(78 days)
Imaging of:
- The Whole Body (including head, abdomen, breast, heart, pelvis, joints, neck, TMJ, . spine, blood vessels , limbs and extremities). [Application terms include MRCP (MR Cholangiopancreatography), MR Urography, MR Myelography, MR Fluoroscopy, SAS (Surface Anatomy Scan), Dynamic Scan, Cine Imaging, and Cardiac tagging.]
- . Fluid Visualization
- 2D/3D Imaging
- MR Angiography/MR Vascular Imaging
- Blood Oxygenation Level Dependent (BOLD) Imaging .
This submission consists of a new Magnetic Resonance Imaging system which is based primarily on the cleared VISART™/Hyper system (K965068) with modifications including a short bore magnet and gantry design. The software used with the EXCELART MRI system is V4 (K983110). All other technology used for the EXCELART system is the same as that of the cleared VISART™/Hyper system.
The provided text is a 510(k) Premarket Notification for the EXCELART Magnetic Resonance Diagnostic Device Accessory (MRI System). This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing independent clinical study results with detailed acceptance criteria and performance metrics for a new, non-inferiority claim.
Therefore, many of the requested details about acceptance criteria, specific study designs, sample sizes, and expert adjudications are not explicitly stated or applicable in the context of this 510(k) submission.
Here's an analysis of the provided information relative to your request:
1. A table of acceptance criteria and the reported device performance
The submission does not outline specific, quantitative acceptance criteria for image quality or diagnostic accuracy in the way a clinical study for a new AI device would. Instead, it demonstrates that the EXCELART system's safety and imaging performance parameters are comparable to its predicate device, the VISART™/Hyper system.
| Parameter | Acceptance Criteria (Predicate) | Reported Device Performance (EXCELART) |
|---|---|---|
| Safety Parameters | ||
| Maximum static field strength | 1.5T (VISART™/Hyper) | 1.5T |
| Rate of change of magnetic field | 19.5 T/sec. (VISART™/Hyper) | 19.35 T/sec. |
| Maximum radio frequency power |
§ 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.