femur during knee flexion. The Ultracongruent Insert is available in seven proportional sizes (#1~ #7) and five thicknesses (thicknesses of insert + tibial baseplate: 9mm, 11mm, 15mm, and 18mm). The minimum thickness of Ultracongruent Insert is 6 mm on the bearing surface. It is manufactured from irradiated UHMWPE which conform to ASTM F2565, while the UHMWPE raw material is in accordance with ASTM F648 and ISO 5834.

The provided text describes a 510(k) summary for the "Ultracongruent Insert," a medical device. This document is a premarket notification for a new device claiming substantial equivalence to existing predicate devices. It does not contain information about a study that establishes acceptance criteria for performance metrics in the way you've outlined for AI/diagnostic devices (e.g., sensitivity, specificity, accuracy, expert consensus, MRMC studies).

Instead, this document details mechanical and material tests conducted to demonstrate the safety and effectiveness of the orthopedic implant. The "acceptance criteria" for such a device are typically related to meeting specific engineering standards and showing performance comparable to existing, legally marketed devices.

Here's an attempt to structure the information based on your request, highlighting what is present and what is absent:

Acceptance Criteria and Study for the Ultracongruent Insert

This document describes a 510(k) premarket notification for a medical device called the "Ultracongruent Insert," a component of a total knee system. The "studies" conducted for this type of device are primarily engineering and material tests, not clinical or diagnostic performance studies involving human readers or AI.

1. Table of Acceptance Criteria and the Reported Device Performance

Note: For a 510(k) submission, "acceptance criteria" for these engineering tests are often that the device performs equivalently to the predicate device(s) or meets established industry standards for mechanical strength, wear, and biomechanical function. The document states that "the test results demonstrated that this device is safe and effective," implying these criteria were met.

2. Sample Size Used for the Test Set and the Data Provenance

The document does not explicitly state the sample sizes for the mechanical tests. For engineered medical devices, sample sizes are typically determined by engineering standards (e.g., minimum number of samples for fatigue testing, static strength testing).

• Sample Size: Not specified in the provided text.
• Data Provenance: The tests were "conducted to evaluate the safety and effectiveness of the subjected device." The location of these tests (e.g., in-house, third-party lab) and country of origin of the data are not specified, but the applicant company is located in Taiwan. These are retrospective tests conducted on device prototypes/samples.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. This device is an orthopedic implant, not a diagnostic device requiring expert interpretation or ground truth establishment in a clinical sense. The "ground truth" for these tests relates to engineering specifications and performance benchmarks from predicate devices or industry standards.

4. Adjudication Method for the Test Set

Not applicable, as this is not a study involving human interpretation or clinical adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This type of study is relevant for diagnostic devices where human readers interpret medical images or data. This document describes an orthopedic implant.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No. This concept is applicable to AI algorithms. This document describes a physical medical implant.

7. Type of Ground Truth Used

The "ground truth" for this device's evaluation is based on:

• Engineering Standards: Conformity to ASTM and ISO material standards.
• Predicate Device Performance: Demonstrating comparable mechanical and material performance to legally marketed predicate devices.

8. Sample Size for the Training Set

Not applicable. There is no "training set" in the context of an AI algorithm or a diagnostic model for this type of device submission.

9. How the Ground Truth for the Training Set Was Established

Not applicable. No training set or associated ground truth establishment process is relevant for this device.

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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.

Ask a specific question about this device

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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