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The Intai Anatomy Locking Plate and Screw System is provided non-sterile. The system is intended for use in fixation of fractures to the various bones, including; clavicle, radius, ulna, humerus, femur, tibia, fibula, and acetabulum for adults. This system is not indicated for use in the spine.

The Intai Anatomical Locking Plate and Screw System offers anatomically contoured plates for use with non-locking and locking screws. The plates are provided with locking holes as well as holes for cortex screws to enhance compression pressure. With the combination of locking and compression technology, the system further ensures the stability of the implant devices.

The provided text is a 510(k) Premarket Notification for the "Intai Anatomical Locking Plate and Screw System." This document is a regulatory submission for a medical device and does not describe:

• Acceptance criteria for an AI/ML powered medical device. The device is a physical bone fixation system.
• A study involving a test set, ground truth, experts, or AI/ML performance. The performance data discussed relates to biomechanical testing of the physical plates and screws (e.g., bend, fatigue, torque, pullout testing) against ASTM standards, not a clinical or AI-driven performance study.
• Training sets or adjudication methods for AI/ML models.

Therefore, I cannot extract the requested information regarding AI/ML device performance, ground truth, expert adjudication, or MRMC studies from the provided text. The document focuses on demonstrating substantial equivalence of a bone fixation system to existing predicate devices based on its intended use, materials, design features, and biomechanical non-clinical tests.

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