(174 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 software upgrade to the MRT-50GP/E2 (FLEXARTTM), MRT-50GP/H2 (FLEXARTTM/Hyper), MRT-150/F1 (VISARTTM), MRT-150/F2 (VISARTTM/Hyper)
Here's an analysis of the provided 510(k) summary relating to acceptance criteria and the study conducted:
Disclaimer: The provided document (K983110) is a 510(k) Premarket Notification summary from 1998 for a software upgrade to existing Magnetic Resonance Diagnostic Devices (FLEXART™ and VISART™). It focuses on demonstrating substantial equivalence to previously cleared devices. It primarily discusses safety parameters and imaging performance specifications rather than a typical clinical study with acceptance criteria for a new AI/CAD device.
This document predates widespread AI in medical imaging and the standard AI/CAD study structure. Therefore, many of the requested fields (like sample size for test/training sets, ground truth establishment methods, MRMC studies, effect sizes, and standalone performance) are not directly addressed in the provided text as they pertain to a different type of device evaluation.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of the document, the "acceptance criteria" are more akin to specifications that the software upgrade maintains, and the "reported device performance" indicates that these specifications are met or comparable to the predicate devices.
| Parameter/Criteria | Acceptance Criteria (V3.5 s/w) | Reported Device Performance (V4.0 s/w) | Outcome/Met? |
|---|---|---|---|
| Safety Parameters | |||
| Maximum static field strength (FLEXART™) | 0.5 T | 0.5 T | Met |
| Maximum static field strength (VISART™) | 1.5 T | 1.5 T | Met |
| Rate of change of magnetic field (FLEXART™) | 11 T/sec. | 11 T/sec. | Met |
| Rate of change of magnetic field (FLEXART™/Hyper) | 13.3 T/sec. | 13.3 T/sec. | Met |
| Rate of change of magnetic field (VISART™) | 13.3 T/sec. | 13.3 T/sec. | Met |
| Rate of change of magnetic field (VISART™/Hyper) | 19.5 T/sec. | 19.5 T/sec. | Met |
| Maximum RF power deposition (FLEXART™) |
§ 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.