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The iTFlow software will be utilized in situation of blood flow in a heart and its major vessels are required for a cardiac diagnosis. iTFlow allows for the viewing, post-processing, and the quantion of cardiovascular MRI data (in DIRECTOR-compliant format) It enables:

• The import of DICOM-compliant MR Images.

• The support of a clinical diagnosis by the quantitative analysis of the imported images.

• Quantitative measurement of the size, area, blood flow, volume and mass of the heart vessels.

-Advanced correction options such as offset correction, background phase correction, and anti-aliasing.

-Data visualization as a graph or output as an image or numerical data.

iTFlow software will assist clinicians with proper training in cardiac treatment decision making a conclusive diagnosis for patients. It is intended to analyze cardiovascular MRI image data, that are acquired via electrocardiogram gated acquisition, gradient echo cine sequence, and phase contrast time-resolved multi-slice sequence, without any-contrast medium for MR angiography. Patient populations are not restricted.

iTFlow is a post-processing analysis software device for viewing and quantifying cardiovascular MR images (4D Flow MRI). The device is intended to visualize and quantify MRI data imported in DICOM format. The software has features for loading, saving, generating screen displays, and aggregating quantitative data from cardiovascular images acquired from magnetic resonance (MR) scanners. iTFlow is intended for use in both pediatric (neonate, infant, child, and adolescent) and adult populations.

The following visualization, quantification and data-reporting functionalities are provided by the software:

Visualization:

• 2D image review
• 3D image review by means of volume rendering
• Multi-planar reconstruction (MPR) views (axial, coronal and sagittal)
• Blood flow visualization using vectors, Cine play
• Streamlines, and pathlines
• Visualization of segmented region.

Quantification:

• Anatomy segmentation.
• Linear distance measurements.
• Flow rate at user-specified locations (e.g., aorta, aortic valve, pulmonary valve, mitral valve, tricuspid valve, and superior vena cava).
• Volume of segmented area and volume related parameters include stroke volume, ejection fraction, cardiac output, end-diastolic volume, end-systolic volume.

Data reporting:

• Visualized image and quantified value can be exported into a report in DICOM format.

The provided text describes the iTFlow device, a software for viewing and quantifying cardiovascular MR images (4D Flow MRI). However, it does not include a detailed study with acceptance criteria and reported device performance for a clinical evaluation.

Instead, it mentions a "Numerical phantom test result" which is a comparison to computer simulations, not a clinical study with human subjects.

Here's a breakdown of the information that is available based on your request, and where the information is missing:

1. Table of acceptance criteria and the reported device performance:

This information is not provided in the document. The numerical phantom test mentions an "underestimation in small vessels" but doesn't quantify this against acceptance criteria.

2. Sample size used for the test set and the data provenance:

• Test set sample size: Not applicable as a clinical test set with human data is not described. The "Numerical phantom test" used a "virtual aortic geometry."
• Data provenance: "virtual aortic geometry" for the numerical phantom test. No information on country of origin or whether it was retrospective/prospective for a clinical test.

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

• Number of experts: Not applicable. The ground truth for the numerical phantom test was established by "numerical flow analysis performed using OpenFOAM."
• Qualifications of experts: Not applicable.

4. Adjudication method for the test set:

Not applicable, as a clinical test set with human data and expert adjudication is not described.

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, a multi-reader multi-case (MRMC) comparative effectiveness study is not described in the document. The document focuses on the software's performance against computer simulations.

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

The "Numerical phantom test" can be considered a standalone evaluation of the algorithm's performance against simulated ground truth. The device "found no difference in flow visualization between iTFlow and CFD (computational fluid dynamics), but the flow rate in small vessels were underestimated in iTFlow due to the filter used to integrate the flow velocity."

7. The type of ground truth used:

For the "Numerical phantom test," the ground truth was established by computational fluid dynamics (CFD) using OpenFOAM.

8. The sample size for the training set:

Not provided. The document does not describe a training set or how the algorithm was developed.

9. How the ground truth for the training set was established:

Not provided. The document does not describe a training set or its ground truth establishment.

In summary, the provided document describes a validation approach using a numerical phantom test, comparing the iTFlow software's output to computational fluid dynamics simulations. It does not detail a clinical study with human patients, expert-established ground truths, or quantitative metrics against acceptance criteria that are typically found in rigorous clinical performance evaluations for medical devices.

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