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CereFlow™ V1.2 is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard "off-the-shelf" workstation and can be used to perform image viewing, processing, image collage and analysis of medical images. Data and images are acquired through DICOM compliant imaging devices and modalities.

CereFlow™ V1.2 provides visualization and automatic semi-quantification of Arterial Spin Labeling (ASL) data acquired from Magnetic Resonance Imaging (MRI) scanners at 1.5T and 3.0T.

CereFlow™ V1.2 is able to process single-delay and multi-delay ASL data to quantify multiple perfusion parameters (Cerebral Blood Flow/CBF, Arterial Transit Time/ATT), and exports the results of ASL image analysis as DICOM images and in a report.

CereFlow™ V1.2 is a medical viewing, analysis and processing, Medical Image Management and Processing System software implemented in Java and Java tools, compliant with the DICOM standard and running on standard PC (Windows 10 64-bit). CereFlow™ V1.2 is intended for visualization and automatic semi-quantitative quantification of arterial spin labeling (ASL) data acquired from MRI scanners at 1.5T and 3.0T. CereFlow™ V1.2 is able to process single-delay and multi-delay ASL data to generate multiple perfusion parameters (Cerebral Blood Flow/CBF, Arterial Transit Time/ATT), and exports the results of ASL image analysis as DICOM images and in a report.

The software consists of three modules, namely the interface module, and the database module. The interface module is responsible for interacting with users and helping them to manage cases easily. The report module is responsible for processing raw DICOM images and calculating parameters to generate ATT/CBF images which can be exported as DICOM images and in a report. Image pre-processing includes sorting and checking files to ensure designated protocols are used, having a complete set of reference (MO) image and label/control images, and implementing motion correction. The calculation of CBF and ATT parameters is implemented using the standard one-compartment perfusion model recommended by the consensus ASL white paper and standard nonlinear iterative curve-fitting approach for multi-delay ASL data. For single-delay ASL data, CBF is calculated according to the standard one-compartment perfusion model recommended by the ASL white paper.

The database module is responsible for managing cases including storing, query and deleting case data. The software applies an arrange of quality control parameters to ensure the quality of acquired ASL data and processed results. These quality control parameters can also be exported as a report.

The entire workflow is processed locally, and the report module shall only allow raw ASL imaging data importing from DICOM CD-R only. CereFlow™ V1.2 is not interface with DICOM servers, MR scanners, or PACS over wired network. It is a standalone software application designed to run on a dedicated PC workstation.

Here's a summary of the acceptance criteria and study information for CereFlow™ V1.2, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in a quantitative format for specific performance metrics like sensitivity, specificity, or agreement. Instead, it focuses on functional validation and comparison to a predicate device. The performance is reported in terms of successful completion of functionalities and accuracy validated against a reference.

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

• The document mentions "retrospective clinical studies were conducted to validate performance" but does not specify the sample size for these clinical studies.
• Data Provenance: The document does not explicitly state the country of origin of the data. It refers to ASL data acquired from "commercial MRI scanners at 1.5T and 3.0T" and mentions comparing performance to GE 3D ASL using "ASL data acquired via GE scanner," but geographical origin is not provided. The studies were retrospective.

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

• The document does not specify the number of experts used to establish ground truth for the test set.
• It refers to the use of a "standard one-compartment perfusion model recommended by the consensus ASL white paper" for CBF and ATT calculations, implying that an established scientific consensus (rather than ad-hoc expert ground truth) was used as the reference standard for these quantifiable parameters.
• The document does state that the software is "to be used by trained professionals including but not limited to physicians and medical technicians." This refers to the end-users of the device, not experts establishing ground truth for validation.

4. Adjudication Method for the Test Set

• The document does not describe an adjudication method for establishing ground truth, such as 2+1 or 3+1. Given the focus on quantifiable parameters based on established models and digital phantoms, a traditional expert adjudication process for image interpretation might not have been applicable in the same way it would be for diagnostic interpretation tasks.

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

• The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study regarding human readers' improvement with AI vs. without AI assistance. The study focuses on the standalone performance and accuracy of the algorithm itself.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Yes, a standalone study was performed. The document details "non-clinical testing including verification tests" and "retrospective clinical studies were conducted to validate performance of the CereFlow™ V1.2 meeting the acceptance criteria." This implies testing the algorithm's performance independent of human-in-the-loop interaction.
• It also states, "Translational MRI, LLC intends to compare the performance (i.e. quantification accuracy of CBF maps) of CereFlow™ V1.2 to the performance of GE 3D ASL at each post-labeling delay using the ASL data acquired via GE scanner." This is a direct comparison of algorithmic output to a reference algorithm.

7. Type of Ground Truth Used

• The ground truth for the quantifiable perfusion parameters (CBF, ATT) was established using:
  • "Standard one-compartment perfusion model recommended by the consensus ASL white paper": This serves as a well-established, scientifically accepted reference for calculating these parameters from ASL data.
  • Digital phantoms: Mentioned in the non-clinical testing. These typically have known, simulated ground truth values.
  • Comparison to a reference device/algorithm (GE 3D ASL): The accuracy of CBF maps was compared to GE 3D ASL, implying that the output of this established algorithm served as a reference for comparison.

8. Sample Size for the Training Set

• The document does not provide information on the sample size used for the training set.

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, as it does not discuss the training process for the algorithm. It primarily focuses on the validation of the device's calculations against established models and reference systems.

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