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The Columbus 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 is designed for use with bone cement.

The Ultra Congruent Tibial Insert is a gliding surface for the Columbus Total Knee System made from UHMWPE. The ultra congruent insert is designed with increased contact area that provides improved stability in flexion and extension. The Columbus UC gliding surfaces range in height from 10 mm to 20 mm and in size from T0/T0+ to T5

The provided text does not contain information about specific acceptance criteria, study methodologies, sample sizes, expert qualifications, or ground truth establishment relevant to the performance evaluation of the Columbus Total Knee System Ultra Congruent Tibial Insert.

Instead, the document is a 510(k) summary for a medical device. It describes:

• Company and Device Information: Manufacturer, contact, trade name, common name, classification, regulation number, and product code.
• Substantial Equivalence: The claim that the new device is substantially equivalent to previously cleared devices (predicate devices) based on similar design and materials.
• Device Description: A brief overview of the device, its material (UHMWPE), and its intended design features (increased contact area for improved stability).
• Indications for Use: The medical conditions and patient types for which the device is intended.
• Technological Characteristics: Comparison of the new insert with predicate devices, highlighting similarities in shape, size, material, and increased surface area.
• Performance Data (Planned): This section states what testing will be done or is applicable, rather than reporting actual results or acceptance criteria met. It lists "All required testing per 'Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices-The Basic Elements' will be done where applicable. In addition testing will be completed as applicable per the following:" followed by a list of relevant guidance documents for orthopedic implants and materials.
• FDA Correspondence: A letter from the FDA confirming the device's substantial equivalence to predicate devices and allowing it to be marketed, subject to general controls.

Key Takeaway:
The document describes the regulatory pathway and rationale for market clearance (510(k) process) for the Columbus Total Knee System Ultra Congruent Tibial Insert. It does not provide the detailed performance study results or acceptance criteria that would typically be found in a clinical trial report or a comprehensive performance data section. The "Performance Data" section merely outlines the types of guidance documents under which testing would be conducted, not the results themselves.

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