(52 days)
The Optima MR450w is a whole body magnetic resonance scanner designed to support high resolution and high signal-to-noise ratio images in short exam times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique anatomical images, spectroscopic data, parametric maps, or dynamic images of the structures or functions of the entire body. The indication for use includes, but is 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 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 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 whole-body magnetic resonance scanner. The provided text, a 510(k) summary, outlines its safety and performance characteristics in comparison to a predicate device, the GE Discovery® MR450 System (K083147).
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state quantitative acceptance criteria or a direct "reported device performance" table in the format usually seen for diagnostic algorithms. Instead, it refers to compliance with established standards (NEMA, IEC, ISO) and states that performance parameters were "measured and documented through testing to NEMA, IEC or ISO standards."
However, based on the Summary of Studies section, the performance parameters evaluated and implicitly deemed acceptable are:
| Acceptance Criteria (Parameter Evaluated) | Reported Device Performance (Implicitly Met) |
|---|---|
| Signal-to-noise ratio (SNR) | Complies with NEMA, IEC, or ISO standards |
| Geometric distortion | Complies with NEMA, IEC, or ISO standards |
| Image uniformity | Complies with NEMA, IEC, or ISO standards |
| Slice thickness | Complies with NEMA, IEC, or ISO standards |
| Spatial resolution | Complies with NEMA, IEC, or ISO standards |
| Static field strength | Complies with NEMA, IEC, or ISO standards |
| Acoustic noise | Complies with NEMA, IEC, or ISO standards |
| RF heating (SAR) | Complies with NEMA, IEC, or ISO standards |
| Biocompatibility | Complies with NEMA, IEC, or ISO standards |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a "test set" in the context of an algorithm or AI model evaluation. The studies described are physical performance and safety tests of the MR scanner itself. Therefore, sample sizes for medical images or patient data are not relevant or provided here. The tests are in accordance with NEMA, IEC, or ISO standards, which dictate the procedures and specifications for evaluating MR system performance and safety.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable. The studies concern the fundamental physical and electrical performance of the MR scanner, not the diagnostic accuracy of interpretations based on images from the device. Ground truth, in this context, would be established by validated measurement equipment and adherence to engineering and safety standards, rather than expert interpretation of medical images.
4. Adjudication Method for the Test Set:
Not applicable, as there's no "test set" of medical images or diagnostic interpretations being adjudicated. The tests are objective measurements against published standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:
No, an MRMC comparative effectiveness study was not done. This document describes the substantial equivalence of a new MR scanner model to a predicate device, focusing on its physical and safety performance. It does not involve human readers interpreting images with or without AI assistance, nor does it measure the effect size of AI on human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done:
No, a standalone algorithm performance study was not done. The device is an MR imaging hardware system, not an AI algorithm.
7. The Type of Ground Truth Used:
The ground truth for the evaluations described is based on established engineering, safety, and performance standards as defined by organizations like NEMA, IEC, and ISO. These standards dictate acceptable ranges and methodologies for measuring parameters such as SNR, geometric distortion, SAR, and acoustic noise. The "truth" is whether the device's measured performance falls within the specified limits of these standards.
8. The Sample Size for the Training Set:
Not applicable. The document is about the hardware and core functionality of an MR scanner, not an AI or machine learning model. Therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established:
Not applicable, for the same reasons as above.
§ 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.