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The Millennium III 3T 8-Channel Neurovascular Coil is designed to provide magnetic Resonance Images of the brain, cervical spine, soft tissues and vasculature of the head, neck, and upper chest. The Millennium III 3T 8-Channel Neurovascular Coil is designed for use with the GE 3.0T scanner manufactured by GE Medical Systems, Inc.

The indications for use are the same as for standard imaging:

The 3.0T MRI system is indicated for use as an NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR signal, (2) depend upon parameters (proton density, spin lattice relaxation time T1, and spin spin relaxation time T2) and (3) display the soft tissue structure of the body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.

The Millennium III 3T 8-Channel Neurovascular Coil is a multi-element phased array receive-only coil. The coil is shaped to conform to the contours of the head and spine and has been designed to maximize comfort and ease of use. The elements and associated circuitry are enclosed in a housing made of plastic materials, which are fire rated and have high impact and tensile strength.

The provided document is a 510(k) premarket notification for a medical device (Millennium III 3T 8-Channel Neurovascular Coil). It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML medical device.

This document describes a new MRI accessory and demonstrates its substantial equivalence to previously cleared predicate devices. The focus is on comparing the physical characteristics, intended use, indications for use, and safety features (like RF burn prevention and RF absorption) of the new coil to existing, cleared coils.

Therefore, I cannot provide the requested information. The document is not a study report for an AI/ML device that would establish performance metrics against acceptance criteria.

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