Search Results

Vantage Elan systems are indicated for use as a diagnostic imaging modality that produces crosssectional 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 Elan (Model MRT-2020) is a 1.5 Tesla Magnetic Resonance Imaging (MRI) System, previously cleared under K171597. This system is based upon the technology and materials of previously marketed Canon Medical Systems and is intended to acquire and display crosssectional transaxial, coronal, sagittal, and oblique images of anatomic structures of the head or body. The Vantage Elan uses 1.4m short and 4.1 ton light weight magnet. It includes the Pianissimo™ Σ technology (scan noise reduction technology). The design of the gradient coil and the whole body coil of the Vantage Elan provides the maximum field of view of 55 x 50 cm. The Model MRT-2020/A1 is without secondary cooling system and the Model MRT-2020/A2 is with secondary cooling system.

The document describes the acceptance criteria and supporting studies for the Vantage Elan 1.5T, MRT-2020, V6.0 MRI System, specifically regarding new software functionalities and sequence enhancements.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a specific table of quantitative acceptance criteria with corresponding performance metrics for each new feature. Instead, it describes general conclusions after evaluation.

Here's a summary derived from the text:

2. Sample Size Used for the Test Set and Data Provenance

The document mentions the use of "phantom and volunteer images" for the evaluation of T2 Map, WFS DIXON, and 2D-RMC. For SpineLine+, KneeLine+, surevol Knee, Quick Star, and Fast 3D mode, "volunteer images" were utilized.

• Sample Size (Test Set): Not explicitly stated with specific numbers of phantoms or volunteers.
• Data Provenance: Not specified (e.g., country of origin). The studies appear to be prospective as they were conducted for the purpose of verifying the new functionalities.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not provided in the document. The evaluations are described as "testing verified" or "it was concluded/confirmed," but there is no mention of expert involvement in establishing ground truth for the test images.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

There is no mention of an MRMC comparative effectiveness study being performed, nor any effect size information regarding human reader improvement with or without AI assistance. The document focuses on the technical performance and diagnostic quality of the new features.

6. Standalone (Algorithm Only) Performance

The document describes the evaluation of software functionalities and sequence enhancements, implying standalone performance evaluation for these features. For instance, "testing verified that water signals and fat signals are separated" for WFS DIXON and "it was concluded that T2 maps can be generated" for T2 Map using pre-contrast pulses. These statements refer to the direct output and functionality of the algorithms/sequences.

7. Type of Ground Truth Used

Based on the descriptions:

• For WFS DIXON and T2 Map: The ground truth appears to be based on the expected physical and technical outcomes (e.g., successful separation of water/fat, generation of T2 maps). This would likely involve expert evaluation of the image output against expected results, potentially using quantitative metrics.
• For 2D-RMC and other imaging features (SpineLine+, KneeLine+, etc.): The ground truth is implied to be visual assessment of diagnostic image quality and confirmation that the features "worked as intended." This would likely involve expert radiologists/technicians evaluating the images to ensure they are free of artifacts, properly positioned, and diagnostically usable. It's an expert consensus or clinical utility assessment of the generated images, rather than a comparison to a definitive pathology report or outcome data.

8. Sample Size for the Training Set

The document does not provide any information regarding the sample size for a training set. Given that these are software functionalities for an MRI system, rather than an AI-driven diagnostic algorithm, direct "training data" in the typical machine learning sense might not be explicitly used or reported in this context. The functions like SpineLine+ or KneeLine+ could use pre-programmed anatomical models or algorithms rather than statistical learning from a large, labeled dataset in the way a CAD system would.

9. How the Ground Truth for the Training Set Was Established

As no training set is mentioned (see point 8), there is no information on how its ground truth would have been established.

Ask a specific question about this device

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.

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.

Ask a specific question about this device