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The NCB Plating System is indicated for temporary internal fixation of fractures and osteotomies of long bones.

The NCB Plating System is an extramedullary internal fixation plate system to be used for either distal femoral or proximal tibia fractures. It is intended to be implanted either percutaneously or by a traditional open method.

The provided text is a 510(k) summary for the Zimmer GmbH NCB® Plating System. This document describes a medical device, specifically a bone fixation system, and its premarket notification to the FDA.

Based on the content of the document, the device described is a mechanical implant, not an AI/software-based medical device. The "Performance Data (Nonclinical and/or Clinical)" section explicitly states:

• Non-Clinical Performance and Conclusions: "Class II: Amendment of Design Controls with verification of mechanical integrity and resistance."
• Clinical Performance and Conclusions: "Clinical data and conclusions were not needed for this device."

This means the clearance for this device was based on mechanical testing and verification of design controls, not on a study proving performance against acceptance criteria for an AI or software algorithm. There is no mention of an algorithm, AI assistance, human readers, or ground truth establishment in the context of device performance.

Therefore, I cannot provide the information requested in your prompt regarding acceptance criteria and study details for an AI/software device, as this document is about a physical orthopedic implant.

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