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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.

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.

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Vantage Fortian 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) is a 1.5 Tesla Magnetic Resonance Imaging (MRI) System. The Vantage Fortian uses 1.4 m short and 4.1 tons light weight magnet. It includes the Canon Pianissimo™ Σ and Pianissimo Zen technology (scan noise reduction technology). The design of the gradient coil and the whole body coil of the Vantage Fortian provides the maximum field of view of 55 x 55 x 50 cm. The Model MRT-1550/ WK, WM, WO, WQ 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 Fortian MRI System is comparable to the current 1.5T Vantage Orian MRI System (K211633), cleared July 22, 2021 with the following modifications.

The provided text describes a 510(k) premarket notification for a new MRI system, the Vantage Fortian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR. This submission seeks to demonstrate substantial equivalence to a previously cleared predicate device.

The document primarily focuses on changes to hardware and software features of the MRI system and the safety and performance testing conducted for these changes. It does not contain information about a study proving the device meets acceptance criteria for an AI-specific application in the manner typically expected for a diagnostic AI device (e.g., a multi-reader, multi-case study comparing human performance with and without AI assistance).

Instead, the information provided for the AI-related features (pCASL, mART EXP, IMC, RDC DWI, sureVOI Liver, LiverLine+, ProstateLine+, W-SpineLine+) focuses on their functional validation and improvement of image quality/workflow, rather than a comparative diagnostic performance study with human readers.

However, based on the information provided regarding the evaluation of the new software features, here's an attempt to answer the questions within the given constraints.

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of quantitative acceptance criteria for each software feature in the format of "metric > threshold" along with a "reported performance" value. Instead, it describes qualitative or general statements of acceptance.

2. Sample sizes used for the test set and the data provenance

• Sample Size:
  • SureVOI Liver, LiverLine+, ProstateLine+, W-SpineLine+: "volunteer images" (specific number not provided).
  • Exsper in FSE2D: "phantom images" (specific number not provided).
  • mART EXP: "phantom images" (specific number not provided).
  • IMC: "volunteer images" (specific number not provided).
  • RDC DWI: "phantom images" (specific number not provided).
  • pCASL: "phantom images" (specific number not provided).
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The use of "volunteer images" for some tests implies prospective acquisition, but details are not given.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document does not mention the use of experts to establish a "ground truth" for the test set in the context of diagnostic performance evaluation. The "ground truth" for these performance tests appears to be defined by the expected functional behavior and image characteristics, likely assessed by engineers and imaging scientists rather than clinical experts for diagnostic consensus.

4. Adjudication method for the test set

Not applicable. The document describes functional and image quality evaluations rather than diagnostic performance evaluations requiring adjudication of expert interpretations.

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 comparative effectiveness study involving human readers with and without AI assistance was not conducted or reported in this document. The evaluations described are primarily focused on the technical performance, artifact reduction, and workflow assistance of the new features.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, the testing described appears to be primarily standalone (algorithm only) performance, assessing the direct output of the new software features in terms of image quality, artifact reduction, or automated functionality (e.g., sureVOI Liver, LiverLine+). Human assessment of the "diagnostic quality" of images produced by these features is mentioned, but it's not a formal diagnostic performance study.

7. The type of ground truth used

The "ground truth" used for these tests appears to be:

• Pre-determined functional expectations/specifications: For features like sureVOI Liver, LiverLine+, ProstateLine+, W-SpineLine+, the confirmation that they "worked as intended" and "met predetermined acceptance criteria" suggests this.
• Comparison to existing methods/undesirable conditions: For Exsper (reduces unfolding errors compared to traditional SPEEDER), mART EXP (reduces distortion more than mART+), IMC (effective in reducing motion artifacts), and RDC DWI (reduces distortion compared to conventional images).
• Quantitative measurements against expected values: For pCASL, "CBF values via pCASL met predetermined acceptance criteria" implies quantitative comparison to established values or ranges.

8. The sample size for the training set

The document does not provide information on the sample size of the training set used for the AI-related features (e.g., LiverLine+, ProstateLine+, W-SpineLine+). These are described as "Machine Learning based detection technology," implying a training phase, but details are not given.

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 (if applicable to features like LiverLine+ which use machine learning) was established.

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