(58 days)
The 3.0T 48CH Head Coil is a receive-only RF coil designed for use with select 3.0T MRI systems manufactured by GE Healthcare. The coil is indicated for use for head imaging. The nucleus excited is hydrogen.
The 48CH Head Coil is a phased-array receive-only coil designed to provide optimum signal-to noise, uniform coverage and high acceleration including multiband imaging of the head and brain. It is a 48-element coil tuned to image proton nuclei and designed for use with GE 3.0T MRI Systems. Each coil element has an integrated preamplifier to improve image quality and a custom MEMS (Micro Electro Mechanical System) switch to decouple the receive coil from the MR System body coil. The 48CH Head Coil has an anterior coil and a posterior coil with P-connectors. The coil has optimized pads to maximize patient comfort and image uniformity.
The provided document describes a 510(k) premarket notification for the GE Healthcare 48CH Head Coil. This document focuses on demonstrating substantial equivalence to a predicate device rather than detailing extensive clinical studies with specific acceptance criteria for diagnostic performance.
Therefore, the information you requested about acceptance criteria and how a study proves the device meets them, particularly regarding AI performance, human reader improvement, and ground truth establishment, is largely not present in this submission. This is typical for a device like an MRI coil, where the focus is on safety, technical performance (signal-to-noise ratio, uniformity, etc.), and demonstrating that it operates similarly to existing approved devices.
Here's a breakdown of what can be extracted from the document, and what is not available:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a formal table of clinical acceptance criteria for diagnostic imaging performance (e.g., sensitivity, specificity for detecting specific conditions). Instead, it focuses on non-clinical technical performance and safety.
| Acceptance Criteria (Non-Clinical) | Reported Device Performance (Summary) |
|---|---|
| Compliance with AAMI/ANSI ES60601-1 (Electrical safety) | Complies |
| Compliance with IEC 60601-1-2 (Electromagnetic compatibility) | Complies |
| Compliance with IEC 60601-2-33 (MRI specific safety) | Complies |
| Compliance with MS 6-2008 (Specific standard, likely internal GE) | Complies |
| Maximum B1 peak (Safety parameter) | Tested |
| Blocking Network Analysis (Technical performance) | Tested |
| Heat Testing (Safety parameter) | Tested |
| Biocompatibility (ISO 10993) | Successful track record, demonstrated by testing and history of use |
| Risk Analysis | Applied |
| Requirements Reviews | Applied |
| Design Reviews | Applied |
| Testing on unit level (Module verification) | Applied |
| Integration testing (System verification) | Applied |
| Performance testing (Verification) | Applied |
| Safety testing (Verification) | Applied |
| Simulated use testing (Validation) | Applied |
| Signal-to-noise ratio (Implied from description) | Designed to provide optimum signal-to-noise |
| Uniformity (Implied from description) | Designed for uniform coverage |
| High acceleration capability | Designed for high acceleration including multiband imaging |
| Decoupling of receive coil from MR System body coil | Achieved via custom MEMS switch |
2. Sample size used for the test set and the data provenance
- Test set for clinical performance: "The subject of this premarket submission, the 48CH Head Coil, did not require clinical studies to support substantial equivalence. Sample clinical images have been included in this submission." This indicates that there was no formal clinical test set for diagnostic performance as would be used for an AI device. The included "sample clinical images" are likely illustrative rather than for formal evaluation.
- Data provenance: Not applicable for a separate clinical test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no dedicated clinical test set with ground truth was required for this submission.
4. Adjudication method for the test set
Not applicable, as no dedicated clinical test set with ground truth was required for this submission.
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
No MRMC study was conducted or reported. This device is an MRI coil, not an AI-powered diagnostic tool.
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
Not applicable for clinical performance. For non-clinical tests, the ground truth would be based on engineering specifications, physical measurements, and compliance with established safety standards.
8. The sample size for the training set
Not applicable. This is a hardware device (MRI coil), not a software algorithm requiring a training set in the AI sense.
9. How the ground truth for the training set was established
Not applicable.
§ 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.