(90 days)
Magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) of the musculoskeletal structures, soft tissue and vascular structures of the lower extremities.
Model 472GE-128 Quadrature Lower Extremity Coil. Compatible with GE Signa 3.0T MR Systems. Magnetic Resonance Imaging Coil.
This document describes a 510(k) premarket notification for a magnetic resonance imaging (MRI) coil, not an AI/ML device. Therefore, the specific criteria related to AI/ML device performance, such as sample sizes for test and training sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment for AI models, are not applicable to this submission.
The acceptance criteria and study information provided in this document pertain to the substantial equivalence of the new MRI coil to a legally marketed predicate device, focusing on safety and imaging performance parameters relevant to MRI coils.
Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are demonstrated by its substantial equivalence to a predicate device, specifically the GE Signa 1.5T MR system with its legally marketed lower extremity coil. The new device, the Model 472GE-128 Quadrature Lower Extremity Coil, is intended for use with the GE Signa 3.0T MR system. The parameters assessed for substantial equivalence fall into categories of safety and imaging performance.
Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Substantial Equivalence) | Reported Device Performance (vs. Predicate Device) |
|---|---|---|
| Safety Parameters | ||
| Maximum Static Magnetic Field | No change due to coil | No change due to coil |
| Rate of Magnetic Field Strength Change | No change due to coil | No change due to coil |
| RF Power Deposition | No change | No change |
| Acoustic Noise Levels | No change due to coil | No change due to coil |
| Biocompatibility | No change | No change |
| Imaging Performance Parameters | ||
| Specification Volume | No change | No change |
| Signal-to-Noise Ratio (SNR) | Acceptable (improved over predicate) | 2 Times Improvement over Predicate Device |
| Image Uniformity | No change | No change |
| Geometric Distortion | No change | No change |
| Slice Thickness and Gap | No change | No change |
| High Contrast Spatial Resolution | No change | No change |
Study Proving Device Meets Acceptance Criteria
The study demonstrating that the device meets the acceptance criteria is a substantial equivalence evaluation rather than a traditional clinical trial or AI model validation study. The manufacturer, IGC-Medical Advances Inc., performed an analysis and comparison against a legally marketed predicate device (a GE Signa 1.5T system with a comparable lower extremity coil).
The provided text details this comparison: "The GE Signa 3.0T MRI system, operated with the Medical Advances Quadrature Lower Extremity Coil, is substantially equivalent to the GE Signa 1.5T system operated with the legally marketed predicate device listed in section 4.0, within the Class II definition of Magnetic Resonance Diagnostic Device with respect to the safety parameter action levels" and "The GE Signa 3.0T MRI system operated with the Medical Advances Quadrature Lower Extremity Coil addressed in this PMN, has the same intended use and technological characteristics as the GE Signa 1.5T system operated with the identified legally marketed predicate device. The use of this coil does not affect the GE Signa 3.0T system safety parameter specifications."
This evaluation focuses on demonstrating that the new coil, when used with its specified MRI system, maintains the safety parameters and either maintains or improves upon the imaging performance characteristics of the predicate device. The specific improvement noted is a "2 Times Improvement over Predicate Device" in Signal-to-Noise Ratio. Other parameters are stated to have "No change," indicating they meet the equivalence standard by not degrading performance.
Information Not Applicable to This Submission:
As this is a 510(k) for an MRI coil and not an AI/ML device, the following points are not relevant and therefore not addressed in the provided document:
- Sample size used for the test set and the data provenance: Not an AI/ML device.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not an AI/ML device.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not an AI/ML device.
- 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 an AI/ML device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not an AI/ML device. This relates to the performance of the physical hardware (coil) in conjunction with an MRI system.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not an AI/ML device. Performance is typically assessed through phantom studies, engineering measurements, and potentially comparison of image quality in human subjects or cadavers, but not for "ground truth" as understood in AI/ML.
- The sample size for the training set: Not an AI/ML device.
- How the ground truth for the training set was established: Not an AI/ML device.
§ 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.