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The MR Instruments TEM 3002G-HN Dual Tune headcoil is to be used in conjunction with a 3T Magnetic Resonance Imaging system to produce proton ('H) images and spectra of the internal structures of the head. In addition, sodium (20Na) images and spectra may be obtained during the same exam without changing the coil. These images and/or spectral information of the head, when interpreted by a trained physician, may yield information that may assist in diagnosis. This device is for prescription use.

The TEM 3002G-HN Dual Tune headcoil is a quadrature transmit/receive RF coil tuned to proton ('H) and sodium (22Na) frequencies 3T. The TEM resonant elements and associated matching and quadrature splitting circuitry are enclosed in a rigid plastic housing to prevent any exposure to patient or environment.

The provided text describes the TEM 3002G-HN Dual Tune Headcoil, which is a medical device for Magnetic Resonance Imaging (MRI). However, it is a 510(k) summary for a physical medical device (an MRI headcoil), not an AI/ML powered device. As such, it does not include information on acceptance criteria, a study proving the device meets acceptance criteria, sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth, or training set sample sizes, which are all typically associated with the evaluation of AI/ML diagnostic tools.

Therefore, the prompt cannot be answered with the provided text because it describes a hardware device, not an AI/ML powered diagnostic tool.

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