(108 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 signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, coronal, and oblique images, spectroscopic images, parametric maps, and or spectra, dynamic images of the structures of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, 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 MR750w 3.0T and the Optima MR450w I.ST systems reflect the spaial 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 Systems are whole body magnetic resonance scanners designed to support high resolution, high signal-to-noise ratio, and short scan times. The Systems each feature a superconducting magnet. 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. Each 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. Each system can image in the sagittal, coronal, axial, oblique, and double oblique planes, using various pulse sequences and reconstruction algorithms.
The DV24 release is introducing new software features onto these existing MR Systems. There are also hardware modifications to the GEM configurations for Silenz compatibility. The Silenz feature used to reduce the acoustic noise generated during an MR examination is only available on the Optima MR450w GEM and Discovery MR750w GEM configurations.
The 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).
The GE Healthcare Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, and Optima MR450w 1.5T Magnetic Resonance Diagnostic Devices did not undergo a study with specific acceptance criteria related to new AI features or performance metrics. This is because the submission (K132376) primarily focused on the introduction of new software features (DV24 release) and hardware modifications for Silenz compatibility on existing MR systems.
The submission states: "The subject of this premarket submission... did not require external clinical studies to support substantial equivalence." Instead, the focus was on demonstrating that the updated systems maintain the same imaging performance as their predicate devices.
Here's a breakdown of the information based on the provided document, addressing the requested points where applicable, and noting where the information is not provided because it pertains to an AI/performance study that was not conducted:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| New Software Features (DV24 release) and Silenz Compatibility: Maintain imaging performance and safety profile substantially equivalent to predicate devices (Discovery MR750w 3.0T [K130115] and Optima MR450w 1.5T [K123522]). | "The clinical results demonstrated that the Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T and the Optima MR450w 1.5T maintain the same imaging performance results as its predicate devices (K123522 and K130115)." |
| Compliance with Voluntary Standards: | The systems comply with IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-1-6, IEC 60601-2-33, IEC 62304, IEC 62366, ISO 14971, and NEMA PS3.1-3.20 (DICOM). |
| Quality Assurance Measures: Successful completion of risk analysis, requirements reviews, design reviews, unit level testing, integration testing, performance testing, safety testing, and simulated use testing. | "Verification testing for the new software features has been completed with passing results." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for a dedicated test set against specific performance criteria. "Internal scans were conducted as part of validation for workflow and image quality for the addition of the new features." The exact number of scans is not provided.
- Data Provenance: "Internal scans" suggests the data was generated within GE Healthcare. The country of origin and whether it was retrospective or prospective is not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not provided. The study did not involve establishing a ground truth by experts in the context of a comparative performance study. The focus was on maintaining existing performance standards.
4. Adjudication Method for the Test Set
- Not applicable as a traditional adjudication method for a performance study was not described.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
- No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not described or performed for this submission. The submission explicitly states, "The subject of this premarket submission... did not require external clinical studies to support substantial equivalence."
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This submission relates to physical MR imaging devices and software updates, not a standalone AI algorithm with specific performance metrics.
7. The Type of Ground Truth Used
- No explicit "ground truth" as typically defined for AI performance studies was established. The "ground truth" was implicitly the existing imaging performance of the predicate devices. The internal validation aimed to ensure the new features did not degrade this established performance.
8. The Sample Size for the Training Set
- This information is not applicable. The document does not describe the development of a machine learning model with a separate training set. The "new software features" refer to changes in the MR system's operational software, not an AI algorithm trained on a dataset.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there was no described training set for an AI algorithm.
§ 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.