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By providing in-suite scan control and viewing of MR images, the AIRIS II with the Interventional MR Package aids in the performance of minimally invasive, diagnostic, and therapeutic procedures of the head, body and extremities which may be facilitated by real-time MR guidance. Such procedures must be performed with MRI-compatible instrumentation, as selected and evaluated by the clinical user.

The MR system is an imaging device, and is intended to provide the plysician 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 II MRI Magnetic Resonance Diagnostic Device is being enhanced by optional hardware to aid in the performance of minimally invasive, diagnostic, and therapeutic procedures of the head, body, and extremities which may be facilitated by real-time MR guidance. Such procedures must be performed with MRI-compatible instrumentation, as selected and evaluated by the clinical user. Additional hardware includes QD Interventional Body Coil (IBC), in-suite image display and scanner control, physician kneelers, directed gantry illumination, and surgical drapes to provide a sterile field. The Latchable Joint/Large Extremity Coil, P/N MR-JCL-52, currently in commercial distribution supports imaging of the head and neck during interventional procedures of those anatomies.

AIRIS II software did not need to be revised in order to support full functionality of this additional hardware. MR Fluoroscopy was not made as an explicit marketing claim of the AIRIS II 510(k) K974212, however, the capabilities were available at the time of the submission (Cf. K974212, Attachment F, Functional Specification, 2D/3D SG and 2D/3D SG (RSSG) images acquisition sequences).

The provided text is a 510(k) summary for the Hitachi AIRIS II Interventional MR Package. It primarily focuses on demonstrating substantial equivalence to a predicate device and describing the technical characteristics and intended use of the MR system.

Crucially, this document does not contain any information about a performance study, acceptance criteria, or specific performance metrics for the device.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, study details, sample sizes, expert qualifications, or ground truth methods from the provided text.

The document states:

• "Identical to the AIRIS II 510(k) K974212." for device function.
• "Identical to the Predicate Device." for technological characteristics.
• The FDA letter confirms substantial equivalence based on the indications for use.

This implies that the device is considered equivalent to existing, legally marketed devices, and no new performance study data with specific acceptance criteria is presented in this summary for the "Interventional MR Package". The primary purpose of this 510(k) appears to be to introduce optional hardware that enhances the capabilities of an already-cleared MRI system, rather than to demonstrate novel performance characteristics requiring a new, detailed clinical performance study.

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