(14 days)
Imaging of:
- The Whole Body (including head, abdomen, pelvis, limbs and extremities, spine, neck, . TMJ, heart, blood vessels). {Application terms include MRCP (MR Cholangiopancreatography), MR Urography, MR Myelography, MR Fluoroscopy, SAS (Surface Anatomy Scan), Dynamic Scan and Cine Imaging.]
- Fluid Visualization .
- 2D / 3D Imaging ●
- MR Angiography / MR Vascular Imaging .
- . Water / Fat Imaging
- Perfusion / Diffusion Imaging .
The OPART™ /Ultra system is added into existing OAPRT™ series by incorporating the high performance gradient system. The OPART™ /Ultra system and the OPART™ system with Ultra gradient upgrade kit offers the modified sequences for the faster acquisition than existing OPART™ systems.
The provided text describes a 510(k) submission for a Magnetic Resonance Diagnostic Device Accessory, the OPART™/Ultra, and its upgrade kit. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a study report as would be found for a novel device. Therefore, much of the requested information, particularly regarding specific performance metrics, sample sizes for test/training sets, expert involvement, and ground truth establishment, is not present in the provided text.
However, I can extract and present the information that is available.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly present "acceptance criteria" in a quantitative format for imaging performance. Instead, it compares safety parameters of the new device (OPART™/Ultra) against its predicate (OPART™) and other substantially equivalent devices. The "performance" here refers to physical and operational characteristics rather than diagnostic accuracy.
| Parameter | OPART™ (Predicate, K993574) | OPART™/Ultra (Reported Performance) |
|---|---|---|
| Static field strength | 0.35 T | 0.35 T (Same) |
| Peak acoustic noise | 108 dB | 115.4 dB |
| A-weighted acoustic noise | 98.4 dB(A) | 102.5 dB(A) |
| Operational modes | Normal operating mode | Normal operating mode (Same) |
| Safety parameter display | SAR | SAR (Same) |
| Operating mode access requirements | Not applicable (only normal operating mode) | Not applicable (Same) |
| Maximum SAR |
§ 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.