(51 days)
The Optima™ MR450w 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 Optima™ MR450w 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 1.5T GE Optima MR450w features a superconducting magnet operating at 1.5 Tesla. The data acquisition system accommodates up to 32 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 Optima MR450w is proposed to be marketed with an added XP Gradient configuration compatible with systems that have the GEM Coil Suite option. The 1.5T GE Optima MR450w is designed to conform to NEMA DICOM standards (Digital Imaging and Communications in Medicine).
The GE Optima MR450w is a magnetic resonance diagnostic device and does not have specific computational acceptance criteria like an AI-powered diagnostic tool. Instead, the "acceptance criteria" are based on compliance with voluntary standards and the satisfactory performance across a range of technical and safety tests.
Here's a breakdown of the information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Non-Clinical Tests) | Reported Device Performance |
|---|---|
| Risk Analysis | Complies |
| Requirements Reviews | Complies |
| Design Reviews | Complies |
| Performance testing: | |
| Signal-to-noise ratio (SNR) | Tested |
| Geometric distortion | Tested |
| Image uniformity | Tested |
| Slice thickness | Tested |
| Spatial resolution | Tested |
| Component, Subsystem and System Testing (Verification) | Complies |
| Simulated use testing (Validation) | Complies |
| Safety Testing: | |
| Static Field Strength | Tested |
| Acoustic noise | Tested |
| DB/dt | Tested |
| RF heating (SAR) | Tested |
| Biocompatibility | Tested |
2. Sample Size Used for the Test Set and Data Provenance:
The document explicitly states: "The subject of this premarket submission, Optima MR450w did not require external clinical studies to support substantial equivalence. Internal scans for workflow and image quality data were used for clinical validation."
This indicates that internal, retrospective data was used, but no specific sample size for a "test set" in the context of clinical performance evaluation is mentioned. The focus was on engineering verification and validation rather than a clinical trial.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. The document does not describe a process of establishing ground truth for a clinical test set with expert adjudicators. Clinical validation was based on "internal scans for workflow and image quality data," implying internal review by presumably qualified GE personnel rather than a formal expert consensus process as seen in clinical AI studies.
4. Adjudication Method for the Test Set:
Not applicable. No formal adjudication method is described, as the device did not undergo external clinical studies requiring expert consensus on a clinical test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No. The document explicitly states: "The subject of this premarket submission, Optima MR450w did not require external clinical studies to support substantial equivalence." Therefore, no MRMC study comparing human readers with and without AI assistance was performed.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Not applicable. The Optima MR450w is a diagnostic imaging device, not an AI algorithm. Its performance is inherent in the image quality it produces, which is then interpreted by a trained physician. The "standalone" performance is the image quality itself, which was validated through the non-clinical tests listed.
7. Type of Ground Truth Used:
For the non-clinical performance tests (SNR, geometric distortion, etc.), the "ground truth" would be established by validated measurement standards and engineering specifications. For the "internal scans for workflow and image quality data," the ground truth would be based on established imaging protocols and subjective expert evaluation of image characteristics by internal GE staff. No pathology or outcomes data is mentioned as ground truth for this submission.
8. Sample Size for the Training Set:
Not applicable. The Optima MR450w is a hardware device (MRI scanner) with associated pulse sequences and reconstruction algorithms. It is not an AI algorithm that requires a "training set" in the conventional machine learning sense. Its design and algorithms are based on established physics and engineering principles, not statistical learning from a dataset.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no "training set" in the machine learning context for this 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.