(56 days)
The Discovery 3T 16 Ch Body Array Coil and Discovery 3T 32 Ch Body Array Coil are receive-only RF Coils designed for use with 3.0T MRI systems manufactured by GE Healthcare. The indications for use include chest, cardiac, abdomen, torso, pelvis, prostate, hips, and long bone imaging. The nucleus detected is hydrogen.
The Discovery 3T 16 Ch Body Array Coil and Discovery 3T 32 Ch Body Array Coil are surface coils used for Magnetic Resonance Imaging. They are tuned to image Proton nuclei in a receive-only configuration. They are comprised of 32 individual Phased Array coil elements each utilizing an integrated preamplifier to improve image quality. The geometry is optimized for use with parallel imaging techniques. The 16 Ch version uses multiplexers to allow a 32 channel design to be used on 16 Channel systems.
The GE Healthcare 510(k) Premarket Notification Submission (K103365) describes the Discovery 3T 16 Ch Body Array Coil and Discovery 3T 32 Ch Body Array Coil. The submission asserts that these devices are substantially equivalent to their predicate device, the USA Instruments Prima III TotalSENSE Torso Coil (K030371).
The study provided to demonstrate substantial equivalence and meet acceptance criteria is based on non-clinical voluntary standards, focusing on safety and performance, rather than clinical efficacy.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standards and Performance Metrics) | Reported Device Performance |
|---|---|
| Safety Standards: | Comply with all applicable sections. |
| IEC 60601-1: Electrical Safety | Comply with all applicable sections. |
| IEC 60601-1-2: Electromagnetic Compatibility (e.g., electrostatic discharge) | Comply with all applicable sections. |
| IEC 60601-2-33: Electrical Safety (e.g., documentation requirements) | Determinded to be post market acceptable. |
| ISO 10993-1: Biocompatibility (determination of post market acceptability of materials) | Improved upon the predicate device. |
| Performance Standards: | |
| SNR testing method identified in Section 18 | Increased channel and larger coverage area compared to the predicate. Shares similar high-level phased array, receive-only design. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly mention a specific "test set" in terms of patient data. The evaluation appears to be based on testing of the device hardware against engineering and safety standards. Therefore, information regarding "country of origin of the data" or "retrospective or prospective" is not applicable as it's not a clinical study involving patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The evaluation is against engineering standards rather than expert-derived ground truth on clinical images.
4. Adjudication Method for the Test Set
Not applicable. There is no mention of adjudication for a test set, as the study relies on compliance with technical standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission focuses on device equivalence based on technical specifications and safety standards, not on human reader performance with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance
Not applicable. This device is a receive-only RF coil for an MRI system, not an algorithm. Its performance is evaluated in terms of its ability to acquire high-quality MR signals.
7. Type of Ground Truth Used
The "ground truth" for this submission is established through compliance with recognized electrical, electromagnetic, and biocompatibility safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-33, ISO 10993-1), and performance characteristics like Signal-to-Noise Ratio (SNR) as per a specified method. This is a technical and engineering-based ground truth, not clinical ground truth derived from expert consensus, pathology, or outcomes data.
8. Sample Size for the Training Set
Not applicable. This is a hardware device (MRI coil), not an AI algorithm, so there is no training set in the AI sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of medical 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.