(57 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, 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 cm and include the standard gradient system.
The Vantage Orian (Model MRT-1550/ UC, 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 MRI System (K213305), cleared December 1, 2021 with the following modifications.
The provided text discusses changes to the Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR and cites testing related to these changes. However, it does not provide a detailed study with specific acceptance criteria, reported performance, or comprehensive methodology (like sample sizes, ground truth establishment, or expert qualifications) that would typically be found in a standalone clinical validation study for an AI-powered device.
The document states that the submission is for "Modification of a cleared device" (K213305) and discusses "Risk Management activities for new software functionalities and pulse sequences." The testing mentioned is primarily verification and validation of these new features, confirming their intended function and not a full clinical efficacy study with specific performance metrics against a defined standard of care.
Here's an attempt to extract and describe what is available regarding acceptance criteria and studies, while highlighting the missing information based on your request:
Acceptance Criteria and Device Performance Study for Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR
The document describes a 510(k) submission for modifications to an existing MRI system. The primary testing mentioned focuses on verification of new software functionalities: Iterative Motion Correction (IMC) and a Ceiling Camera feature.
1. Table of Acceptance Criteria and Reported Device Performance
The document provides very limited, high-level information regarding acceptance criteria and performance for the newly added features. It does not present a table with specific quantitative acceptance criteria or detailed performance metrics against those criteria for the diagnostic capability of the MRI system as a whole, or even for the specific features in a clinical context.
| Feature Tested | Acceptance Criteria (as described) | Reported Device Performance (as described) |
|---|---|---|
| Iterative Motion Correction (IMC) | "Testing confirmed that IMC may reduce motion artifacts." (Implicitly, IMC should reduce motion artifacts.) | "Testing confirmed that IMC may reduce motion artifacts." The statement confirms the intended function but does not provide quantitative metrics (e.g., percentage reduction in artifacts, image quality scores). |
| Ceiling Camera (Patient Orientation Detection Function) | "percentage of successful patient orientation detection... met predetermined acceptance criteria." | "It was confirmed that percentage of successful patient orientation detection... met predetermined acceptance criteria." No specific percentage or definition of "successful" is provided. |
| Ceiling Camera (Patient Anatomy Position Detection Function) | "cases requiring no correction for successful patient anatomy position detection met predetermined acceptance criteria." | "It was confirmed that... cases requiring no correction for successful patient anatomy position detection met predetermined acceptance criteria." No specific percentage or definition of "no correction" or "successful" is provided. |
Important Note: The document explicitly states: "No change from the previous predicate submission, K213305" for Imaging Performance Parameters. This suggests that the core diagnostic imaging performance of the MRI system, including any benefits from AiCE reconstruction, was established in the predicate device's clearance and is not re-evaluated with new acceptance criteria in this submission. This current submission focuses on modifications.
2. Sample Size Used for the Test Set and Data Provenance
- Iterative Motion Correction (IMC): "volunteer images."
- Sample Size: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).
- Ceiling Camera: "volunteers."
- Sample Size: Not specified.
- Data Provenance: Not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Not specified. The testing described appears to be technical verification and validation rather than expert-reviewed clinical evaluation.
4. Adjudication Method for the Test Set
- Not specified. Given the nature of the described testing (technical confirmation of functionality rather than diagnostic performance against clinical ground truth), a formal adjudication method by experts is not mentioned or implied.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC study is not described in this document. The document states that the imaging performance parameters for the device are "No change from the previous predicate submission, K213305." This implies that any studies relevant to diagnostic performance or improvements with AiCE would have been conducted and documented for the predicate device. This submission focuses on software and accessory changes.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The testing described for IMC and the Ceiling Camera appears to be a form of standalone verification of the algorithm's functional output (e.g., reduction of motion artifacts, correct detection of patient position). However, no specific "standalone" performance metrics in a clinical diagnostic context (e.g., sensitivity, specificity for a particular pathology) are presented. The "AiCE Reconstruction Processing Unit" itself likely has standalone performance aspects, but these are not detailed in this document, as it refers back to the predicate device for imaging performance.
7. The Type of Ground Truth Used
- Iterative Motion Correction (IMC): The "ground truth" seems to be the visual assessment of "motion artifacts" in volunteer images. This is an implicit evaluation of image quality rather than a clinical truth like pathology.
- Ceiling Camera: The "ground truth" for patient orientation and anatomy position detection would be the actual patient orientation and anatomy position, likely determined by direct observation or other measurement methods during the volunteer testing, to confirm the accuracy of the camera's detection.
8. The Sample Size for the Training Set
- Not specified. The document describes changes to an existing system, including "Iterative Motion Correction (IMC)" which is a software functionality for MRI. While AI-based reconstructions like "AiCE" (which is part of the system name) typically involve significant training data, this document does not provide details on the training set for AiCE or for the new IMC feature. The focus is on the modified device and its changed components.
9. How the Ground Truth for the Training Set was Established
- Not specified. As the training set size and details are not provided, neither is information on how its ground truth 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.