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The Columbus (CR) Total Knee System 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 (CR)Total Knee System additions include a CRA/PSA tibial tray and hemispacers, commonly known as wedges. The CRA/PSA tibial tray and wedges can be used with the existing femoral component, insert, patella and attachment mechanism of the Columbus (CR) Total Knee System cleared via K022672 or with the femoral component and insert of the Columbus (PS) Total Knee System cleared via K030367. The CRA/PSA tibial tray and wedges are manufactured from CoCrMo.

The provided document is a 510(k) summary for the Columbus (CR) Total Knee System. This type of regulatory submission is for medical devices that are substantially equivalent to a predicate device already on the market. It does not contain information about clinical studies with acceptance criteria or performance metrics in the way you've described for an AI/software device.

Instead, the document focuses on:

• Substantial Equivalence: Comparing the new device (Columbus (CR) Total Knee System additions) to existing legally marketed devices (predicates) based on technological characteristics (materials, shapes, sizes).
• Performance Data: This section refers to non-clinical testing, specifically mechanical and materials testing, to ensure that the device meets established standards for orthopedic implants. It does not involve patient data, expert interpretations, or AI algorithm performance.

Therefore, I cannot extract the information required by your request (acceptance criteria, device performance table, sample size, ground truth, experts, adjudication, MRMC, standalone) because this type of information is not relevant to a 510(k) submission for a mechanical orthopedic implant.

The document states:
"All required testing per 'Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices-The Basic Elements' were done where applicable. In addition, testing per the

• 'Guidance Document for Testing Orthopedic Implants with Modified Metallic . Surfaces Apposing Bone or Bone Cement',
• 'Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on . Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements'
• 'Guidance Document for Testing Non-articulating, "Mechanically Locked" Modular . Implant Components', and
• 'Data Requirements for Ultrahigh Molecular Weight Polyethylene (UHMPE) Used . in Orthopedic Devices' was completed where applicable."

This indicates that the performance data involved fulfilling specific mechanical and material testing standards outlined in FDA guidance documents for orthopedic implants, not clinical studies with human readers or AI algorithms.

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The Columbus (CR) Total Knee System is intended 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 persists, and for patients suffering from correctable valgus or varus deformity and moderate flexion contracture.

The Columbus Knee is designed for use with bone cement.

The cemented Columbus (CR) Total Knee System 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. In addition to the standard insert design, a "deep dish" design is available for patients that may need more stability than the standard design. The "deep dish" insert has a slightly smaller range of motion to provide more restraint than the standard insert design. The gliding surfaces (inserts) and patellas are manufactured from UHMWPE.

The provided text describes the Columbus (CR) Total Knee System, a medical device. However, it does not contain information about a study that assesses device performance against specific acceptance criteria in the context of an AI/human reader comparative effectiveness study, or a standalone algorithm study.

Instead, the document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to predicate devices already on the market.

Here's a breakdown of what the document does state regarding performance, and then an explanation of why the requested information cannot be extracted:

Performance Information Present in the Document:

• Acceptance Criteria and Reported Device Performance: This document 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 that the Columbus (CR) Total Knee System is substantially equivalent to other knee systems currently on the market."
  • Acceptance Criteria (Implied): The acceptance criteria are implicitly tied to meeting the requirements of the "Draft Guidance for the Preparation of Premarket Notifications (510(k)s) for Cemented, Semi-Constrained Total Knee Prostheses." These guidances typically stipulate a range of mechanical and material tests (e.g., fatigue, wear, strength, corrosion) and their associated pass/fail thresholds, ensuring the new device performs at least as safely and effectively as predicate devices. The specific numerical criteria are not detailed in this summary.
  • Reported Device Performance: The reported performance is that the device demonstrated substantial equivalence to predicate devices based on biomechanical testing. No specific numerical results (e.g., wear rates, fatigue cycles survived) are provided in this summary.

Why the Requested Information (Related to AI/Human Reader Studies) Cannot Be Provided from this Document:

The Columbus (CR) Total Knee System is a physical orthopedic implant. The requested information (sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, ground truth types for training sets, and training set sizes) is typically relevant for software as a medical device (SaMD) or AI-powered diagnostic/interpretive systems.

This 510(k) document is for a physical medical device and therefore does not include:

1. A table of acceptance criteria and the reported device performance: While generic "biomechanical testing results" are mentioned, no specific criteria or performance metrics are provided in a table format that would be applicable to an AI study.
2. Sample size used for the test set and the data provenance: Not applicable to a physical implant's premarket submission for substantial equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
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. MRMC studies are for evaluating diagnostic accuracy, particularly with AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is for AI algorithms.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. "Ground truth" in this context would implicitly be compliance with engineering standards and material properties, not diagnostic classifications.
8. The sample size for the training set: Not applicable. There is no AI model to train.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document describes a premarket submission for a physical knee implant and uses "substantial equivalence" as its primary regulatory pathway, relying on compliance with established engineering standards rather than clinical performance studies involving diagnostic accuracy or AI algorithms.

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