Search Results

The Columbus Revision 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 Revision Knee System is designed to for use with bone cement.

The cemented Columbus Revision Knee System is a fixed prosthesis system that is available with one femoral design, the Posterior Stabilizing (PS) which offers stabilization it the ligament (PCL) is absent, weakened, or sacrificed during implantation. The system is manufactured from CoCrMo with the exception of the tibial "gliding surfaces" which are manufactured from UHMWPE. The complete system (femoral and tibial) makes up of numerous component available in various sizes. All components are sterile and for single use only.

This document is a 510(k) summary for the Columbus REVISION Knee System, a medical device. It does not contain information about acceptance criteria or a study proving that the device meets those criteria. Instead, it focuses on demonstrating substantial equivalence to previously cleared devices.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based on the provided text.

The "PERFORMANCE DATA" section (page 1, section 2) mentions:

• "All required testing per 'Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices-The Basic Elements' were done where applicable."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 for the Preparation of Premarket Notifications (510(k)s) for Cemented, Semi-Constrained Total Knee Prostheses', and 'Class II Special Controls Guidance Document for Knee Joint Patellofemorotibial & . Femorotibial Metal/Polyer Porous-Coated Uncemented Prostheses: Guidance for Industry and FDA.'"

These statements indicate that specific guidance documents were followed for performance testing, but they do not provide the detailed acceptance criteria or the results of the studies themselves. To get that information, one would need to refer to the full 510(k) submission, which is not included in this extract.

Ask a specific question about this device

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.

Ask a specific question about this device