(74 days)
Vantage Galan 3T systems are indicated for use as a diagnostic imaging modality that produces crosssectional 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-3020) is a 3 Tesla Magnetic Resonance Imaging (MRI) System, previously cleared under K212056. 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 provided text describes a 510(k) submission for the Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MR. This submission primarily focuses on software and accessory changes to an already cleared device. Due to the nature of a 510(k) summary, detailed acceptance criteria and in-depth study results are not fully elaborated in the provided document, as it emphasizes substantial equivalence to a predicate device.
However, I can extract the information that is present and highlight what is not explicitly detailed, based on the structure of your request.
Here's a breakdown of the acceptance criteria and study information provided in the document:
1. Table of Acceptance Criteria and Reported Device Performance
The document broadly states that "the test results met predetermined acceptance criteria" for various features. However, it does not provide a specific table or quantified acceptance criteria values, nor does it give specific numerical performance metrics for these criteria. The performance is described qualitatively.
| Feature/Functionality | Acceptance Criteria (Not Quantified) | Reported Device Performance (Qualitative) |
|---|---|---|
| sureVOI Liver, LiverLine+, ProstateLine+, W-SpineLine+ | "worked as intended", "images were of diagnostic quality", "test results met predetermined acceptance criteria" | Confirmed that these features worked as intended, the images were of diagnostic quality. |
| Exsper in FSE2D | "reduces artifacts caused by unfolding errors, compared to traditional SPEEDER" | Confirmed that Exsper reduces artifacts caused by unfolding errors, compared to traditional SPEEDER. Functionality testing in FE2D and SE2D confirmed scanning without problems. |
| 2D-RMC in FSE2D and FASE2D | "scanning... can be conducted without problems" | Confirmed that the scanning in those sequences can be conducted without problems. |
| mART EXP | "reduce distortion artifacts" | Testing verified mART EXP can reduce distortion artifacts in the readout direction like mART+ and can also reduce distortion artifacts in the slice direction more than mART+. |
| IMC (Iterative Motion Correction) | "effective in reducing motion artifacts" | Testing confirmed that IMC is effective in reducing motion artifacts for head (rigid motion) and C-spine (rigid and non-rigid motion). |
| RDC DWI | "distortion... reduced" | Confirmed that the distortion in phase encoding direction was reduced by RDC DWI as compared to conventional images without RDC DWI in SEEPI2D sequence. |
| pCASL (pseudo-continuous ASL) | "CBF values... met predetermined acceptance criteria" | Testing confirmed CBF values via pCASL met predetermined acceptance criteria. |
| Ceiling Camera | "percentage of successful patient orientation detection and cases requiring no correction for successful patient anatomy position detection met predetermined acceptance criteria" | Confirmed that percentage of successful patient orientation detection and cases requiring no correction for successful patient anatomy position detection met predetermined acceptance criteria. These percentages are not specified. |
2. Sample Sizes Used for the Test Set and Data Provenance
- Sample Sizes: The document states that "sureVOI Liver, LiverLine+, ProstateLine+, and W-SpineLine+ were evaluated using volunteer images," "IMC (Iterative Motion Correction) for head and C-spine was evaluated using volunteer images," and "pCASL (pseudo-continuous ASL) was evaluated utilizing volunteer images." The Ceiling Camera function was evaluated using volunteers. No specific number of volunteers or images is provided. Phantom images were used for Exsper and RDC DWI.
- Data Provenance: The document implies these studies were conducted by Canon Medical Systems Corporation in Japan, as it lists their manufacturing site and official correspondent there. The patient data origin (country) is not specified. It can be inferred that the data is prospective given the use of "volunteer images" for testing certain features.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document does not specify the number of experts used or their qualifications for establishing ground truth for the test sets. It mentions that images are "interpreted by a trained physician" as part of the overall indications for use, but this is a general statement, not specific to the validation study.
4. Adjudication Method for the Test Set
The document does not specify an adjudication method (such as 2+1, 3+1, or none) for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with AI assistance vs. without AI assistance, nor does it specify an effect size for such a study. The functionalities described are primarily about improving image quality, reducing artifacts, or automating scan planning, rather than direct diagnostic AI assistance for human readers in a comparative effectiveness study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
The document describes several software features that perform automated tasks (e.g., sureVOI Liver, LiverLine+, ProstateLine+, W-SpineLine+ for auto-detection and scan planning; IMC, RDC DWI, Exsper for image reconstruction/artifact reduction). These functions effectively demonstrate "algorithm-only" performance in their specific tasks without explicit human-in-the-loop evaluation being described in the validation section. For instance, the acceptance of automatic detection and planning functions implies a standalone evaluation of the algorithm's ability to identify relevant anatomical regions.
7. The Type of Ground Truth Used
The document implies the following types of ground truth:
- For automated scan planning features (sureVOI Liver, LiverLine+, ProstateLine+, W-SpineLine+): The ground truth seems to be derived from expert-confirmed correct anatomic localization and scan planning, as the outcome measure is whether the features "worked as intended" and "images were of diagnostic quality." This implicitly means agreement with human-expert derived optimal scan planes.
- For image quality/artifact reduction features (Exsper, mART EXP, IMC, RDC DWI): The ground truth relates to the absence or reduction of artifacts and the diagnostic quality of the resulting images. This would likely be assessed by expert review and comparison to images without the feature, or a recognized "ground truth" image.
- For pCASL: "CBF values via pCASL met predetermined acceptance criteria." This suggests a quantitative ground truth for Cerebral Blood Flow (CBF) values, possibly established through established methods or phantom measurements.
- For Ceiling Camera: "percentage of successful patient orientation detection and cases requiring no correction for successful patient anatomy position detection met predetermined acceptance criteria." This suggests a ground truth for correct patient orientation and anatomy position, likely established by human observation or measurement.
8. The Sample Size for the Training Set
The document does not provide specific details about the sample size used for the training set (if any) for the machine learning-based features (LiverLine+, ProstateLine+, W-SpineLine+). As this is a 510(k) for a modification, the focus is on validation of the changes rather than a full de novo submission of an AI algorithm, so training data details are often omitted if not directly relevant to the new functionality's validation.
9. How the Ground Truth for the Training Set was Established
The document does not provide details on how ground truth was established for any training data used for the machine learning-based features.
§ 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.