(9 days)
The GE Delta Software Option for MRI is an analytical software tool, which provides reproducible tools for the review and reporting of medical images. Delta can import medical images from a MR system and display them in a viewing area on the computer screen. The viewing area allows the access to multiple studies and series of multi-slice, multi-phase images. Multi-phase sequences of images can be displayed in a cine mode to facilitate visualization.
A report input interface is also available. Measurement tools on the report interface make it possible to quickly and reliably fill out a complete clinical report of an imaging exam. Available tools include: point, distance, area, and volume measurement tools such as ejection fraction, cardiac output, end-diastolic volume, end-systolic volume, and volume flow measurements.
The results of the measurement tools are interpreted by the physician and can be communicated to referring physicians.
When interpreted by a trained physician these tools may be useful in supporting the determination of a diagnosis.
The GE Delta Software Option for MRI is an analytical software application intended to review and analyze medical images.
The provided document does not contain acceptance criteria or a study that proves the device meets specific performance criteria. Instead, it details a 510(k) premarket notification for the GE Delta Software Option for MRI, focusing on substantial equivalence to predicate devices and adherence to safety standards.
Here's a breakdown of what is and is not in the document regarding your request:
1. Table of Acceptance Criteria and Reported Device Performance:
- Not Found: The document does not specify any quantitative acceptance criteria (e.g., accuracy thresholds, precision targets) for the software's analytical capabilities (e.g., ejection fraction, cardiac output measurements). Consequently, there are no reported device performance metrics against such criteria. The "Summary of Studies" section only mentions evaluation against safety standards (IEC60601-1-4 and IEC 60601-2-33) for software and MR systems, not clinical performance.
2. Sample size used for the test set and data provenance:
- Not Found: There is no mention of a test set, sample size, or data provenance (e.g., country of origin, retrospective/prospective) for evaluating the device's diagnostic or measurement accuracy. The studies mentioned are related to electrical and software safety, not clinical performance.
3. Number of experts used to establish the ground truth for the test set and their qualifications:
- Not Found: Since no clinical performance study or test set is described, there's no information about experts used to establish ground truth.
4. Adjudication method for the test set:
- Not Found: No clinical performance study, thus no adjudication method is mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
- Not Found: The document describes the GE Delta Software as an "analytical software tool" with "reproducible tools for the review and reporting of medical images," including various measurement tools. It states that "When interpreted by a trained physician these tools may be useful in supporting the determination of a diagnosis." However, it does not describe any MRMC comparative effectiveness study, nor does it quantify any improvement in human reader performance with or without the AI assistance (as it's more of a quantitative measurement tool than a diagnostic AI).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Found: No standalone performance study, defined as "algorithm only without human-in-the-loop performance," is described. The device is presented as a tool to be used by a trained physician.
7. The type of ground truth used:
- Not Found: No clinical performance study means no ground truth type (e.g., expert consensus, pathology, outcomes data) is mentioned.
8. The sample size for the training set:
- Not Found: There's no mention of a training set as this is not a study describing the development or validation of a machine learning algorithm in the way modern AI devices are presented. It's a software option providing measurement tools.
9. How the ground truth for the training set was established:
- Not Found: No training set, thus no ground truth establishment method.
In summary: The provided 510(k) pertains to the regulatory clearance of a software option for MRI that provides measurement and reporting tools, asserting its substantial equivalence to predicate devices (MEDIS Medical Imaging Systems FLOW and MASS). The evaluation focuses on safety standards (IEC60601-1-4, IEC 60601-2-33) for programmable electrical medical systems and MRI systems, rather than clinical performance metrics or studies involving patient data, ground truth, or reader performance.
§ 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.