(14 days)
The GE Signa® MR750 System 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 GE Signa® MR750 System 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 3.0T GE Signa® MR750 System is a new MR system that is substantially equivalent to previously cleared 3.0T MR systems. All utilize superconducting magnets to acquire 2D single-slice and 3D volume images. The 3.0T GE Signa® MR750 System features a superconducting magnet operating at 3.0Tesla. The data acquisition system accommodates up to 32 independent receive channels 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. Images are acquired and reconstructed using 2D and 3D Fourier transformation. The 3.0T GE Signa® MR750 System is designed to conform to NEMA DICOM standards (Digital Imaging and Communications in Medicine).
The provided text is a 510(k) Premarket Notification for the GE 3.0T Signa® MR750 System. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study with a test set, ground truth, and expert readers in the way an AI/ML device submission would.
Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not applicable or extractable from this type of submission.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance:
The document lists performance parameters that were measured and documented through testing to NEMA, IEC, or ISO standards, but it does not provide specific acceptance criteria (e.g., "SNR must be > X dB") or reported performance values beyond stating that the device has been designed to comply and has been measured and documented.
| Performance Parameter | Acceptance Criteria (Not explicitly stated as numerical values) | Reported Device Performance (No numerical performance given, only compliance) |
|---|---|---|
| Signal-to-noise ratio (SNR) | N/A (Implied compliance with standards) | Measured and documented through testing to NEMA, IEC or ISO standards. |
| Geometric distortion | N/A (Implied compliance with standards) | Measured and documented through testing to NEMA, IEC or ISO standards. |
| Image uniformity | N/A (Implied compliance with standards) | Measured and documented through testing to NEMA, IEC or ISO standards. |
| Slice thickness | N/A (Implied compliance with standards) | Measured and documented through testing to NEMA, IEC or ISO standards. |
| Spatial resolution | N/A (Implied compliance with standards) | Measured and documented through testing to NEMA, IEC or ISO standards. |
For safety parameters:
| Safety Parameter | Acceptance Criteria (Not explicitly stated as numerical values) | Reported Device Performance (No numerical performance given, only compliance) |
|---|---|---|
| Static field strength | N/A (Implied compliance with standards) | Measured and documented through testing to NEMA, IEC or ISO standards. |
| Acoustic noise | N/A (Implied compliance with standards) | Measured and documented through testing to NEMA, IEC or ISO standards. |
| DB/dt | N/A (Implied compliance with standards) | Measured and documented through testing to NEMA, IEC or ISO standards. |
| RF heating (SAR) | N/A (Implied compliance with standards) | Measured and documented through testing to NEMA, IEC or ISO standards. |
| Biocompatibility | N/A (Implied compliance with standards) | Measured and documented through testing to NEMA, IEC or ISO standards. |
The document states: "The 3.0T MR750 MR system has been designed to comply with applicable IEC standards. It shall be certified by a Nationally Recognized Testing Laboratory to conform to IEC, UL and CSA standards prior to commencement of system production." This indicates the intent and plan for compliance rather than presenting specific performance results from a study.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable. This is not a study assessing an algorithm's performance on a dataset of patient images. It's a submission for an imaging device (MRI scanner) demonstrating substantial equivalence based on technical specifications and compliance with safety and performance standards.
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):
Not applicable. No ground truth establishment for a patient image test set is described. The "trained physician" mentioned in the "Indications for Use" refers to the user of the device, not an expert establishing ground truth for a study within this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No test set adjudication is described.
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:
Not applicable. This is a submission for an MRI scanner, not an AI or CAD device. There is no mention of human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is not an algorithm, but an MRI hardware system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable. There is no concept of "ground truth" used in the context of an image interpretation study within this document. The "ground truth" for verifying the performance of the MR system itself would be established through a variety of engineering and physics measurements and certifications against standards.
8. The sample size for the training set:
Not applicable. This is not an AI/ML device; there is no training set mentioned.
9. How the ground truth for the training set was established:
Not applicable. No training set is involved.
§ 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.