(32 days)
Vantage 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 Orian (Model MRT-1550) is a 1.5 Tesla Magnetic Resonance Imaging (MRI) System. The Vantage Orian uses 1.4 m short and 4.0 tons light weight magnet. It includes the Canon Pianissimo™ and Pianissimo Zen technology (scan noise reduction technology). The design of the gradient coil and the whole body coil of the Vantage Orian provides the maximum field of view of 55 x 50 cm. The Model MRT-1550/AS, AT, AW, AX includes 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 Orian MRI System is comparable to the current 1.5T Vantage Orian MRI System (K182282), cleared October 19, 2018 with the following modifications.
This document is a 510(k) summary for a Magnetic Resonance Diagnostic Device (MRDD), specifically the Vantage Orian 1.5T, MRT-1550, V4.5. The submission is a "Special 510(k) Premarket Notification" for a modification of a cleared device. As such, the information provided focuses on demonstrating substantial equivalence to the predicate device rather than presenting a de novo study on a novel AI algorithm.
Therefore, many of the typical acceptance criteria and study details for an AI-powered diagnostic device, such as those related to reader studies, standalone performance, and extensive ground truth establishment for a new algorithm, are NOT present in this document. The document primarily focuses on hardware modifications (reusing an older magnet type in a new system configuration) and ensuring the new configuration performs equivalently to the already cleared system.
However, based on the information provided, here's what can be extracted and inferred:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria in a table format for imaging performance. Instead, it relies on the concept of "No change from the previous predicate submission" (K182282) for imaging performance. This implies that the acceptance criterion for imaging performance is equivalent performance to the predicate device.
| Acceptance Criterion Type | Acceptance Criterion | Reported Device Performance |
|---|---|---|
| Static field strength | 1.5T (Same as predicate) | 1.5T |
| Operational Modes | Normal and 1st Operating Mode (Same as predicate) | Normal and 1st Operating Mode |
| Safety parameter display | SAR, dB/dt (Same as predicate) | SAR, dB/dt |
| Operating mode access requirements | Allows screen access to 1st level operating mode (Same as predicate) | Allows screen access to 1st level operating mode |
| 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) |
| 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 |
| Potential emergency condition and means provided for shutdown | Shutdown by Emergency Ramp Down Unit for collision hazard for ferromagnetic objects (Same as predicate) | Shutdown by Emergency Ramp Down Unit for collision hazard for ferromagnetic objects |
| Imaging Performance | No change from the previous predicate submission (K182282) | "image quality testing was completed which demonstrated that the subject device meets predetermined acceptance criteria" - Specific quantitative results are not provided in this summary. |
| Software Validation | Successful completion of software validation (per FDA guidance) | Successful completion of software validation |
| Risk Management & Design Controls | Concurrence with established medical device development standards and guidance | Applied risk management and design controls; hazard analysis performed. |
| Compliance with Standards | Compliance with listed IEC and NEMA standards. | Device designed and manufactured under QSR (21 CFR § 820) and ISO 13485 Standards, and tested in accordance with applicable recognized consensus standards. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a separate "test set" in the context of an algorithm's performance study with a specific sample size. The testing mentioned appears to be system-level verification and validation, including "bench testing" and "image quality testing."
- Sample Size: Not explicitly stated in terms of patient cases or images for performance evaluation. It refers to "image quality testing" without quantifying the number of images or patients.
- Data Provenance: Not specified. Given it's a hardware modification verification, the testing likely involved internal Canon Medical Systems data or phantoms. There is no mention of specific countries of origin or retrospective/prospective data collection for a performance study on an AI algorithm.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
Not applicable in the context of this 510(k) submission. This is a hardware modification for an MRI system, not an AI diagnostic algorithm requiring expert-established ground truth for a clinical performance study. The ground truth for MRI system performance typically involves phantom studies, engineering specifications, and established image quality metrics.
4. Adjudication Method for the Test Set
Not applicable. There's no mention of a human reader study or expert adjudication for performance assessment in this submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No. An MRMC study is not mentioned as this submission is for an MRI system hardware modification, not an AI-assisted diagnostic device.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
No. This submission does not pertain to a standalone AI algorithm.
7. The Type of Ground Truth Used
For this type of device (an MRI system), the "ground truth" for performance is established through:
- Engineering specifications and measurements (e.g., static field strength, SAR, dB/dt).
- Phantom studies for image quality (e.g., resolution, signal-to-noise ratio, uniformity).
- Compliance with recognized consensus standards (IEC, NEMA).
- Clinical images (likely for qualitative assessment, but not explicitly stated as "ground truth" from pathology or outcomes).
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML algorithm requiring a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable.
§ 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.