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The Ortho Development Balanced Knee™ Modular Tibial System is indicated for patients suffering from severe knee pain and disability. Specific indications include femoral, tibial and patellar replacement due to degenerative bone disease such as rheumatoid arthritis or osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyles, pseudo-gout, or complications from a previous prosthesis. This device is intended for cemented use only.

The Balanced Knee™ Tibial Tray Pegged is intended for single use in primary total knee replacement only. Indications include:

• Loss of joint configuration and joint function;
• Osteoarthritis of the knee joint;
• Rheumatoid arthritis of the knee joint;
• Post-traumatic arthritis of the knee joint;
• Moderate valgus, varus, or flexion deformities;
• Revision procedures where other treatments or devices have failed.

The Ortho Development Balanced Knee™ Modular Tibial System is a semi-constrained total knee replacement system, consisting of tibial components, stem extensions and tibial augments. The devices are manufactured from Ti-6Al-4V alloy per ASTM standards.

The provided text is a 510(k) summary for the Ortho Development Balanced Knee™ Modular Tibial System. This document outlines the device's description, intended use, and comparison to predicate devices for substantial equivalence. It does not contain information about acceptance criteria, device performance from a study, sample sizes, expert involvement, adjudication methods, or ground truth establishment that would typically be found in a study report for an AI/ML device.

The 510(k) process for this device, a knee replacement system, focuses on demonstrating substantial equivalence to already legally marketed devices, primarily by comparing design, function, materials, and intended use. It does not involve performance studies in the same way an AI/ML diagnostic or predictive device would.

Therefore, I cannot provide the requested table and study details. The document explicitly states:

• "There are no significant differences between the Ortho Development Balanced Knee™ Modular Tibial System and the systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to these other devices in design, function, material and intended use." (K031201, page 1)

This statement is the core of a traditional medical device's 510(k) submission and explains why the detailed study information relevant to AI/ML device performance is not present.

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