(47 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 4.1 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/A3, A4, A7, A8 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 (K193021), cleared June 3, 2020 with the following modifications.
The provided document is a 510(k) summary for the Vantage Orian 1.5T, MRT-1550, V6.0 MRI System. This submission is for modifications to an already cleared device (K193021) and primarily focuses on safety and performance parameters typical for an MRI system, rather than AI/algorithm-driven diagnostic performance.
The document states:
- "No change from the previous predicate submission, K193021." regarding "IMAGING PERFORMANCE PARAMETERS".
- "image quality testing was completed which demonstrated that the subject device meets predetermined acceptance criteria. Image quality metrics were performed to assess signal-to-noise ratio, two-dimensional geometric distortion, image uniformity, and slice thickness."
Therefore, the acceptance criteria and study detailed below relate to physical device performance and image quality, not an AI algorithm's diagnostic accuracy or effectiveness in clinical interpretation. Since this is an MRI system and not an AI-powered diagnostic device, many of the requested elements for AI/algorithm studies (like sample size for test sets and training sets, AI effect size on human readers, adjudication methods, number of experts for ground truth, etc.) are not applicable in the context of this 510(k) submission.
Here is the information directly applicable from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Measured Metric) | Reported Device Performance (Summary) |
|---|---|
| Signal-to-noise ratio (SNR) | Meets predetermined acceptance criteria (exact values not provided in this summary) |
| Two-dimensional geometric distortion | Meets predetermined acceptance criteria (exact values not provided in this summary) |
| Image uniformity | Meets predetermined acceptance criteria (exact values not provided in this summary) |
| Slice thickness | Meets predetermined acceptance criteria (exact values not provided in this summary) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of patient data or clinical images for evaluating diagnostic performance. The tests described are "bench testing" and "image quality testing." These likely refer to tests conducted on phantoms or test objects, not human patient data. Therefore, details like data provenance or sample size of patient cases are not provided as they are not relevant to the type of testing performed for this device modification.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. The "ground truth" here would relate to physical image quality measurements from phantoms or engineering specifications, not expert diagnostic consensus on patient images.
4. Adjudication Method
Not applicable. No expert adjudication process is described for the image quality testing details provided.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not performed/Not applicable. This is a 510(k) for an MRI system modification, not an AI diagnostic algorithm. The document makes no mention of studies involving human readers or AI assistance.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This is a medical device (MRI system), not an AI algorithm. The performance evaluation is for the system's ability to acquire images, not interpret them.
7. Type of Ground Truth Used
The ground truth for the image quality testing would be based on physical phantom measurements and engineering specifications for parameters like SNR, geometric distortion, uniformity, and slice thickness.
8. Sample Size for the Training Set
Not applicable. This is a hardware modification submission for an MRI system, not an AI algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there's no AI algorithm training set, there's no ground truth established for it.
§ 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.