(100 days)
The 3.0T GEM RT Open Array Coil, part of the Oncology Suite, is a receive-only RF coil designed for use with 3.0T MRI systems manufactured by GE. The indications for use include the head, neck, and brachial plexus and vasculature imaging. The nucleus excited is hydrogen.
The 3.0T GEM RT Open Array is a receive-only coil designed to provide optimal penetration, uniformity, and signal to noise ratio for the posterior head-neck and brachial plexus. The 3.0T GEM RT Open Array coil is an 8-Channel Phased Array, which is sold as an option to the Oncology Suite that is compatible with the 3.0T GE GEM compatible MR Scanner. The GEM RT Open Array is a posterior coil that comes with a Pconnector that can be plugged into the head end (P2) or foot end (P4) of the 3.0T GEM patient table (K103327). When used with the Oncology suite the GEM RT Open Array coil can be inserted into the GEM cradle at the head end.
This document describes the 510(k) premarket notification for the GE Healthcare 3.0T GEM RT Open Array coil, an RF coil designed for use with 3.0T MRI systems.
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1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance (Compliance) |
|---|---|
| AAMI/ANSI ES60601-1 (IEC 60601-1): Electrical Safety | Compliant with all applicable sections |
| IEC 60601-1-2: Electromagnetic Compatibility (e.g., electrostatic discharge) | Compliant with all applicable sections |
| IEC 60601-2-33: Electrical Safety | Compliant with all applicable sections |
| NEMA MS 6-2008: SNR and Uniformity of Phased Array Coils | Compliant with all applicable sections |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "The subject of this premarket submission, 3.0T GEM RT Open Array, did not require clinical studies to support substantial equivalence. Sample clinical images have been included in this submission."
Therefore, there isn't a "test set" in the traditional sense of a clinical study with a defined sample size for the device's performance in diagnosing conditions. The testing focused on technical compliance with electrical, EMC, and imaging quality standards. The sample clinical images mentioned are likely illustrative examples and not part of a formal performance evaluation with a statistical sample size. Data provenance is not specified beyond being "sample clinical images," likely from institutional data or internal testing, and it's retrospective as it's not a prospective clinical trial.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. As no clinical studies were required, there was no ground truth established by experts for a test set to assess diagnostic performance. The ground truth was based on engineering and physics principles for compliance with technical standards.
4. Adjudication Method for the Test Set
Not applicable. There was no clinical test set requiring expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No. An MRMC comparative effectiveness study was not done as clinical studies were not required to support substantial equivalence. The device is a receive-only RF coil, focusing on image acquisition quality rather than diagnostic interpretation by human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, in essence. The "performance" assessment was primarily standalone, focusing on the coiled device's physical and electronic characteristics (electrical safety, EMC, SNR, uniformity) through non-clinical laboratory testing. There is no "algorithm" in the typical sense of AI, but the device's inherent imaging capabilities were evaluated independently against established standards.
7. The Type of Ground Truth Used
The ground truth for this device's acceptance was based on compliance with established engineering and safety standards (AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-33, NEMA MS 6-2008). This is a technical ground truth, ensuring the device operates safely and produces images of expected quality based on physical parameters, rather than diagnostic outcomes or pathology.
8. The Sample Size for the Training Set
Not applicable. This device is a hardware component (an RF coil) and does not involve AI or machine learning algorithms that require a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this 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.