(29 days)
The GE Signa® HDx MR system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. The Signa® HDx MR system is indicated for use as a diagnostic imaging device to produce axial sagittal, coronal and oblique images, spectroscopic images, and/or spectra, dynamic images of the internal structures and organs of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. The images produced by the Signa® HDx system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
The 1.5T and 3.0T Signa® HDx MR systems are a modification to the previously cleared MR systems K041476 which utilizes a superconducting magnet to acquire 2D single-slice and multi-slice, and 3D volume images. The 1.5T and 3.0T Signa® HDx Magnetic Resonance System features a superconducting magnet operating at either 1.5T, or 3.0T. The data acquisition system supports 1, 4, 8, 12, 16, 32 independent receive channels and multiple independent coil elements per channel during a single acquisition series. Additionally, the system architecture is designed for expansion in 16 channel increments. The system can image in the sagittal, coronal, axial, oblique and double oblique planes, using various pulse sequences. Images are acquired and reconstructed using 2D and 3D Fourier transformation techniques. The system is intended for high-resolution anafomical applications, short scan times, and multinuclear spectroscopy. The 1.5T Signa® HDx MR system is also available in a mobile configuration.
The GE 1.5T and 3.0T Signa® HDx MR Systems are modifications of previously cleared MR systems (K041476). The provided documentation does not contain specific acceptance criteria or a detailed study explicitly proving the device meets those criteria in the way a clinical performance study for an AI algorithm would. Instead, the submission focuses on demonstrating substantial equivalence to the predicate devices through technical modifications and compliance with general performance and safety standards.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not outline specific, quantitative acceptance criteria for image quality or diagnostic performance of the 1.5T and 3.0T Signa® HDx MR Systems in the way a new medical image analysis algorithm might. Instead, the primary "acceptance criterion" is conceptual: substantial equivalence to the predicate devices (Signa® Excite 1.5T MR system and Signa® Excite 3.0T MR system) in terms of safety and effectiveness, while offering improved technical capabilities.
The reported "device performance" is described in terms of these improvements and compliance with standards, rather than specific metrics like sensitivity or specificity.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate devices (K041476) | The 1.5T and 3.0T Signa® HDx MR Systems are considered substantially equivalent to the currently marketed Signa® Excite 1.5T and 3.0T MR systems, respectively. The systems maintain the same intended use. |
| Improved technical capabilities over predicate | Main differences: Change to receiver chain architecture with thirty-two independent receive channels (and future expansion in 16-channel increments). |
| Overall system improvements: Simplified User Interface, single 23" Liquid Crystal Display, improved multi-channel surface coil connectivity, improved image reconstruction architecture (Volume Recon Engine - VRE). | |
| Compliance with relevant performance standards | Evaluated to appropriate NEMA performance standards. |
| Compliance with relevant safety standards | Evaluated to IEC 60601-1 International Medical Equipment Safety standard and IEC 60061-2-33 Particular Requirements for Safety of Magnetic Resonance Equipment for Medical Diagnosis. |
| No new potential hazards introduced | It is the opinion of GE that usage of the 1.5T Signa® HDx Magnetic Resonance System and the 3.0T Signa® HDx Magnetic Resonance System does not result in any new potential hazards. |
| Ability to produce high-resolution, high signal-to-noise ratio images, and short scan times for diagnostic use across various body parts | The Indications for Use state the system is "designed to support high resolution, high signal-to-noise ratio, and short scan times" and is "indicated for use as a diagnostic imaging device to produce axial sagittal, coronal and oblique images, spectroscopic images, and/or spectra, dynamic images of the internal structures and organs of the entire body...". The context implies that the improvements contribute to meeting these objectives effectively for diagnostic interpretation by a trained physician. |
2. Sample Size Used for the Test Set and Data Provenance
The submission does not describe a specific "test set" in the context of a clinical performance study using patient data or images to evaluate the device's diagnostic accuracy. The evaluation appears to be primarily technical, comparing the new system's specifications and performance against established standards (NEMA, IEC) and the predicate device. Therefore, information regarding "data provenance" (country of origin, retrospective/prospective) is not provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Since no test set for diagnostic accuracy is described, there is no mention of experts used to establish ground truth or their qualifications. The evaluation is focused on technical equivalence and safety, not on a clinical ground truth for diagnostic performance.
4. Adjudication Method for the Test Set
Given the absence of a test set for diagnostic performance, no adjudication method is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No MRMC comparative effectiveness study is mentioned. The submission makes no claims about human readers' improvement with or without AI assistance, as it is for an MR system itself, not an AI-assisted diagnostic tool.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not applicable as the submission concerns an MR imaging system, not a standalone algorithm.
7. The Type of Ground Truth Used
For the purpose of this 510(k), the "ground truth" is primarily:
- Predicate device specifications and performance: The fundamental aspect is proving that the new device is functionally equivalent or improved without introducing new safety concerns compared to the already cleared predicate.
- Compliance with recognized standards: NEMA performance standards, IEC 60601-1 (safety), and IEC 60061-2-33 (particular requirements for MR safety).
There is no mention of ground truth established through expert consensus, pathology, or outcomes data in the context of a diagnostic performance study.
8. The Sample Size for the Training Set
Not applicable. The submission does not describe an AI/ML algorithm that would require a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set or associated ground truth establishment is described.
In summary, this 510(k) submission for the GE 1.5T and 3.0T Signa® HDx MR Systems focuses on demonstrating substantial equivalence to existing predicate devices based on technical modifications, safety compliance, and adherence to recognized performance standards, rather than a clinical performance study with defined acceptance criteria and ground truth for diagnostic accuracy.
§ 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.