(63 days)
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"All required testing per 'Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices-The Basic Elements' were done where applicable.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.
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.