(90 days)
Magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) of the brain, brain vasculature and other intracranial structures.
The GE Signa Contour 0.5 T MRI system operated with the Medical Advances Quadrature Brain Coil
This document describes a 510(k) submission (K982978) for the Medical Advances, Inc. Model 340GE-21C Quadrature Brain Coil, a device intended for use with GE Signa Contour 0.5 T MRI systems for diagnostic imaging of the brain and intracranial structures.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety Parameters | |
| Maximum Static Magnetic Field | No change compared to the legally marketed predicate device on the GE Signa Contour 0.5 T MRI system. |
| Rate of Magnetic Field Strength Change | No change compared to the legally marketed predicate device on the GE Signa Contour 0.5 T MRI system. |
| RF Power Deposition | No change compared to the legally marketed predicate device on the GE Signa Contour 0.5 T MRI system. |
| Acoustic Noise Levels | No change compared to the legally marketed predicate device on the GE Signa Contour 0.5 T MRI system. |
| Imaging Performance Parameters | |
| Specification Volume | No change compared to the legally marketed predicate device on the GE Signa Contour 0.5 T MRI system. |
| Signal-to-Noise Ratio | No change compared to the legally marketed predicate device on the GE Signa Contour 0.5 T MRI system. |
| Image Uniformity | No change compared to the legally marketed predicate device on the GE Signa Contour 0.5 T MRI system. |
| Geometric Distortion | No change compared to the legally marketed predicate device on the GE Signa Contour 0.5 T MRI system. |
| Slice Thickness and Gap | No change compared to the legally marketed predicate device on the GE Signa Contour 0.5 T MRI system. |
| High Contrast Spatial Resolution | No change compared to the legally marketed predicate device on the GE Signa Contour 0.5 T MRI system. |
2. Sample size used for the test set and the data provenance:
The provided document does not specify a separate "test set" in the context of a clinical performance study with human subjects or image data for the purpose of demonstrating performance against acceptance criteria. Instead, the submission relies on demonstrating substantial equivalence to a legally marketed predicate device. This is achieved by comparing the new device's technical specifications and safety parameters to those of the predicate device when used with the same MRI system. The data provenance would therefore be the engineering and physical measurements or specifications used to determine "no change" in these parameters. There is no indication of patient data or data origin (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This submission demonstrates substantial equivalence through technical specifications and safety parameters, not through a clinical evaluation involving expert interpretation of images or patient data to establish a "ground truth."
4. Adjudication method for the test set:
Not applicable. No clinical test set requiring adjudication is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is a passive component (MRI coil) and does not involve AI or human-in-the-loop performance improvement.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:
Not applicable. This device is an MRI coil, not an algorithm.
7. The type of ground truth used:
The "ground truth" in this context is the established performance and safety specifications of the legally marketed predicate device when used with the GE Signa Contour 0.5 T MRI system. The new device demonstrates substantial equivalence by showing "no change" in its performance and safety parameters compared to this established baseline.
8. The sample size for the training set:
Not applicable. This is not an AI/algorithm-based device requiring a training set.
9. How the ground truth for the training set was established:
Not applicable. This is not an AI/algorithm-based device requiring a training set.
§ 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.