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This product is indicated for temporary use (maximum of 180 days) as a total knee replacement (TKR) in skeletally mature patients undergoing a two-stage procedure due to a septic process.

This product is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g., resection arthroplasty, fusion, etc.). During the implantation period, patients have to use traditional mobility assist devices (e.g. crutches, walkers, canes) for daily activities.
With pre-clinical validations of antibiotic elution, tibial spacer fatigue test, and knee spacer wear test, only Palacos MV+G bone cement may be used for preparing the spacers.

Cellbrick Knee Spacer is a temporary knee spacer product, it's suitable for the patients with mature skeleton and required to perform two-stage knee joint prosthesis procedure for infection control. It consists of three components, which are (1) Femoral Spacer, (2) Tibial Spacer, and (3) Canal Rod. The Femoral Spacers and the Tibial Spacers are designed with multiaperture features, which can act as carrier of antibiotic-loaded bone cement to release antibiotic at infection site. The Canal Rod is optional.

• Femoral Spacer
  The Femoral Spacer is made of UHMWPE (ASTM F648/ISO5834-2). The geometrical appearance of Femoral Spacer is designed and modified based on the 510(k) cleared cruciate-retaining femoral component (K140073). Their articular surface geometry and curvature is identical. In addition, the Femoral Spacer is designed with multiaperture feature. Such scaffold-like features can use as a carrier of antibiotic-loaded cement to release antibiotic at the infection site for infection control.
  The Femoral Spacer can be used for both of left and right knee because of the symmetric condyle design. Five femoral spacer sizes have been prepared for different anatomical demands with anteroposterior (AP) and mediolateral (ML) dimensions. The Femoral Spacer is designed “same/ one up" sizing options with the tibial spacers.
• Tibial Spacer
  The Tibial Spacer is made of UHMWPE (ASTM F648/ISO5834-2). The bearing surface's curvature and geometrical design of the tibial spacer is the same as the 510(k) cleared ultra-congruent tibial insert (K132752, K150829, and K222700). The Tibial Spacer is designed with multiaperture feature as well. This scaffold-like feature is used as a carrier of antibiotic-loaded cement to release antibiotic at the infection site for infection control.
  Five Tibial Spacer sizes have been prepared for different anatomical demands with anteroposterior (AP) and mediolateral (ML) dimensions.
• Canal Rod
  The canal rod is made of Ti-6Al-4V alloy (ASTM F136/ISO 5832-3). As a carrier, the rod provides the area for cement to attach so that to increase the surface area of cement. The canal rod is an optional device, it could be applied to patient with deeper infection problem, applying Canal Rod can make surgeon placing antibiotic-loaded cement into the deeper infection site. The Canal Rod is provided with one dimension: Ø 4(diameter) ×80mm (length).

The provided text is a 510(k) summary for the "Cellbrick Knee Spacer". It describes the device, its intended use, and compares it to predicate devices. However, the document does not contain any information about acceptance criteria or a study proving that an AI/ML device meets acceptance criteria.

The requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) is all highly relevant to the evaluation of AI/ML-driven medical devices. Since the Cellbrick Knee Spacer is described as a physical implant (femoral spacer, tibial spacer, canal rod made of UHMWPE and Ti-6Al-4V alloy) and not a software or AI/ML product, the submission details focus on pre-clinical validations for physical properties like antibiotic elution, wear tests, fatigue tests, range of motion, constraint performance, and endotoxin testing.

Therefore, I cannot provide the requested information as it is not present in the provided document. The document describes a physical medical device clearance, not an AI/ML device validation.

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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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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 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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