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FastStroke is a CT image analysis software package that assists in the analysis and visualization of CT data derived from DICOM 3.0 compliant CT scans. FastStroke is intended for the purpose of displaying vasculature of the head and neck at different time points of enhancement.
The software will assist the user by providing optimized display settings to enable fast review of the images in synchronized formats, aligning the display of the images to the order of the scans and linking together multiple groups of scans. In addition, the software fuses the vascular information from different time points into a single colorized view. This multiphase information can aid the physician in visualizing the presence or absence of collateral vessels in the brain. Collateral vessel information may aid the physician in the evaluation of stroke patients.

FastStroke is a CT image analysis software package that assists in the analysis and visualization of CT data derived from DICOM 3.0 compliant CT scans. FastStroke is intended for the purpose of displaying vasculature of the head and neck at different time points of enhancement.
The software will assist the user by providing optimized display settings to enable fast review of the images in synchronized formats, aligning the display of the images to the order of the scans and linking together multiple groups of scans. In addition, the software fuses the vascular information from different time points into a single colorized view. This multiphase information can aid the physician in visualizing the presence or absence of collateral vessels in the brain. Collateral vessel information may aid the physician in the evaluation of stroke patients.
FastStroke device has been tested with DICOM images from Discovery CT750 HD and Revolution CT using multi-phase CT Angiography. FastStroke is based on DICOM image based processing and would apply to any CT device that is able to acquire data in an equivalent multi-phase CT angiography (pursuant to the timing protocols in the user quide) manner.
FastStroke is also made available as a standalone post processing application on the AW VolumeShare workstation (K110834) and AW Server platform (K081985) that host advanced image processing applications.

Here's a breakdown of the acceptance criteria and study details for the FastStroke device based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state quantitative acceptance criteria or direct performance metrics for the FastStroke device in a table format. Instead, it describes the purpose of the study as assessing increased diagnostic capability using Likert scales and concludes that "FastStroke aids the physician in visualizing the presence or absence of collateral vessels in the brain and is a useful tool for neuroradiologists in providing a comprehensive stroke work-up."

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

• Sample Size for Test Set: The sample size for the clinical evaluation (test set) is not explicitly stated in the provided document. It only mentions "a retrospective clinical evaluation was conducted."
• Data Provenance: The study was a retrospective clinical evaluation. The country of origin of the data is not specified.

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

• Number of Experts: Three experts were used.
• Qualifications of Experts: They were described as "board certified neuroradiologists who were considered experts."

4. Adjudication Method for the Test Set

The document does not explicitly state the adjudication method used for the clinical evaluation. It only mentions that the primary endpoint was assessed by three experts using multiple 5-point Likert Scales.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly stated to be performed to measure improvement with AI vs. without AI assistance. The study described was a clinical evaluation by neuroradiologists assessing the device's aid in visualization. While it involved multiple readers, it wasn't framed as a direct comparison of human readers with and without AI assistance to quantify an "effect size" in reader performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• A standalone performance evaluation of the algorithm without human-in-the-loop was not explicitly described or quantified in the provided text as part of the clinical study. The device is described as "assisting the user" and "aiding the physician," indicating a human-in-the-loop design.

7. Type of Ground Truth Used

• The ground truth for the clinical evaluation study was established through expert consensus/interpretation by the three board-certified neuroradiologists. The study assessed the device's ability to "aid the physician in visualizing the presence or absence of collateral vessels," implying that the experts' assessment of visualization aided by the device served as the "truth" for the study's purpose.

8. Sample Size for the Training Set

• The document does not provide any information about the sample size used for the training set of the FastStroke software.

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

• The document does not provide any information on how the ground truth for the training set (if any) was established. It primarily focuses on the clinical evaluation used for substantial equivalence.

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