(30 days)
The indications for use for the 3.0T Signa®VH/i (Signa® 3.0T MR System) Transmit/Receive Body Imaging Coil expands the imaging capability of the 3.0T Signa®VH/i MR Imaging System.
The Transmit/Receive Body Imaging Coil is intended for imaging of the Neck, Spine, Abdomen/Thorax and the extremities.
The Signa" 3.0T magnetic resonance system is a diagnostic imaging device that produces transverse, coronal, sagittal and oblique images of the internal structures of the head, neck, spine, abdomen/thorax and the extremities. The Signa® 3.0T system is designed to support high resolution imaging and multinuclear spectroscopy. Previously cleared software options, coils, and other accessories may be used with the Signa® 3.0T MR System.
The provided text describes a 510(k) summary for the GE Signa® 3.0T Magnetic Resonance System. However, it does not contain detailed information about specific acceptance criteria, device performance metrics (like sensitivity, specificity, or accuracy), or the methodology of a study designed to prove the device meets such criteria in the way typically expected for an AI/ML device.
Instead, this document focuses on demonstrating substantial equivalence to a predicate device, which is a different regulatory pathway than proving performance against pre-defined clinical metrics for a novel device or an AI/ML product. The "studies" mentioned are more likely engineering and safety tests to confirm that the modifications to the MR system operate as intended and are safe, rather than clinical performance studies measuring diagnostic accuracy.
Here's an analysis based on the information provided, highlighting the absence of typical AI/ML study details:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Not specified |
Explanation: The document states, "Testing was performed to demonstrate that the design modifications to the Signa® 3.0T MR System meet predetermined acceptance criteria." However, it does not describe what those acceptance criteria were in terms of specific performance metrics (e.g., image resolution, signal-to-noise ratio requirements, diagnostic accuracy targets). It also does not report any specific device performance metrics against such criteria. The conclusion only states "the Signa® 3.0T MR System is substantially equivalent to the currently cleared 3.0T Signa® VH/i transmit/Receive Body Imaging Coil and the 3.0 T Signa® VH/i system magnetic resonance system." This indicates that the "performance" demonstrated was primarily in terms of equivalency, not in meeting novel diagnostic performance benchmarks.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The text refers to "testing" performed but does not elaborate on the nature of this testing, including details about test sets, patient data, or study design. Since this is an MR system (hardware) rather than an AI/ML diagnostic algorithm, the "test set" would likely refer to physical testing or phantom studies, rather than a dataset of patient images with ground truth.
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 and is not relevant for the type of submission this appears to be. For substantial equivalence of an MR system, expert consensus on diagnostic images or ground truth establishment by multiple readers is not typically required in the same way it would be for an AI-powered diagnostic tool. The "ground truth" for an MR system often relates to its physical performance characteristics.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. Adjudication methods are typically associated with studies involving human interpretation of diagnostic data, especially for AI/ML devices where ground truth can be subjective or require expert consensus. This document does not describe such a study.
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
No, an MRMC comparative effectiveness study was not conducted based on the provided text. The device described is an MR imaging system (hardware), not an AI-assisted diagnostic tool. Therefore, the concept of comparing human reader performance with and without AI assistance is not applicable to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone performance study in the context of an algorithm or AI was not done. The device is a magnetic resonance system, which by its nature operates with a human operator and interpretation. There is no independent algorithm performance being assessed here.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
This information is not provided. Given that this is a 510(k) for an MR system, the "ground truth" for the tests performed (undescribed in detail) would more likely relate to engineering specifications, image quality metrics, or safety parameters, rather than clinically derived ground truth like pathology or outcomes data.
8. The sample size for the training set
This information is not provided as there is no mention of an algorithm requiring a training set in this submission.
9. How the ground truth for the training set was established
This information is not provided as there is no mention of an algorithm or a training set in this submission.
Summary of the document's content:
The document describes a 510(k) submission for the GE Signa® 3.0T Magnetic Resonance System. Its purpose is to demonstrate substantial equivalence to previously cleared MR systems (K990550 and K003613). The modifications involve combining existing components. The "studies" mentioned relate to proving that these design modifications meet "predetermined acceptance criteria," which are not detailed but are implied to be related to safety and performance characteristics for an MR system, allowing it to be considered substantially equivalent. This is a regulatory filing for a medical imaging device (hardware), not an AI/ML software product, and therefore the types of studies, criteria, and performance metrics expected differ significantly from those required for AI-driven diagnostic tools.
§ 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.