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Columbus Total Knee System, Columbus Revision Knee System, EnduRo Knee System are indicated for use in reconstruction of the diseased knee joint caused by osteoarthritis, rheumatic arthritis, the need to revise failed arthroplasties or osteotomies where pain, deformity or dysfunction persist, and for patients suffering from correctable valgus or varus deformity and moderate flexion contracture.

Posterior Stabilized (PS) components are also for absent or non-functioning posterior cruciate ligament and severe anteroposterior instability of the knee joint.

Hinge Knee Systems are designed for use in patients in primary or revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments are absent or insufficient. The femoral and tibial augments are to be attached to their respective components with a fixation screw or screws.

The Columbus Total Knee System, Columbus Revision Knee System are designed for use with bone cement.

The VEGA patella is manufactured from Ultra High Molecular Weight Polyethylene (UHMWPE) that incorporates a wrought stainless steel radiographic marker. The VEGA patella is intended to articulate with the femoral and tibial components of the Columbus Total Knee System, Columbus Revision Knee Svstem or EnduRo Knee System.

The VEGA patella is sterile and intended for single use only.

The provided text describes a 510(k) premarket notification for a medical device (Columbus Total Knee System, Columbus Revision Knee System, EnduRo Knee System) and a line extension (VEGA patella). This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with acceptance criteria and performance metrics in the way a diagnostic AI/ML device would.

Therefore, many of the requested categories for acceptance criteria and study details are not applicable or cannot be extracted from this type of regulatory submission. The document primarily details the device, its intended use, and its substantial equivalence to a previously cleared device.

However, I can provide information relevant to your request based on the type of data presented in this regulatory document.

Here's a breakdown of the information that can be extracted, along with explanations for categories that are not applicable:

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

The document does not present acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy) or a quantitative study with reported results in the typical sense of a diagnostic device. Instead, the acceptance criteria implicitly relate to demonstrating substantial equivalence to a predicate device, and the "performance" data refers to assessments supporting this equivalence.

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

• Sample Size: Not applicable. This document refers to engineering analyses (geometrical comparison, lateral stability evaluation) rather than a clinical study with a "test set" of patients or cases. The "sample" would be the device designs themselves.
• Data Provenance: Not applicable for the reasons above. This is an engineering and design-based assessment.

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

• Number of experts: Not applicable. This type of submission relies on engineering principles and regulatory assessment, not expert consensus on ground truth in a clinical context.
• Qualifications of experts: Not applicable.

4. Adjudication method for the test set

• Adjudication method: Not applicable. There is no clinical test set requiring adjudication in this context.

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: Not applicable. This document is for a knee implant system, not a diagnostic AI/ML device.

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

• Standalone performance: Not applicable. This document is for a medical implant, not an algorithm or AI system.

7. The type of ground truth used

• Ground truth: The "ground truth" implicitly used here is that the predicate device (Aesculap VEGA Knee System with the VEGA patella) is safe and effective when marketed. The current submission aims to demonstrate that incorporating the VEGA patella into the Columbus and EnduRo systems maintains substantial equivalence to this established "ground truth" represented by the predicate device's clearance. The assessments mentioned (geometrical comparison, lateral stability) are engineering approaches to confirm this equivalence.

8. The sample size for the training set

• Sample size for training set: Not applicable. This is not an AI/ML device and therefore does not have a "training set" in that sense. The "development" would involve engineering design and possibly bench testing, not machine learning training.

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

• Ground truth for training set: Not applicable (not an AI/ML device).

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