(87 days)
Imaging of the whole body (including the head, abdomen, heart, pelvis, spine, blood vessels, limbs and extremities), fluid visualization, 2D/3D Imaging, MR Angiography, MR. Fluoroscopy
The VISART™ consists of two model upgrades to the MRT-150A system which provide increased gradient field strength, more ergonomic computer architecture, improved scan parameter specifications and a lighter magnet than the MRT-150A.
This is a pre-amendment 510(k) submission for the VISART™ Magnetic Resonance Device, MRT-150A/H1 and MRT-150A/F1 models. The submission primarily focuses on demonstrating substantial equivalence to an existing device (MRT-150A) by highlighting hardware and software upgrades that improve performance without introducing new safety or effectiveness questions. The provided text, however, does not contain details about a specific study testing device performance against defined acceptance criteria in the manner typically seen for algorithmic or AI-based devices.
The submission describes general increases in imaging performance parameters and safety parameters compared to the predicate device. It also mentions that "Sample phantom images and clinical images were presented for all new sequences demonstrating conformance with consensus standards requirements for Signal-to-Noise ratio Uniformity, Slice Profiles, Geometric Distortion and Slice Thickness/Interslice Spacing." This indicates that some form of evaluation was performed, but the specifics of a structured study with statistical outcomes are not detailed.
Given the information provided, I cannot fully answer your request in the format you've outlined for an AI/algorithm-driven device's acceptance criteria and study. However, I can extract the relevant information as much as possible based on the provided text.
Here's an attempt to address your request based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" for the upgraded models in a quantitative, pass/fail manner. Instead, it highlights improvements over the predicate device (MRT-150A) and states conformance with "consensus standards requirements."
| Parameter | Acceptance Criteria (Implied / Stated Conformance) | Reported Device Performance (MRT-150A/H1 & MRT-150A/F1) |
|---|---|---|
| Safety Parameters | ||
| Max. Static Field Strength | Not explicitly stated, but "Same" as predicate (1.5T) is presented as acceptable. | 1.5T (Same as MRT-150A) |
| Rate of Change of Magnetic Field ($\tau$=1000ms) | Not explicitly stated, but an improved rate is presented as acceptable and less than IEC standard. | 13.3 T/sec. (Improved from 7.5 T/sec. of MRT-150A) |
| Max. Radio Frequency Power Deposition | Not explicitly stated, but an improved/reduced value is presented as acceptable. |
§ 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.