(91 days)
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 AIRIS Magnetic Resonance Diagnostic Device is being enhanced by the AIRIS II System-level upgrade to increase the clinical utility of the AIRIS in the stationary configuration. The AIRIS II is provided in a stand-alone configuration, and as an upgrade path to existing AIRIS installations.
AIRIS 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 AIRIS, 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 increased gradient strength, a patient physiological gating package, and phased-array RF coils.
This document is a 510(k) summary for the AIRIS II, a Magnetic Resonance Diagnostic Device. It claims substantial equivalence to the Hitachi AIRIS with Version 4.0 Operating System Software. The document describes the device's function, scientific concepts, physical and performance characteristics, intended use, and technological characteristics.
There is no information provided in the given text regarding acceptance criteria, a study proving device conformance, reported device performance, sample sizes, data provenance, ground truth establishment, expert involvement, adjudication methods, or MRMC studies.
The document states that the DEVICE TECHNOLOGICAL CHARACTERISTICS are "Identical to the Predicate Device." This implies that the current submission relies on the predicate device's existing substantial equivalence for its technological characteristics, rather than presenting a new study for the AIRIS II's performance.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details based on the provided text. The document is primarily focused on describing the enhancements of the AIRIS II over the AIRIS, its intended use, and its equivalence to a predicate device for regulatory purposes.
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.