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The LEONI Orion System in an electro-mechanical robotic arm for patient positioning in radiotherapy and medical imaging. It is designed for positioning a patient with a high degree of accuracy and repeatability.

The LEONI ORION System is an electro-mechanical robotic arm capable of motion in six degrees of freedom. The purpose of the device is to position a patient during radiotherapy, radiology and other medical applications with a high degree of accuracy and repeatability.
The LEONI ORION System consists of the electro-mechanical unit that is a 6 axes robot which supports a standard radiotherapy table couch or other approved patient support device, and a Control Unit that includes computers and application software. The robot is linked to the Control Unit by cables.

The provided text is a 510(k) summary for the LEONI ORION System, an electro-mechanical robotic arm for patient positioning in radiotherapy and medical imaging. It focuses on demonstrating substantial equivalence to a predicate device, rather than a clinical study evaluating diagnostic performance. Therefore, many of the requested items related to AI device evaluation (like MRMC studies, ground truth establishment for training data, and expert qualifications) are not applicable or cannot be extracted from this document.

Here's an analysis based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

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