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Joint replacement is indicated for patients suffering from disability due to:

• · degenerative, post-traumatic or rheumatoid arthritis;
• · avascular necrosis of the femoral condyle;
• · post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy;
• · moderate valgus, varus or flexion deformities;
• · treatment of fractures that are unmanageable using other techniques.

This device may also be indicated in the salvage of previously failed surgical attempts. All devices are intended for cemented applications except for the 3DKNEE™ Porous Coated Femur, EMPOWR Porous™ Knee Femur and EMPOWR Porous™ Knee Tibia which are intended for cementless applications.

While knee replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients.

The EMPOWR Varus / Valgus Constrained (VVC) Tibial Insert and accessory is a line extension to the EMPOWR Knee platform (cleared via K143242), to include a more constrained tibial insert component that provides additional internal / external and varus / valgus rotational stability, which provide surgeons with comprehensive surgical solutions to address a variety of patient demographics and surgeon preferences.

The provided text is a 510(k) summary for the EMPOWR VVC Tibial Insert, a medical device. This document focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing. It explicitly states that clinical testing was not required. As such, the information typically found in a study proving the device meets acceptance criteria, an MRMC study, or a standalone algorithm performance study is not present. The document focuses on mechanical testing.

Here's the breakdown of what can and cannot be extracted from the provided text regarding acceptance criteria and studies:

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

The document lists "Non-Clinical Testing" that was performed, implying that the results of these tests met certain acceptance criteria, but the specific numerical acceptance criteria and the detailed reported performance values are not provided. The conclusion states, "All testing has determined that the device is substantially equivalent to the predicate devices," which implies that the device did meet the acceptance criteria, whatever they were.

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

This information is not provided in the document. The Non-Clinical Testing section describes types of mechanical tests but does not specify sample sizes for these tests or data provenance beyond "All testing has determined that the device is substantially equivalent to the predicate devices."

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

This information is not applicable as the document describes mechanical, non-clinical testing, not a study involving human experts or ground truth establishment in a clinical sense.

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

This information is not applicable as the document describes mechanical, non-clinical 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

This information is not applicable. The device is a medical implant (Tibial Insert), not an AI-powered diagnostic or assistive tool for human readers. Additionally, the document explicitly states: "Clinical Testing: Clinical testing was not required."

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

This information is not applicable. The device is a physical medical implant, not a standalone algorithm.

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

For the non-clinical tests, the "ground truth" would be established by engineering standards, manufacturing specifications, and the performance characteristics of the predicate devices. The document implies that the device's performance met these engineering and substantial equivalence criteria. No clinical "ground truth" (like pathology or outcomes data) was used or required.

8. The sample size for the training set

This information is not applicable. There is no "training set" as this is a physical medical device undergoing mechanical testing, not a machine learning model.

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

This information is not applicable for the same reason as point 8.

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When used with the components of the Consensus Knee System:

The CONSENSUS® KNEE SYSTEM Primary Knee is designed as a system and is not intended for substitution of components from other systems.

• A. Primary intervention of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, or degenerative arthritis.
• B. Failed osteotomy or unicompartmental replacements.
• C. Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone stock exists.
• D. The non-porous (uncoated and coated with CoCr beads without Titanium) components may only be used with cement.
• E. The porous coated (CoCr beads with Titanium) components may be used with or without cement.

When used as a component of the Consensus Revision Knee System:

The Consensus® Revision Knee System is designed as a system and is only intended to be used with compatible components of the Consensus® Knee System. The revision knee femoral and tibial components are intended for cemented use only.

