(137 days)
The 1.5T 8ch Flex Suite manufactured by Shenzhen RF Tech Co., Ltd is receive-only coil and is designed for use as general purpose coil. The 1.5T 8ch Flex Suite is designed to be use with GE 1.5T MRI systems to produce diagnostic images of upper and lower extremities, head and spine that can be interpreted by a trained physician.
The 1.5T 8ch Flex Suite is receive-only phased array coil for imaging the upper and lower extremities, head and spine in adult population. The 1.5T 8ch Flex Suite consists of three flexible and lightweight coil of different size that can be wrapped or orientated flat, in order to accommodate various anatomic shapes and sizes.
The 1.5T 8ch Flex Suite is tuned to receive RF frequency corresponding to the proton precession in a 1.5 Tesla magnetic field, which is governed by the Larmor equation.
The 1.5T 8ch Flex Suite is flexible and can be wrapped around the anatomy of interest, which is similar to its predicate device.
The 1.5T 8ch Flex Suite is general purpose receive only coil with 8 elements and intergraded preamplifiers.
The 1.5T 8ch Flex Suite is based on phased array technique for combining the images from 8 different channels. The 1.5T 8ch Flex Suite is tuned to the proton frequency of 63.86MHz.
Here's a breakdown of the acceptance criteria and study information for the 8ch Flex Suite, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes a receive-only MRI coil, not an AI-powered diagnostic device. Therefore, the "acceptance criteria" discussed are primarily related to the coil's physical, electrical, and imaging performance, ensuring it functions safely and effectively as an MRI accessory. The document doesn't present a standard table of "acceptance criteria" for diagnostic accuracy common in AI/standalone device submissions (e.g., sensitivity, specificity, AUC).
Instead, the submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical and limited clinical testing. The "performance" is implicitly tied to meeting the standards and showing comparable image quality to the predicate.
| Acceptance Criteria / Test Category | Reported Device Performance (Summary) |
|---|---|
| Non-Clinical Tests | |
| Biocompatibility testing | Performed (documented in submission) |
| IEC 60601-1-2 testing (EMC) | Performed (documented in submission) |
| IEC 60601-1 testing (Safety) | Performed (documented in submission) |
| Maximum B1 Peak test | Performed (documented in submission) |
| Signal to Noise ratio & uniformity | Performed according to NEMA standard (documented in submission) |
| Blocking Network analysis | Performed (documented in submission) |
| Surface temperature test (normal) | Performed (documented in submission) |
| Surface temperature test (unplugged) | Performed (documented in submission) |
| Clinical Tests (Image Quality) | |
| Image quality for anatomies (upper/lower extremities, head, spine) | Analyses in axial, sagittal, and coronal planes run to show substantial equivalence with predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify a numerical sample size for the clinical test set (i.e., how many patients/scans were used). It only states that "Analyses in axial, sagittal and coronal planes were run on the 8ch Flex Suite."
- Data Provenance: Not specified. The document does not mention the country of origin of the data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The "clinical tests" described are for evaluating image quality for substantial equivalence, not typically for establishing a diagnostic ground truth against a specific disease. The interpretation is stated to be by a "trained physician" for the intended use, but the number or qualifications of experts for the comparative study are not detailed.
4. Adjudication Method for the Test Set
This information is not provided in the document. Given the nature of the "clinical tests" described (comparing image quality for substantial equivalence), a formal adjudication method for diagnostic ground truth might not have been central to this type of submission.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. The document describes clinical tests to demonstrate substantial equivalence of image quality between the 8ch Flex Suite and a predicate device. It does not involve human readers interpreting images with and without AI assistance, nor does it address an effect size of AI on human reader performance. This device is an MRI coil, not an AI diagnostic tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study
- Not applicable. The 8ch Flex Suite is an MRI coil, a hardware component for image acquisition, not an algorithm or AI software that performs standalone diagnostic functions.
7. Type of Ground Truth Used
- For the "clinical tests" described, the implicit ground truth is comparable image quality sufficient for diagnostic interpretation by a trained physician when compared against the predicate device. It's not about definitive diagnosis of a specific pathology through expert consensus, pathology, or outcomes data in the way an AI diagnostic algorithm would be evaluated. The aim is to show the coils produce diagnostically acceptable images.
8. Sample Size for the Training Set
- Not applicable. This device is an MRI coil and does not involve AI or algorithms that require a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As stated above, there is no training set for an MRI coil.
§ 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.