(98 days)
The Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T and the Optima MR450w 1.5T systems are whole body magnetic resonance scanners 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 Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T and the Optima MR450w 1.5T systems 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 Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T and the Optima MR450w 1.5T are whole body magnetic resonance scanners designed to support high resolution, high signal-to-noise ratio, and short scan times. The systems feature a superconducting magnet operating at 1.5 Tesla or 3.0 Telsa. 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.
This Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, and the Optima MR450w 1.5T systems are designed to conform to NEMA DICOM standards (Digital Imaging and Communications in Medicine).
Modification for which this Special 510(k) is being filed is a Training PC which was introduced in the DV25.1 program. This modification allows users to train new technologist, optimize protocols, and evaluate pulse sequence development in the off-line environment.
The provided text is a 510(k) summary for a GE Medical Systems device, the Discovery MR750, Discovery MR450, Discovery MR750w, and Optima MR450w MR systems. The submission is for a modification to the existing predicate devices, specifically the introduction of a "Training PC."
Therefore, the document does not contain information about a study proving the device meets acceptance criteria for its core diagnostic function. Instead, it focuses on demonstrating substantial equivalence for the new modification (the Training PC) to the predicate devices.
Here's a breakdown of the requested information based on the provided text, and where it is missing for a typical medical device performance study:
1. A table of acceptance criteria and the reported device performance
- Missing. The document does not describe specific acceptance criteria for diagnostic performance or reported performance metrics of the MRI system's imaging capabilities. The modification is for a "Training PC," and the "performance" described relates to compliance with standards and quality assurance processes for this feature.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Missing. No clinical or image-based test set information is provided as the submission is not for a new diagnostic device but a modification (Training PC).
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)
- Missing. No information on experts or ground truth establishment is provided as there is no diagnostic image test set described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Missing. No information on adjudication is provided.
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
- Missing. No MRMC study was done, as this submission is for a modification to an existing MRI system's training component, not a new AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Missing. Not applicable. This is not an algorithm-only device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Missing. No ground truth data is described.
8. The sample size for the training set
- Missing. No training set information is provided, as the submission concerns a "Training PC" (a computer for user training) and not an AI algorithm's training data.
9. How the ground truth for the training set was established
- Missing. Not applicable.
Information Present in the Document (Related to the "Training PC" Modification):
The document states:
- Device Description (Modification): "Modification for which this Special 510(k) is being filed is a Training PC which was introduced in the DV25.1 program. This modification allows users to train new technologist, optimize protocols, and evaluate pulse sequence development in the off-line environment." (Page 4)
- Non-Clinical Tests: The system (with the Training PC addition) "complies with the NEMA standards, including NEMA PS3.1-3.20 for DICOM conformance." (Page 5)
- Quality Assurance Measures applied to the development of the system with the addition of the new feature training PC:
- Risk Analysis
- Requirements Reviews
- Design Reviews
- Testing on unit level (Module verification)
- Integration testing (System verification)
- Simulated use testing (Validation) (Page 5)
- Clinical Tests: "The modification that prompted this submission did not require clinical testing." (Page 5)
- Conclusion: "GE Healthcare considers the Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, and Optima MR450w 1.5T to be as safe, as effective, and performance is substantially equivalent to the predicate device(s)." (Page 5)
In summary, this document is a 510(k) for a minor modification (a training component) to an already cleared MRI system. It relies heavily on non-clinical testing showing compliance with standards and internal quality assurance processes to demonstrate substantial equivalence for the modification, rather than providing diagnostic performance data for the core MRI system or its "Training PC" feature.
§ 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.