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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 Magnetic Resonance Diagnostic Device is being enhanced by the STRATIS II System-level upgrade to increase the clinical utility of the STRATIS in the stationary configuration. The STRATIS II is provided in a stand-alone configuration, and as an upgrade path to existing STRATIS installations. STRATIS II System-level upgrade enhancements include a new Back End user interface featuring a workstation-based User Console, implementing a graphical user interface operating system and task card-style operations (OpenWindows™). A new Front End provides real-time system control, data acquisition and reconstruction, implements all image acquisition sequences available on current STRATIS, and provides two additional types of image acquisition sequences: TRSG (time-reversed steady-state acquisition with rewinded gradient echo) and RSSG (rf spoiled steady-state acquisition with rewinded gradient echo). Other enhancements include an elliptical T/R QD Body Coil, a patient physiological gating package, and phased-array RF coils.

This document describes the Hitachi STRATIS II Magnetic Resonance Diagnostic Device, but it does not contain any information regarding acceptance criteria, performance studies, or ground truth establishment.

The provided text is a 510(k) premarket notification for an MRI system, indicating that the device is being enhanced to increase clinical utility. It details the device's function, scientific concepts of MRI, physical and performance characteristics, and intended use. The key aspect of the submission is that the device's technological characteristics are "Identical to the Predicate Device" (Hitachi STRATIS with Version 6-05 Operating System Software).

Therefore, I cannot provide the requested information. The document focuses on demonstrating substantial equivalence to a predicate device, which typically relies on showing that the new device has the same technological characteristics and intended use as a device already cleared by the FDA, rather than presenting new performance studies against specific acceptance criteria.

To answer your request for acceptance criteria and study details, this information would need to be present in a different type of regulatory submission or an accompanying technical report.

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