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The Consensus® CoCr/Ti Femoral Component is intended for use with the Consensus® Knee System and is not intended for substitution of components from other systems. This device is intended for cemented use only. The indications for use are as follows:

• Primary intervention of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, or degenerative arthritis;
• Intervention of failed osteotomies and unicompartmental replacements;
• Replacement of unsatisfactory cemented or press fit knee components if sufficient bone stock exist.

The porous femoral knee component will be available in a left and right configuration and is designed to replicate the natural anatomy of the femur. The design of the femoral component incorporates a swept-back radius on the outer condyle surfaces to allow for smooth articulation throughout the range of motion. The outer articular surface of the femoral component will also have a deepened trochlear groove to allow for more anatomic tracking of the patellar component and improved range of motion. The material will be cast CoCrMo alloy (ASTM F75-92). The inner box geometry of the femoral component is designed to allow a minimum bone resection of 10mm distal, 9mm posterior, and 6.5mm anterior. The anterior flange of the femoral component is angled 4°outward, posterior to anterior, to reduce the potential for notching the anterior femur. The anterior flange will also incorporate a stepped chamfer which allows for positioning the trochlear groove in a more anatomic position. A smooth tapered peg will be located on each distal condyle to provide medial-lateral stability and enhanced fixation. The surfaces of the inner box geometry of the porous femoral component will incorporate a sintered porous coating of CoCr beads (ASTM F75-92), which will subsequently be coated with Titanium alloy (ASTM F67-95). The porous coating is designed to enhance cement fixation.

The provided document, a 510(k) Premarket Notification for the HAYES MEDICAL, INC Consensus® Knee System CoCr/Ti Femoral Component, focuses on establishing substantial equivalence to predicate devices. It does not contain information about a study proving the device meets specific acceptance criteria in the manner requested, i.e., a clinical study with detailed performance metrics and ground truth establishment for an AI/device.

Instead, the document describes the device's technical specifications and intended use, and argues that these are similar to existing devices already on the market. The FDA's letter (K983004) confirms this substantial equivalence, allowing the device to be marketed, with specific limitations regarding cemented use only.

Therefore, I cannot extract the requested information as it is not present in the provided text. The document is a regulatory submission for a medical device (a knee implant), not a study report for an AI or diagnostic device that would typically involve acceptance criteria, performance metrics, and human expert evaluation in the way described in your request.

If the request refers to the structural integrity and material properties of the knee implant, then the "acceptance criteria" and "study" would likely refer to engineering and biocompatibility tests (e.g., ASTM standards for materials, fatigue testing, etc.) which are not detailed in this public summary. The "Substantial Equivalence" section mentions that "The technological differences... have been thoroughly documented and tested in order to verify that no new issues of safety and effectiveness are raised by the design," implying such testing was done, but specifics are not provided.

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