(116 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 3.8 tons light weight magnet. It includes the Pianissimo™ technology (scan noise reduction technology). The design of the gradient coil and the WB coil of the Vantage Orian 1.5T provides the maximum field of view of 55 x 50 cm. The Model MRT-1550/AC, AD, AG, AH includes the standard gradient system and Model MRT-1550/AK, AL, AO, AP includes the XGO gradient system. The AiCE Reconstruction Processing Unit for MR is included with this system for the processing of images for various anatomical regions.
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 3ºº, 2020.
Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:
The document describes a 510(k) premarket notification for the "Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MR." The primary focus of this submission is the addition of anatomical regions to the cleared AiCE (Artificial intelligence-based Clear Engine) Deep Learning Reconstruction technology, with no changes to the underlying software or hardware.
Therefore, the acceptance criteria and study data provided mostly relate to demonstrating that the AiCE Deep Learning Reconstruction, when applied to these new anatomical regions, maintains or improves image quality compared to existing methods.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a formal "acceptance criteria" table with specific numerical targets. Instead, it describes general goals for AiCE's performance relative to other filters and a predicate device.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Maintain or improve image low contrast detectability | AiCE deep learning reconstruction underwent performance (bench testing) using a model observer study to determine that image low contrast detectability was maintained or improved. |
| Maintain or improve SNR and contrast performance | Accompanied with other bench testing of SNR and contrast performance. (Implicitly, these were maintained or improved, but specific results are not provided). |
| Demonstrate equal or superior performance compared to rival filters (human perception) | A human observer study was conducted with 6 board-certified radiologists and 55 studies that demonstrated a statistical preference of AiCE when compared to other performance filters. The results demonstrated that AiCE performed either at the same level or above the performance of the commercially available predicate device. |
| Safety and effectiveness for expanded anatomical regions | Bench testing and volunteer clinical imaging additionally conducted does not change the conclusion that the subject device is safe and effective for its intended use (expanded anatomical regions). |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: 55 studies (for the human observer study).
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). It mentions "volunteer clinical imaging," suggesting prospective data acquisition, but this is not fully confirmed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: 6 board-certified radiologists.
- Qualifications: "Board certified radiologists." No specific years of experience are mentioned.
4. Adjudication Method for the Test Set
The document does not explicitly mention an adjudication method (such as 2+1 or 3+1 consensus). It states that the human observer study demonstrated a "statistical preference of AiCE when compared to other performance filters," which implies individual reader assessments were used and then analyzed statistically. It does not describe how disagreements, if any, were resolved to establish a single ground truth from the radiologists' readings.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
Yes, a multi-reader, multi-case (MRMC) comparative effectiveness study was done.
- Effect Size of Human Readers Improve with AI vs. Without AI Assistance: The document states that the study "demonstrated a statistical preference of AiCE when compared to other performance filters" and that AiCE performed "either at the same level or above the performance of the commercially available predicate device." However, a specific effect size or quantitative measure of improvement for human readers with AI assistance is not provided. It only indicates a preference and equivalent/superior performance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, a standalone performance assessment (bench testing) was done.
- Performance: A "model observer study" was used to determine that image low contrast detectability was "maintained or improved." Additionally, "other bench testing of SNR and contrast performance" was conducted. Specific quantitative results (e.g., exact SNR values, contrast ratios) for these standalone assessments are not provided.
7. The Type of Ground Truth Used
For the model observer study and bench testing, the ground truth would likely be simulated data or objective phantom measurements for low contrast detectability, SNR, and contrast. For the human observer study, the "ground truth" implicitly relies on the expert judgment/preference of the 6 board-certified radiologists when comparing images, rather than a definitive pathological or outcomes-based ground truth. Since the study's objective was to demonstrate preference and equivalent/superior performance relative to other filters, the radiologists' comparative assessment served as the evaluative benchmark.
8. The Sample Size for the Training Set
The document does not provide information on the sample size used for the training set for the AiCE Deep Learning Reconstruction.
9. How the Ground Truth for the Training Set Was Established
The document does not provide information on how the ground truth for the training set was established for the AiCE Deep Learning Reconstruction. This information is typically proprietary to the manufacturer and not always detailed in 510(k) summaries for modifications that don't alter the core algorithm.
§ 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.