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The Natural-Knee II Cemented Modular Tibial Baseplate is intended for cemented use only in total knee arthroplasty for treatment of the following conditions:

1. Patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.
2. Correctable valgus-varus deformity and moderate flexion contracture.
3. Those patients with failed previous surgery where pain, deformity or dysfunction persists.

The Natural-Knee II Cemented Tibial Baseplate is an asymmetrically oriented (e.g. both left and right orientations), nonporous component manufactured from cast CoCr alloy (ASTM F75).

The baseplate is designed to mate with all previously cleared tibial insert components of the Natural-Knee/Natural-Knee II System via capture features on the anterior rim and posterior plateau rims. As such, the baseplate incorporates the snap lock design from the previously cleared Natural-Knee II tibial baseplates. A slot has also been incorporated into the center of the base of the tray to allow for seating of the metal reinforcement pin of the previously cleared Natural-Knee II Constrained/Revision tibial inserts.

The cruciform stem portion of the baseplate is designed to accept one of the previously cleared stems used with the Natural-Knee II System (smooth straight, fluted straight, fluted offset). The baseplate stem boss incorporates the stem connection design of the previously cleared Natural-Knee II Revision Femoral Component. This connection design includes an inner female taper for primary attachment of the stem. Supplemental secondary stem fixation may be achieved by placing the stem attachment screw through the recessed hole in the baseplate and into the screw hole in the stem. The rounded, baseplate stem hole plug designed for use with this component may also be used if a stem is not desired. Unlike the stems, the plug does not possess a taper and is attached to the baseplate solely via the stem attachment screw previously described.

The inferior surface of the baseplate has cement pockets that are grit blasted to enhance cement fixation. The three fins of the stem boss aid in maintaining rotational stability.

I apologize, but this document does not contain the information required to answer your request. This document is a 510(k) summary for a medical device (a knee implant component). It describes the device, its intended use, and states that it is substantially equivalent to other legally marketed devices.

However, it does not include:

• Acceptance criteria for performance from a study.
• Results from a performance study detailing device performance metrics.
• Information about sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment because these types of studies are not typically part of a 510(k) submission for a mechanical implant deemed substantially equivalent based on design, materials, and intended use.

The 510(k) process for this type of device primarily focuses on demonstrating substantial equivalence to a predicate device, rather than requiring extensive clinical or AI performance studies with the specific metrics you've asked for.

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