(8 days)
Magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) of the Musculoskeletal structures, soft tissue and vascular structures of the torso, pelvis, and abdomen.
Model 558GE-64 Torso Array Coil. Compatible with GE Signa EXCITE 1.5T MR Systems.
The provided text describes a 510(k) premarket notification for the "Model 558GE-64 Torso Array Coil" for Magnetic Resonance Diagnostic Devices. This submission focuses on establishing substantial equivalence to a predicate device, rather than performing a novel clinical study for the device itself. Therefore, many of the requested elements for a study proving device performance are not applicable or cannot be extracted from this document as it is a submission for a new coil for an existing MRI system, not a new diagnostic algorithm or AI device.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
For this device (an MRI coil), the "acceptance criteria" and "reported device performance" are framed in terms of maintaining the performance and safety characteristics of the MRI system when the new coil is used, and demonstrating equivalence to a predicate device.
| Acceptance Criteria (Stated Goal / Claim) | Reported Device Performance (as stated in the submission) |
|---|---|
| Safety Parameters: | |
| Maximum Static Magnetic Field: No change | No change due to coil |
| Rate of Magnetic Field Strength Change: No change | No change due to coil |
| RF Power Deposition: No change | No change |
| Acoustic Noise Levels: No change | No change due to coil |
| Biocompatibility: No change | No change |
| Imaging Performance Parameters: | |
| Specification Volume: No change | No change |
| Signal-to-Noise Ratio: No change | No change |
| 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 |
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a clinical study with a "test set" of patient data in the way an AI/diagnostic algorithm would. The evaluation seems to be based on technical specifications and comparison to a predicate device. Therefore, no information on sample size or data provenance in this context can be extracted.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. As this is not a diagnostic device with a "ground truth" to be established by experts on a test set, this information is not present.
4. Adjudication Method for the Test Set
Not applicable. There is no test set or adjudication method described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This document is for an MRI coil, not an AI-assisted diagnostic tool. No MRMC study or AI performance evaluation is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm, but a hardware component (MRI coil).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For a hardware component like an MRI coil, "ground truth" would relate to its physical and electromagnetic properties, not diagnostic accuracy in the clinical sense. The "ground truth" here is the established safety and performance of the MRI system with the new coil, which is shown by physical measurements and adherence to technical specifications, along with the substantial equivalence argument.
8. The sample size for the training set
Not applicable. There is no mention of a training set as this is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. No training set is involved.
Summary of the Study/Evidence Provided (for the MRI coil):
The submission for the "Model 558GE-64 Torso Array Coil" is a technical and substantial equivalence declaration, not a clinical efficacy study. The "study" implicitly referenced is the technical evaluation demonstrating that the new coil, when used with the GE Signa EXCITE 1.5T MR Systems, does not change the safety parameters (Maximum Static Magnetic Field, Rate of Magnetic Field Strength Change, RF Power Deposition, Acoustic Noise Levels, Biocompatibility) or the imaging performance parameters (Specification Volume, Signal-to-Noise Ratio, Image Uniformity, Geometric Distortion, Slice Thickness and Gap, High Contrast Spatial Resolution) compared to the MRI system without the new coil or compared to the predicate device.
The main "proof" is the argument of substantial equivalence to a legally marketed predicate device (Hitachi AIRIS-Elite 0.3T system operated with the identified predicate coil), based on:
- Same intended use.
- Similar technological characteristics (with the implication that the new coil maintains or does not degrade the established performance of the MR system it's compatible with).
- Demonstration that the coil does not affect the system's safety and imaging performance specifications.
The document states that a draft guidance document for MRDDs (issued Nov 14, 1998) clarifies concerns, and the submission summarizes information addressing these concerns, focusing on the lack of change in safety and performance parameters. The device also includes instructions for use, indications, precautions, cautions, contraindications, warnings, and quality assurance testing to assure safe and effective use.
§ 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.