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The MR system is an imaging device, and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The MR system produces transverse, coronal, sagittal, oblique, and curved cross-sectional images that display the internal structure of the head, body, or extremities. The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2), and flow. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination.

The STRATIS / MRH-1500 Operating System Software is revised to Version 6 to increase the clinical utility of the STRATIS / MRH-1500 in the stationary configuration.

Version 6 Operating System revisions include the addition of RF spoiling, SSP for enhanced 3D MRA, RF Fat Suppression, MTC for background suppression, 3D-FSE, 3D-FIR, rephase added to 2D-FSE and 2D-GFF, 2D-FIR Dual Contrast, RF coil uniformity image post-processing, and adaptive image post-processing.

I am sorry, but the provided text does not contain the necessary information to answer your request regarding acceptance criteria and a study proving device performance. The text describes a 510(k) summary for a Magnetic Resonance Diagnostic Device (Version 6 Operating System Software) and focuses on the device's function, scientific concepts, physical/performance characteristics, and intended use as compared to a predicate device.

Specifically, the following information is missing from the provided document:

• Acceptance criteria and reported device performance: No specific performance metrics, thresholds, or results are mentioned.
• Study details: There is no description of any clinical or technical study, including sample sizes, data provenance, ground truth establishment, expert involvement, or adjudication methods.
• MRMC comparative effectiveness study: No such study is mentioned or details provided.
• Standalone algorithm performance: No standalone performance data is presented.
• Ground truth type: Not specified for any hypothetical study.
• Training set size and ground truth establishment: Not mentioned.

Therefore, I cannot generate the table or the detailed description of the study as requested.

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