(60 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
- Flow dynamics
- Chemical Shift
·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-3020) is a 3 Tesla Magnetic Resonance Imaging (MRI) System, previously cleared under K192574. 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.
Here's an analysis of the acceptance criteria and supporting study details based on the provided FDA 510(k) summary:
Analysis of Acceptance Criteria and Proving Study
The submission focuses on software changes and the substantial equivalence of the new device (Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MR) to its predicate (Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR). The primary objective of the testing described is to demonstrate that the image quality and safety of the new software functionalities are maintained and are of diagnostic quality.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance | Comments / Supporting Evidence |
|---|---|---|---|
| Safety Parameters | Static field strength | 3T | Same as predicate. |
| Operational Modes | Normal and 1st Operating Mode | Same as predicate. | |
| Safety parameter display (SAR, dB/dt) | SAR, dB/dt | Same as predicate. | |
| Operating mode access requirements | Allows screen access to 1st level operating mode | Same as predicate. | |
| Maximum SAR | 4W/kg for whole body (1st operating mode specified in IEC 60601-2-33: 2010+A1:2013+A2:2015) | Same as predicate. | |
| Maximum dB/dt | 1st operating mode specified in IEC 60601-2-33: 2010+A1:2013+A2:2015 | Same as predicate. | |
| Potential emergency condition and means provided for shutdown | Shutdown by Emergency Ramp Down Unit for collision hazard for ferromagnetic objects | Same as predicate. | |
| Imaging Performance | Overall image noise | Maintained diagnostic quality | Representative volunteer images reviewed by experts. |
| Image sharpness | Maintained diagnostic quality | Representative volunteer images reviewed by experts. | |
| Image degradation | Absence of significant degradation | Representative volunteer images reviewed by experts. | |
| Image artifacts | Absence of significant artifacts | Representative volunteer images reviewed by experts. | |
| Diagnostic contrast | Maintained diagnostic quality | Representative volunteer images reviewed by experts. | |
| Lesion/pathology conspicuity | Maintained diagnostic quality | Representative volunteer images reviewed by experts. | |
| Clinical utility | Images confirmed to be of diagnostic quality. | Representative volunteer images reviewed by experts. |
Note: The document explicitly states "No change from the previous predicate submission, K192574" for Imaging Performance Parameters on page 6. However, the subsequent "TESTING" section (Page 7) describes objective image quality assessment for the new software functionalities (3D FAST sequences and 3D Compressed SPEEDER acceleration sequences) using expert review to demonstrate that diagnostic quality is maintained. This implies that the standard for image quality (diagnostic utility) serves as the implicit acceptance criterion.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document mentions "volunteer images" and "representative images" were used. It does not explicitly state the numerical sample size (number of volunteers or images) for the image quality testing.
- Data Provenance: The document does not specify the country of origin. The study appears to be prospective in the sense that the images were acquired using the subject device specifically for this evaluation using volunteers.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: The document states "American Board Certified Radiologists and American Board Certified Cardiologists with MR certification" were used. It does not specify the exact number of such experts.
- Qualifications of Experts:
- American Board Certified Radiologists
- American Board Certified Cardiologists with MR certification
- No information on their years of experience is provided.
4. Adjudication Method for the Test Set
The document does not explicitly state an adjudication method (like 2+1, 3+1). It describes "Reviewers provided detailed assessments," suggesting individual reviews contributed to the confirmation of diagnostic quality. It does not mention whether multiple reviewers were involved in assessing the same images and how disagreements were resolved.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no indication that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was performed to assess how much human readers improve with AI vs. without AI assistance. The study described focuses on confirming the diagnostic quality of images produced by the device with new software features, not on the impact of AI assistance on human reader performance. The "AiCE Reconstruction Processing Unit" is part of the core device functionality being assessed, not an AI assist to human interpretation in this context.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The study described is an assessment of the image quality produced by the device, which includes the AiCE Reconstruction Processing Unit. The expert review confirms the diagnostic quality of these images. This is an evaluation of the algorithm's output, but it's not a standalone diagnostic performance study in the sense of the algorithm making an independent diagnosis. The device generates images to be interpreted by a trained physician. The study confirms the output (images) is of diagnostic quality, which could be considered a form of standalone performance for the image reconstruction aspect.
7. Type of Ground Truth Used
The ground truth used for evaluating image quality appears to be expert consensus/opinion regarding "diagnostic quality," "overall image noise," "image sharpness," "image degradation," "image artifacts," "diagnostic contrast," and "lesion/pathology conspicuity." This is derived from the subjective and objective assessment of the images by the certified radiologists and cardiologists. There is no mention of pathology findings or long-term outcomes data being used as ground truth for this particular study.
8. Sample Size for the Training Set
The document does not provide any information regarding the sample size for the training set used for the AiCE (Artificial intelligence-enhanced Reconstruction) component of the device. This information is typically found in the development or validation sections of the submission, but not in this summary.
9. How the Ground Truth for the Training Set Was Established
The document does not provide any information on how the ground truth for the training set for the AiCE component 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.