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This device is indicated to acquire and display cross sectional volumes of the whole body, to include the head. The Aquilion Serve has the capability to provide volume sets can be used to perform specialized studies, using indicated software/hardware, by a trained and qualified physician. AiCE (Advanced Intelligent Clear-IQ Engine) is a noise reduction algorithm that improves image quality and reduces image noise by employing Deep Convolutional Neural Network methods for abdomen, pelvis, lung, cardiac, extremities, head and inner ear applications.

Aquilion Serve (TSX-307A/1) V1.3 is a whole body multi-slice helical CT scanner, consisting of a gantry, couch and a console used for data processing and display. This device captures cross sectional volume data sets used to perform specialized studies, using indicated software, by a trained and qualified physician. This system is based upon the technology and materials of previously marketed Canon CT systems.

The provided text is a 510(k) summary for the Aquilion Serve (TSX-307A/1) V1.3, a Computed Tomography X-ray System. It details the device, its intended use, and substantial equivalence to a predicate device. However, it does not include specific acceptance criteria or details of a study that proves the device meets those criteria in the format requested.

The document primarily focuses on explaining modifications from a prior version of the device (V1.2 with AiCE-i) and comparing technological characteristics. It mentions "Performance Testing - Bench" for SilverBeam Image Quality Evaluation and SilverBeam Dose Reduction, and "Workflow Evaluation," but these are described as general assessments rather than detailed studies with quantitative acceptance criteria and results. Furthermore, there is no mention of an MRMC study, expert ground truth establishment with multiple readers, or detailed sample sizes for training/test sets as typically required for AI/algorithm performance studies in the context of device clearance.

Therefore, I cannot provide the requested information from the given text. The information outlined in your request (specifically points 1-9 regarding acceptance criteria, study design, expert involvement, and ground truth) is not present in this 510(k) summary. This document primarily focuses on hardware and software feature additions (Dynamic scan mode, Exposure reduction mode, Dual Energy scanning, Extended field of view) and their safety and equivalence to an existing cleared device, rather than detailed performance metrics of an AI algorithm like AiCE that would be evaluated with clinical accuracy studies.

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