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The Columbus Total Knee System (PS) 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.

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

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

The cemented Columbus Knee System (PS) is available with one femoral design, the Posterior Stabilizing (PS) which offers stabilization if the ligament (PCL) is absent, weakened or sacrificed 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.

The provided text describes the Columbus Total Knee System and its 510(k) summary. However, it does not contain information about acceptance criteria for a study, nor does it detail a study proving device performance against such criteria.

The document is a submission to the FDA for market clearance (510(k)). This type of submission relies on demonstrating substantial equivalence to already legally marketed devices, rather than conducting new clinical trials to prove performance against specific acceptance criteria.

The "PERFORMANCE DATA" section (page 1 of 2 in {1}) states:

"All required testing per 'Draft Guidance for the Preparation of Premarket Notifications (510(k)s) for Cemented, Semi-constrained Total Knee Prostheses' were completed.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."

This indicates that standard biomechanical tests relevant to knee prostheses were performed to show that the new device behaves similarly to existing, approved devices. It does not provide specific acceptance criteria or detailed study results in the format requested.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided text.

To directly answer your numbered points based on the provided text, while acknowledging the absence of the requested data:

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

   • Acceptance Criteria: Not explicitly stated as pass/fail thresholds for clinical performance. The "acceptance criteria" here implicitly refer to meeting the requirements for demonstrating substantial equivalence based on biomechanical testing as outlined in the relevant FDA guidance document.
   • Reported Device Performance: "Biomechanical testing results demonstrate the Columbus Knee System is substantially equivalent to other knee systems currently on the market." No specific performance metrics (e.g., range of motion, wear rates, failure rates) are provided.

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

   • No information on sample size for any test set or data provenance is provided. The testing described is biomechanical testing, which typically involves laboratory testing of device components or constructs, not human subjects, and thus does not have "data provenance" in the clinical sense.

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. The document describes biomechanical testing, not studies that require expert-established ground truth for a test set (e.g., image interpretation, disease diagnosis).

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

   • Not applicable. This refers to clinical study design for establishing ground truth, which is not present here.

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 MRMC or human reader study was conducted or mentioned. This device is a mechanical implant, not an AI diagnostic tool.

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

   • Not applicable. This device is a mechanical implant, not an algorithm. However, the biomechanical testing mentioned could be considered a "standalone" evaluation of the device's physical properties.

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

   • The "ground truth" for biomechanical testing typically relies on engineering standards, material properties, and comparison to the performance of predicate devices under standardized loading conditions. No clinical ground truth (expert consensus, pathology) is relevant here.

8. The sample size for the training set:

   • Not applicable. This device is a mechanical implant, not an AI algorithm that requires a training set.

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

   • Not applicable. No training set for an AI algorithm is involved.

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