Search Results

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.

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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, osteoarthitis, 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.

The U2 Total Knee System include femoral components, patellar 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, Posterior Stabilized (PS) type and Ultracongruent (UC) type. The subject device, U2 Total Knee System, XPE Tibial Insert, Posterior Stabilized PLUS (PS PLUS), belongs to U2 Total Knee System PS type.

U2 Total Knee System, XPE Tibial Insert, PS PLUS (Subject device) is a constrained design insert mechanically locked with metallic tibial baseplate. It is manufactured from Gamma irradiated UHMWPE which conform to ASTM F2565-13, while the UHMWPE raw material is in accordance with ASTM F648-14 and ISO 5834-1:2005.

The Subject device is used with the Posterior Stabilized (PS) type Femoral Component. In comparison to the marketed predicate devices, the Subject device has slightly modified width and height of the post, the height of the anterior lip. The Subject device provides constraint in varus/valgus and internal/external rotation to enhance joint stability and resist paradoxical anterior femoral slide.

Except for the differences of the post and anterior lip, the size distribution the Subject device is identical to the previously cleared Tibial Inserts of U2 Total Knee System predicates. The Subject device is available in eight proportional sizes (#0~ #7) and ten thicknesses (thicknesses of poly insert + tibial baseplate: 9mm, 10mm, 11mm, 12mm, 13mm, 14mm, 15mm, 16mm, 17mm and 18mm). The minimum thickness of poly insert of Subject device is 6 mm on the bearing surface, identical to the primary predicate.

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. The surgical instruments have been previously cleared as part of the predicate devices.

This document describes the FDA's decision regarding the substantial equivalence of the "U2 Total Knee System, XPE Tibial Insert, PS PLUS" to a predicate device. It does not contain information about the acceptance criteria or study results in the context of an AI/ML medical device.

Therefore, I cannot provide the requested information about acceptance criteria, reported device performance, sample sizes, ground truth, expert qualifications, adjudication methods, or MRMC studies, as these details are not present in the provided text.

The document is purely a regulatory clearance notice for a knee implant, focusing on its manufacturing, materials, and intended use as compared to existing, legally marketed predicate devices.

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For E-XPE Insert (CR, PS and UC type) and Patella:
The 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 a single use implant and intended for cemented use only.

For E-XPE Insert (PSA type)
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 contraction. This device is intended for use in patients who require augmentation and/or stem extensions due to inadequate bone stock and/or require constrained stabilization for tibiofemoral joint due to soft tissue imbalance. This device is a single use implant and intended for cemented use only.

The subjected device includes E-XPE Tibial insert (CR, PS, UC and PSA type) and E-XPE Patella. It is an extension to the previously cleared "UNITED" U2 Total Knee System (K082424, K103733, K131864, K132752 and K150829). The design rationale and indication for use are identical to the previously cleared "UNITED" U2 Total Knee System.

The provided document is a 510(k) summary for the U2 Total Knee System E-XPE Products. It focuses on demonstrating substantial equivalence to pre-existing predicate devices for a medical device, specifically a knee implant. As such, it details pre-clinical performance data (mechanical tests) and explicitly states "None provided" for clinical performance data.

Therefore, it does not contain the information required to answer the prompt, which is about acceptance criteria and study results for an AI/algorithm-based medical device. The prompt is looking for details about an AI's performance, such as:

• Accuracy/performance metrics (e.g., sensitivity, specificity, AUC)
• Sample sizes for test and training sets related to image or data analysis
• Ground truth establishment by expert readers or pathologists
• Human-in-the-loop studies (MRMC studies)
• Adjudication methods for AI performance validation

None of this type of information is present in the provided text, as it describes a physical implant and its material/mechanical testing.

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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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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.

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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.

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