(28 days)
Vantage Fortian/Orian 1.5T 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 Fortian (Model MRT-1550/ WK, WM, WQ)/Vantage Orian (Model MRT-1550/ A3, A4, A7, A8) is a 1.5 Tesla Magnetic Resonance Imaging (MRI) System. These Vantage Fortian/Orian models use 1.4 m short and 4.1 tons light weight magnet. They include the Canon Pianissimo Zen technology (scan noise reduction technology). The design of the gradient coil and the whole-body coil of these Vantage Fortian/Orian models provide the maximum field of view of 55 x 55 x 50 cm and include the standard gradient system.
The Vantage Orian (Model MRT-1550/ UC, UG, UG, UH, UK, UL, UO, UP, AK, AL, AO, AP, Upgrade only: A3, A4, A7, A8, AC, AD, AG, AH) is a 1.5 Tesla Magnetic Resonance Imaging (MRI) System. The Vantage Orian models MRT-1550/ UC, UG, UH, UK, UL, UO, UP, Upgrade only: A3, A4, A7, A8 use 1.4 m short and 4.1 tons light weight magnet while the Vantage Orian models MRT-1550/ AK, AL, AO, AP, Upgrade only: AC, AD, AG, AH use 1.4 m short and 3.8 tons light weight magnet. All of the aforementioned models include the Canon Pianissimo™ and Pianissimo Zen technology (scan noise reduction technology). The design of the gradient coil and the whole-body coil of these Vantage Orian models provide the maximum field of view of 55 x 50 cm. The Model MRT-1550/ UC, UD, UG, UH, UK, UL, UO, UP, AK, AL, AO, AP includes the XGO gradient system. The Model MRT-1550/ A3, A4, A7, A8, AC, AD, AG, AH include the standard gradient system.
This system is based upon the technology and materials of previously marketed Canon Medical Systems MRI systems and is intended to acquire and display cross-sectional transaxial, coronal, sagittal, and oblique images of anatomic structures of the head or body. The Vantage Fortian/Orian MRI System is comparable to the current 1.5T Vantage Fortian/Orian MRI System (K220335), cleared April 5, 2022 with the following modifications.
This FDA 510(k) summary provides limited details regarding the acceptance criteria and the study that proves the device meets those criteria. Here's a breakdown of the information provided and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states: "Additionally, image quality testing was completed which demonstrated that the subject device meets predetermined acceptance criteria." However, it does not explicitly provide a table of these acceptance criteria or the specific reported device performance metrics against them.
The device is a Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR. The submission is a "Modification of a cleared device" (K220335), specifically an update to "Iterative Motion Correction (IMC)" for brain imaging. The primary claim is substantial equivalence to the predicate device.
What is provided:
The summary lists several "Safety Parameters" for the subject device and compares them to the predicate device, indicating they are "Same". These are not "acceptance criteria" for performance but rather safety specifications.
| Item | Subject Device: Vantage Fortian/Orian 1.5 T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR | Predicate Device: Vantage Fortian/Orian 1.5 T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR (K220335) | Notes |
|---|---|---|---|
| Static field strength | 1.5T | 1.5T | Same |
| Operational Modes | Normal and 1st Operating Mode | Normal and 1st Operating Mode | Same |
| Safety parameter display | SAR, dB/dt | SAR, dB/dt | Same |
| Operating mode access requirements | Allows screen access to 1st level operating mode | Allows screen access to 1st level operating mode | Same |
| Maximum SAR | 4W/kg for whole body (1st operating mode specified in IEC 60601-2-33: 2010+A1:2013+A2:2015) | 4W/kg for whole body (1st operating mode specified in IEC 60601-2-33: 2010+A1:2013+A2:2015) | Same |
| Maximum dB/dt | 1st operating mode specified in IEC 60601-2-33: 2010+A1:2013+A2:2015 | 1st operating mode specified in IEC 60601-2-33: 2010+A1:2013+A2:2015 | Same |
| Potential emergency condition and means provided for shutdown | Shutdown by Emergency Ramp Down Unit for collision hazard for ferromagnetic objects | Shutdown by Emergency Ramp Down Unit for collision hazard for ferromagnetic objects | Same |
The document also states: "Image quality testing was completed which demonstrated that the subject device meets predetermined acceptance criteria." However, the specific criteria (e.g., Signal-to-Noise Ratio (SNR), Contrast-to-Noise Ratio (CNR), spatial resolution, artifact levels, particularly related to motion artifact reduction for IMC) and the reported performance values against these criteria are not detailed in this summary. The critical aspect of this submission is the improvement in Iterative Motion Correction (IMC) for brain imaging, implying the acceptance criteria would relate to reduced motion artifacts and maintained/improved image quality in the presence of motion.
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "image quality testing" and "bench testing" but does not specify the sample size for the test set used for evaluating the IMC or the overall device performance. It also does not specify the data provenance (e.g., country of origin of the data, retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the given 510(k) summary. It does not mention any expert reviews for establishing ground truth. Since the modification is related to "Iterative Motion Correction (IMC)" for brain imaging, if expert evaluation was done, it would likely involve radiologists reviewing images for artifact reduction and diagnostic quality.
4. Adjudication Method for the Test Set:
This information is not provided in the given 510(k) summary.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:
The document does not mention any MRMC study or any assessment of human reader improvement with or without AI assistance. The AiCE (Advanced intelligent Clear-iq Engine) is an AI-based reconstruction processing unit, and the IMC is an update to its functionality. While the device incorporates AI, this submission focuses on demonstrating substantial equivalence and technical performance rather than clinical effectiveness with human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
The document broadly mentions "image quality testing," "bench testing," and "software validation." These types of tests are typically standalone evaluations of the algorithm's performance. However, specific details about whether this entailed a formal standalone performance study or solely technical verification and validation are not explicitly detailed. Given the technical nature of reconstruction (reducing motion artifacts), standalone performance metrics (e.g., artifact reduction ratios, quantitative image metrics) would be expected.
7. The Type of Ground Truth Used:
The document does not explicitly state the type of ground truth used for image quality testing. For motion correction algorithms, ground truth might involve:
* Simulated motion: Using phantoms or volunteer data with artificially induced and quantifiable motion.
* Expert assessment: Radiologists evaluating images for artifact presence and severity.
* Comparison to "no motion" scans: If available, comparing corrected images to baseline scans without motion.
8. The Sample Size for the Training Set:
This information is not provided in the 510(k) summary. The AiCE is an AI-based reconstruction, meaning it would have been trained on data. This submission describes an "update" to IMC within AiCE, implying the underlying AI model has been refined or retrained.
9. How the Ground Truth for the Training Set Was Established:
This information is not provided in the 510(k) summary. For AI reconstruction technologies like AiCE, ground truth for training often involves high-quality, artifact-free MRI data, potentially with synthetic degradation to train the model to remove noise and artifacts.
§ 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.