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The Columbus Total Knee System (CR) is indicated for use in reconstruction of the diseased knee joint caused by osteoarthritis, rheumatoid arthritis, post-traumatic 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.

The Columbus Knee (CR) is designed for use with bone cement.

The cemented Columbus Knee System (CR) is available with one femoral design, the Cruciate Retaining (CR) which retains the ligament (PCL) during implantation. The design of the femoral component, and tibial plateau (tray) are manufactured from CoCrMo. The tibial "gliding surfaces" (inserts) and patellas are manufactured from UHMWPE.

This document describes a 510(k) premarket notification for the "Columbus Total Knee System (CR)", a medical device. The information provided is for regulatory clearance based on substantial equivalence, not a detailed clinical study demonstrating device performance against specific acceptance criteria. Therefore, most of the requested information about device acceptance criteria and a study proving it cannot be extracted from this document.

Here's an analysis of what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

There is no explicit table of acceptance criteria or reported device performance against such criteria. The document states:

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

• Sample Size (Test Set): Not applicable. This document does not describe a clinical study with a test set of patients. It refers to "Biomechanical testing results," which typically involve laboratory tests on the device itself, not human subjects.
• Data Provenance: Not applicable.

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

• Not applicable. There is no mention of experts establishing ground truth for a test set in the context of this 510(k) submission.

4. Adjudication method 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. The Columbus Total Knee System is a mechanical implant; it does not involve AI or human "readers" in the context of a diagnostic or assistive technology.

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

• Not applicable. This is a medical implant, not an algorithm.

7. The type of ground truth used:

• Not applicable in the sense of a clinical study with a "ground truth" derived from patient outcomes. The "ground truth" here is implied by the "Draft Guidance for the Preparation of Premarket Notifications (510(k)s) for Cemented, Semi-constrained Total Knee Prostheses," which outlines the required biomechanical tests and standards for demonstrating safety and effectiveness. The "ground truth" is adherence to these established engineering and mechanical performance parameters, and comparison to predicate devices.

8. The sample size for the training set:

• Not applicable. This document does not describe the development or testing of an AI model, so there is no training set mentioned.

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

• Not applicable.

Summary of Relevant Information from the Document:

The Columbus Total Knee System (CR) received 510(k) clearance by demonstrating "substantial equivalence" to legally marketed predicate devices. This equivalence was supported by:

• Biomechanical testing: "All required testing per 'Draft Guidance for the Preparation of Premarket Notifications (510(k)s) for Cemented, Semi-constrained Total Knee Prostheses' were completed. Biomechanical testing results demonstrate the Columbus Knee System is substantially equivalent to other knee systems currently on the market."
• Predicate Devices:
  • Search Evolution Total Knee System (K021313)
  • Scorpio Posterior Cruciate Retaining Knee System (K974556)
  • Gem Knee System (K994214)

In essence, the "acceptance criteria" for this device's regulatory clearance were met by fulfilling the requirements of the FDA's guidance document for knee prostheses and proving its performance via biomechanical testing was comparable to existing, legally marketed devices. The study proving this involves the aforementioned biomechanical tests, but the document does not provide details on their methodology, sample sizes (e.g., number of test specimens), or specific quantitative results beyond the statement of substantial equivalence.

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