The indications for use are:

• A. Primary intervention of rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, and/or avascular necrosis of the femoral condyle.
• B. Post-traumatic loss of joint configuration (particularly when there is patellofemoral erosion. dvsfunction, or prior patellectomy)
• C. Failed osteotomy or unicompartmental replacements.
• D. Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone stock exists.
• E. The salvage of previously failed surgical attempts if the knee can be satisfactorily balanced and stabilized at the time of surgery
• F. Moderate valgus, varus, or flexion deformities

The VitalitE Tibial Insert is a vitamin E version of the UHMWPE tibial insert that has been a component of both the Consensus Knee System (CKS) and the Consensus Revision Knee System (RKS). The new insert still serves as the gliding surface between the metallic femoral component and the metallic tibial base plate of these knee systems. The new VitalitE insert will also be available in a cruciate retaining (CR) or ultra-congruent/ PCL substituting designs in sizes 0 through 6 and in thicknesses from 10 to 22 mm. The proprietary locking mechanism design on the underside of the insert will remain unchanged. The only difference will be the vitamin E additive in the UHMWPE which is a-tocopherol. This is the exact same polymer that is used in the Consensus VitalitE Acetabular insert but with a slightly lower radiation dose. Consensus will also offer our current CKS all-poly patellae in the new vitamin E UHMWPE material. This includes both the round and oval configurations with either a 7.5 mm or 10 mm thickness.

This document describes the 510(k) premarket notification for the Consensus Orthopedics VitalitE Tibial Insert & Patellar Components. This is a medical device, and the evaluation for such devices often focuses on substantial equivalence to existing legally marketed predicate devices, rather than a direct clinical performance study that proves specific acceptance criteria for a new AI/software device.

Therefore, the requested information elements (especially those related to AI/software performance metrics like sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, and specific ground truth establishment methods) are not applicable in the context of this 510(k) submission for a physical medical implant.

However, I can extract the relevant information regarding the acceptance criteria and how the device meets them based on the provided text, reinterpreting some of your categories to fit the context of a physical implant's regulatory review.

Here's the breakdown:

Acceptance Criteria and Device Performance for Consensus Orthopedics VitalitE Tibial Insert & Patellar Components

The core "acceptance criteria" for this device, within the scope of a 510(k) submission, revolve around demonstrating substantial equivalence to existing predicate devices. This means showing that the new device is as safe and effective as a legally marketed device that does not require premarket approval (PMA).

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not specified in terms of specific number of units for each bench test. For physical implant testing, "worst-case" scenarios are typically selected rather than a large statistical sample of every size/type. The document mentions "a range of various sizes and types of inserts" for the disassembly testing.
• Data Provenance: The data appears to be from internal bench testing and analysis conducted by Consensus Orthopedics, Inc. The document doesn't specify country of origin for the data, but the company is based in El Dorado Hills, CA, USA, implying the testing likely occurred in the US or at a certified lab. The data is retrospective in the sense that it was generated for this specific submission to demonstrate equivalence to already marketed devices.

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

• Not applicable in the context of this 510(k) for a physical implant. "Ground truth" as a concept with expert consensus is typically used for AI/software devices where human interpretative judgment is being compared to an algorithm's output. For physical implants, "ground truth" is established through engineering and material science standards, validated testing methods, and regulatory requirements (e.g., ISO standards, ASTM standards, FDA guidance).

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

• Not applicable. Adjudication methods like 2+1 or 3+1 are used for reconciling discrepancies in human expert interpretations, especially in clinical image analysis for AI. For engineering bench testing, results are typically quantitative and compared against predefined pass/fail criteria or against control/predicate device performance.

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. MRMC studies are specific to evaluating inter-reader variability and the impact of AI assistance on human performance, primarily in imaging diagnostics. This submission is for a physical knee implant.

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

• Not applicable. This device is a physical knee implant, not an algorithm.

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

• For physical implants demonstrating substantial equivalence, the "ground truth" is typically a combination of:
  • Validated engineering standards: e.g., ASTM standards for mechanical properties and wear.
  • Biocompatibility standards: demonstrating the material is safe for implantation.
  • Performance of legally marketed predicate devices: The "known good" performance of existing devices serves as the benchmark.
  • Material characterization: Chemical composition, physical properties, and manufacturing integrity are verified against specifications.

8. The sample size for the training set:

• Not applicable. There is no "training set" in the context of a 510(k) for a physical medical device. This concept is relevant for machine learning algorithms.

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

• Not applicable. As above, there is no training set for this type of device.

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