(115 days)
To be used in conjunction with a GE 1.5 HD or DV Series Magnetic Resonance Scanner to produce diagnostic images of the upper and lower extremities, chest, abdomen, pelvis, head, neck, and spine in pediatric and adult populations that can be interpreted by a trained physician.
The NeoCoil 1.5T GEM Flex Coil is a receive-only phased array coil system for imaging the upper and lower extremities, chest, abdomen, pelvis, head, neck, and spine in pediatric and adult populations. This system consists of:
- Three formable, flexible and detachable antennae of different size that can be wrapped or orientated flat, in order to accommodate various anatomic shapes and sizes.
- A multichannel low-noise coil interface matched to the MRI scanner for compatibility with 8 or 16 channel systems.
- Multi-purpose accessory immobilization devices designed for patient comfort and reduced motion artifacts.
The NeoCoil 1.5T GEM Flex Coil 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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the NeoCoil 1.5T GEM Flex Coil:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Pass/Fail Criteria | Reported Device Performance |
|---|---|---|
| Max B1 in first fault conditions | Pre-defined performance standards | Pass: coil does not arc or show any signs of voltage breakdown |
| Surface Temperature in normal and first fault conditions | Pre-defined performance standards | Pass: RF heating is not greater than 39° C in normal or first fault conditions |
| NEMA MS 6-2008 | Pre-defined performance standards | Pass: Expanded indications do not change acceptance criteria initially established for the 1.5T MetaFlexCoil (K101632); SNR and Uniformity are consistent with the requirements for indications for use. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document describes clinical performance testing that included "a mix of scanner configurations, pulse sequences, imaging options, field of view and anatomy" and "imaging from the pediatric subpopulations specified in Table 1 of the FDA guidance, Premarket Assessment of Pediatric Medical Devices." However, specific sample sizes for the test set (number of patients or cases) are not explicitly stated in the provided text.
The data provenance is implied to be prospective clinical testing as it refers to "clinical data submitted" and "No adverse events were reported during clinical performance testing." The country of origin of the data is not specified, but it's for an FDA 510(k) submission, suggesting it would adhere to US regulatory standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document states that the device is used to produce "diagnostic images... that can be interpreted by a trained physician." However, it does not specify the number of experts or their qualifications used to establish a ground truth for the clinical test set. The evaluation seems to be based on the general interpretation capability by "trained physicians" rather than a formal expert consensus process as typically defined for ground truth establishment in AI/CAD studies.
4. Adjudication Method for the Test Set
The provided text does not describe any specific adjudication method (e.g., 2+1, 3+1) for the clinical test set.
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 comparative effectiveness study was done as this device is a physical coil, not an AI or CAD system designed to assist human readers. The clinical testing was to demonstrate the performance and safety of the coil itself.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to an MRI coil, not an algorithm, so the concept of "standalone performance" for an algorithm is not applicable. The device itself (the coil) was tested for its performance characteristics.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the clinical performance testing, the ground truth is implicitly the ability of "trained physicians" to interpret the diagnostic images produced by the coil. It's not explicitly defined as expert consensus, pathology, or outcomes data. The study primarily evaluated if the coil produced images of sufficient quality for diagnosis, rather than attempting to classify specific disease states against a gold standard.
For the bench tests, the "ground truth" was the pre-defined performance standards (e.g., specific voltage breakdown limits, temperature limits, NEMA standards).
8. The Sample Size for the Training Set
This device is an MRI coil, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for an AI/ML algorithm, this question is 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.