(7 days)
The GE Functional Brain Mapping Option is a software and hardware package that can be used to acquire, process and display the results of BOLD (blood oxygen level dependent) MRI scan studies taken in the presence of synchronized stimuli presented to a person being scanned. When interpreted by a trained physician these results may be useful in the determination of a course of treatment.
The GE BrainWave Option(s) for MRI systems is a modification to the GE Functional Brain Mapping Imaging Option for MRI systems. The GE BrainWave Option(s) produces difference images highlighting changes in blood oxygen level dependent (BOLD) images over time. These differences corresponding to changing stimuli presented to patients that are synchronized with scanning. The resulting parametric or activation images are superimposed on structural images from the same patient. The device can be used to acquire, process and display the results of BOLD (blood oxygen level dependent) MRI studies with or without external stimulation hardware.
The GE 510(k) summary for "GE BrainWave Option(s) for MRI systems" states that the device was evaluated against NEMA performance standards and IEC 60601-1 and IEC 60601-2-33 international medical equipment safety standards. The document concludes that the GE BrainWave Option(s) is comparable to the currently marketed GE Functional Brain Mapping Option for MRI systems and does not result in any new potential hazards.
However, the provided text does not contain specific acceptance criteria in terms of diagnostic performance metrics (e.g., sensitivity, specificity, accuracy) or the results of a study demonstrating the device meets such criteria. Instead, it focuses on regulatory equivalence to a predicate device and compliance with safety standards.
Therefore, many of the requested details cannot be extracted from this document.
Here's a breakdown of what can be extracted or inferred, and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Compliance with NEMA performance standards | Evaluated to appropriate NEMA performance standards. |
| Compliance with IEC 60601-1 (International Medical Equipment Safety) | Evaluated to IEC 60601-1. |
| Compliance with IEC 60601-2-33 (Particular Requirements for Safety of Magnetic Resonance Equipment for Medical Diagnosis) | Evaluated to IEC 60601-2-33. |
| (Missing: Specific diagnostic performance metrics e.g., sensitivity, specificity, accuracy) | (Missing: Quantitative results for diagnostic performance) |
| Not creating new potential hazards compared to predicate | "does not result in any new potential hazards." |
| Substantial equivalence to predicate device (GE Functional Brain Mapping Option for MRI systems) | "is substantially equivalent to the currently marketed GE Functional Brain Mapping Option for MRI systems." |
2. Sample size used for the test set and the data provenance
- Not provided. The document mentions evaluation against standards but does not describe a clinical performance study with a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not provided. Ground truth establishment is not discussed as no clinical performance study is detailed.
4. Adjudication method for the test set
- Not provided. Not applicable as no clinical performance study is detailed.
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
- Not provided. The document does not describe an MRMC study or compare human performance with and without the device. The device is described as "producing difference images highlighting changes in blood oxygen level dependent (BOLD) images over time." It's an imaging option, not specifically an AI-driven interpretive tool in the modern sense.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not provided. The document describes the device as providing results to be "interpreted by a trained physician," implying human-in-the-loop, but does not detail a standalone performance evaluation.
7. The type of ground truth used
- Not provided. No clinical performance study is detailed.
8. The sample size for the training set
- Not provided. No details on a training set are given, as this sounds like a system modification and safety/equivalence demonstration rather than a de novo AI model development.
9. How the ground truth for the training set was established
- Not provided. Not applicable as no training set is discussed.
§ 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.