(40 days)
Vantage Galan 3T systems are indicated for use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body. Additionally, this system is capable of non-contrast enhanced imaging, such as MRA.
MRI (magnetic resonance imaging) images correspond to the spatial distribution of protons (hydrogen nuclei) that exhibit nuclear magnetic resonance (NMR). The NMR properties of body tissues and fluids are:
•Proton density (PD) (also called hydrogen density)
·Spin-lattice relaxation time (T1)
·Spin-spin relaxation time (T2)
·Flow dynamics
•Chemical Shift
Depending on the region of interest, contrast agents may be used. When interpreted by a trained physician, these images yield information that can be useful in diagnosis.
The Vantage Galan (Model MRT-30200) is a 3 Tesla Magnetic Resonance Imaging (MRI) System, previously cleared under K203323. This system is based upon the technology and materials of previously marketed Canon Medical Systems and is intended to acquire and display crosssectional, transaxial, coronal, sagittal, and oblique images of anatomic structures of the head or body.
The acceptance criteria and study that prove the device meets these criteria are detailed below:
1. Table of Acceptance Criteria & Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| No clinically-relevant difference in preference between the predicate Compressed SPEEDER (2D) images with an acceleration factor of 2.5 when compared to images with higher acceleration factors (3.0 and 4.0), ensuring all images remain diagnostic. | A human observer study demonstrated no clinically-relevant difference in preference between the predicate Compressed SPEEDER (2D) images with an acceleration factor of 2.5 and images with higher acceleration factors (3.0 and 4.0). The results showed that Compressed SPEEDER (2D) with acceleration factors of 2.5, 3.0, and 4.0 performed at the equivalent performance level to the commercially available predicate device. All images produced with each acceleration factor were deemed diagnostic. |
| All safety parameters (static field strength, operational modes, safety parameter display, operating mode access requirements, maximum SAR, maximum dB/dt, potential emergency condition, and means provided for shutdown) remain unchanged and meet specified standards (e.g., IEC 60601-2-33). | All safety parameters for the subject device (Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR) were found to be identical to those of the predicate device (K203323). This includes a static field strength of 3T, Normal and 1st Operating Modes, SAR and dB/dt display, screen access to 1st level operating mode, maximum SAR of 4W/kg for whole body, maximum dB/dt specified in IEC 60601-2-33, and shutdown by Emergency Ramp Down Unit for collision hazard for ferromagnetic objects. No changes were identified in these parameters. |
| Imaging performance parameters remain unchanged from the previous predicate submission (K203323). | The imaging performance parameters are reported as having no change from the previous predicate submission, K203323. |
2. Sample Size and Data Provenance for Test Set
- Sample Size: 32 studies and 116 scans were used for the human observer study.
- Data Provenance: Not explicitly stated whether the data was retrospective or prospective, nor the country of origin.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: Three board-certified radiologists per anatomy.
- Qualifications: "Board certified radiologists." No specific years of experience are mentioned.
4. Adjudication Method for Test Set
- The document implies a consensus-based approach for evaluating "clinically-relevant difference in preference" among the radiologists, but a specific adjudication method (e.g., 2+1, 3+1) is not explicitly stated.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- A human observer study was conducted comparing images from the predicate device (acceleration factor 2.5) with those from the subject device (higher acceleration factors 3.0 and 4.0). This can be considered a form of MRMC study, as multiple readers (three board-certified radiologists per anatomy) evaluated multiple cases (32 studies, 116 scans).
- Effect Size: The document states that the study demonstrated "no clinically-relevant difference in preference" and "equivalent performance level." This indicates no significant effect size of improvement with the higher acceleration factors (which implies AI processing, though not directly stated as "human readers improve with AI vs without AI assistance"). Instead, it shows that the AI-enhanced acceleration maintains diagnostic quality without degradation and without necessarily improving human reader performance beyond the predicate.
6. Standalone Performance Study (Algorithm Only)
- The document describes a "human observer study," which by its nature involves human readers. It does not explicitly state that a standalone algorithm-only performance study was conducted in terms of diagnostic accuracy or equivalent metrics without human-in-the-loop. The focus is on the human perception of image quality and diagnostic utility.
7. Type of Ground Truth Used
- The ground truth was based on expert consensus/preference from "board certified radiologists." They assessed "clinically-relevant difference in preference" and determined if images were "diagnostic."
8. Sample Size for Training Set
- The document does not specify the sample size used for the training set of the AiCE Reconstruction Processing Unit for MR. This submission is an extension of the maximum acceleration factor, and the AiCE unit itself was part of a previous clearance (K203323).
9. How Ground Truth for Training Set Was Established
- The document does not provide information on how the ground truth for the training set of the AiCE Reconstruction Processing Unit was established.
§ 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.