(11 days)
The Discovery MR450 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 Discovery MR450 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 GE Discovery MR450 is a new MR system that is substantially equivalent to previously cleared 1.5T /3.0T 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 GE Discovery MR450 features a superconductina 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 (aradients) 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 GE Discovery MR450 is designed to conform to NEMA DICOM standards (Diaital Imagina and Communications in Medicine).
The provided text is a 510(k) Premarket Notification for the GE Discovery MR450. It does not contain information about acceptance criteria and a study proving the device meets those criteria in the typical format of a clinical or performance study evaluating an AI/diagnostic algorithm's accuracy, sensitivity, or specificity.
Instead, this document focuses on demonstrating substantial equivalence to predicate devices. The "performance" section refers to technical specifications and compliance with standards rather than clinical performance metrics against a defined ground truth.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" for a diagnostic performance study, nor does it report specific "device performance" in terms of clinical accuracy, sensitivity, or specificity in the context of disease detection or diagnosis.
The "Performance" section outlines parameters that have been measured and documented through testing to NEMA, IEC, or ISO standards, suggesting the acceptance criteria are adherence to these technical standards.
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Compliance with NEMA standards | Measured and documented performance (Signal-to-noise ratio, Geometric distortion, Image uniformity, Slice thickness, Spatial resolution) to NEMA, IEC, or ISO standards. |
| Compliance with IEC standards | Designed to comply with applicable IEC standards. Shall be certified by a Nationally Recognized Testing Laboratory to conform to IEC, UL, and CSA standards prior to commercialization. |
| Compliance with UL and CSA standards | Shall be certified by a Nationally Recognized Testing Laboratory to conform to IEC, UL, and CSA standards prior to commercialization. |
| (Safety standards) | Tested for Static field strength, Acoustic noise, dB/dt, RF heating (SAR), Biocompatibility. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The document refers to testing "to NEMA, IEC or ISO standards" for technical parameters, not a clinical test set with patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided. The document does not describe a test set that would require expert-established ground truth in a diagnostic context.
4. Adjudication Method for the Test Set
This information is not provided. An adjudication method is not applicable given the type of testing described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done or described in this submission. The submission focuses on substantial equivalence based on technical specifications and indications for use, not on improving human reader performance with AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was Done
This document describes a medical imaging device (MRI scanner), not an AI algorithm. Therefore, a standalone algorithm performance study is not applicable and was not done.
7. The Type of Ground Truth Used
The concept of "ground truth" as pathology, outcomes data, or expert consensus is not applicable to the type of technical performance testing described for an MRI scanner in this submission. The ground truth for parameters like "Signal-to-noise ratio" or "Geometric distortion" would be defined by the measurement standards themselves (e.g., specific phantoms and procedures).
8. The Sample Size for the Training Set
This information is not provided. The document describes an MRI system, not a device incorporating a machine learning or AI component that would have a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not provided and is not applicable as there is no mention of a training set for a machine learning model.
Summary of the Study for Substantial Equivalence:
The "study" described in the 510(k) is a comparison to predicate devices and technical testing to established industry standards (NEMA, IEC, ISO). The document states:
- "As stated in the FDA document 'Guidance for the Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices' the following parameters have been measured and documented through testing to NEMA, IEC or ISO standards..." (Section 3)
The parameters tested include:
- Performance: Signal-to-noise ratio (SNR), Geometric distortion, Image uniformity, Slice thickness, Spatial resolution
- Safety: Static field strength, Acoustic noise, dB/dt, RF heating (SAR), Biocompatibility
The conclusion is that the GE Discovery MR450 is substantially equivalent to the predicate GE 1.5T Signa® HDx MR System and GE Signa® MR750, based on similar indications for use, technical specifications, and compliance with relevant industry and safety standards. There is no mention of clinical accuracy or diagnostic performance studies involving patients or human readers.
§ 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.