(102 days)
The Discovery MR750 3.0T 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, TMI, 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 3.0Tsystem 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 features a superconducting magnet operating at 3.0 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 Discovery MR750 3.0T uses multi-drive RF transmit for imaging of the head and body regions.
Here's a breakdown of the acceptance criteria and study information for the GE Discovery MR750 3.0T, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated Goal) | Reported Device Performance |
|---|---|
| Maintains same imaging performance results as predicate device (K132376) | "The clinical results demonstrated that the Discovery MR750 3.0T maintains the same imaging performance results as its predicate device (K132376)." |
| Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-33 | The device "complies with the following voluntary standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-33" |
| Compliance with NEMA DICOM standards (NEMA PS3.1-3.20) | The device is "in compliance with the applicable NEMA standards, including NEMA PS3.1-3.20 for DICOM conformance." |
| Successful completion of verification testing with defined pass/fail criteria | "The testing was completed with passing results per the pass/fail criteria defined in the test cases." |
2. Sample Size Used for the Test Set and the Data Provenance
The document states: "Internal scans were conducted as part of validation for workflow and image quality for the addition of the new feature."
- Sample Size: Not explicitly stated. The term "internal scans" typically implies a smaller, controlled set of images used for engineering validation rather than a large clinical trial.
- Data Provenance: "Internal scans" suggests the data was generated internally by GE Healthcare, likely on their own test subjects or phantoms. There is no mention of country of origin or whether it was retrospective or prospective in a clinical sense; it appears to be primarily technical validation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided in the document. The study described focuses on technical and imaging performance comparison to a predicate, rather than an assessment requiring expert ground truth in a diagnostic context.
4. Adjudication Method for the Test Set
This information is not provided in the document. Given the nature of the "internal scans" for workflow and image quality validation, a formal adjudication process as seen in clinical trials with multiple expert readers is unlikely to have been employed.
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
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study described is a technical and imaging performance comparison, not an AI-assisted diagnostic study. Therefore, there is no information on human reader improvement with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device itself is a Magnetic Resonance Diagnostic Device, not an AI algorithm. The tests performed were on the imaging system's performance, not a standalone algorithm.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The document implies that the ground truth for performance was the performance of the predicate device (K132376). The goal was to demonstrate that the new device "maintains the same imaging performance results as its predicate device." This suggests a comparative "ground truth" rather than an independent gold standard like pathology. For technical performance, compliance with standards (IEC, NEMA) would also serve as a form of "ground truth."
8. The Sample Size for the Training Set
There is no mention of a training set. This type of device (a magnetic resonance scanner) does not typically involve a machine learning training set in the way an AI diagnostic algorithm would. The development involves engineering and software updates, and validation against established technical standards and predicate performance.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set, this information is not applicable/not provided.
§ 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.