(91 days)
The Brivo MR355/ Optima MR360 is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being imaged, contrast agents may be used. The images produced by the Brivo MR355/ Optima MR360 reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
The Brivo MR355 / Optima MR360 is a new MR system that is similar in design to previous GE Healthcare 1.5T MR systems. All utilize superconducting magnets, gradients, and radio frequency coils and electronics to acquire data in single voxel, two dimensional, or three dimensional datasets. The 1.5T Brivo MR355 / Optima MR360 features a superconducting magnet operating at 1.5 Tesla. The data acquisition system accommodates up to 8 independent receive channels in various increments, and multiple independent coil elements per channel during a single acquisition series. The system uses a combination of time-varying magnetic fields (gradients) and RF transmissions to obtain information regarding the density and position of elements exhibiting magnetic resonance. The system can image in the sagittal, coronal, axial, oblique and double oblique planes, using various pulse sequences and reconstruction algorithms. The 1.5T Brivo MR355 / Optima MR360 is designed to conform to NEMA DICOM standards (Digital Imaging and Communications in Medicine).
The provided text is for a GE Brivo MR355/Optima MR360 510(k) Premarket Notification and does not describe acceptance criteria for an AI/ML powered device, nor does it detail a study proving its performance against such criteria. The document is for a traditional Magnetic Resonance Diagnostic Device.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, training set sample size, how training ground truth was established) are not applicable to the provided information.
However, I can extract the performance parameters that were tested for this device, which can be interpreted as its "acceptance criteria" in the context of it being a new MR system demonstrating substantial equivalence to predicate devices.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Measured Parameters) | Reported Device Performance |
|---|---|
| Signal-to-noise ratio (SNR) | Documented through testing. |
| Geometric distortion | Documented through testing. |
| Image uniformity | Documented through testing. |
| Slice thickness | Documented through testing. |
| Spatial resolution | Documented through testing. |
| Static field strength | Documented through testing. |
| Acoustic noise | Documented through testing. |
| Gradient output (dB/dt) | Documented through testing. |
| RF output (SAR) | Documented through testing. |
| Biocompatibility | Documented through testing. |
| Clinical Images | "All images show that the system meets the indications for use." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "Clinical images collected by volunteer scanning," indicating a prospective collection method using volunteers. No specific numerical sample size (number of volunteers or images) is given, nor is the country of origin of the data specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided. The document states that the images, when "interpreted by a trained physician yield information that may assist in diagnosis," but it does not detail an expert review process for establishing ground truth as one might for an AI/ML study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
A MRMC comparative effectiveness study was not described. This document pertains to a new MR imaging system, not an AI/ML algorithm intended to assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not applicable as the device is an MR scanner, not an AI/ML algorithm. The performance tests described (SNR, image uniformity, etc.) demonstrate the standalone performance of the MR system itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the performance parameters, the "ground truth" implicitly refers to the physical measurements and standards (NEMA, IEC, ISO). For the clinical images, the statement "All images show that the system meets the indications for use" suggests an assessment against clinical expectations or previous interpretations, likely by trained physicians, but the specific type of ground truth (e.g., expert consensus on specific findings, pathology correlation) is not detailed.
8. The sample size for the training set
The concept of a "training set" is not applicable as this is a traditional MR imaging device, not an AI/ML model that undergoes a training phase.
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.