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Viz AAA is a radiological computer-assisted triage and notification software device for analysis of CTA images of the abdomen. The device is intended to assist hospital networks and vascular specialists in workflow triage by flagging and prioritizing studies with suspected abdominal aortic aneurysms during routine patient care.

Viz AAA uses an artificial intelligence algorithm to analyze images and highlight studies with suspected abdominal aortic aneurysms in a standalone application for study list prioritization or triage in parallel to ongoing standard of care. The device generates compressed preview images that are meant for informational purposes only and not intended for diagnostic use. The device does not alter the original medical image and is not intended to be used as a diagnostic device.

Analyzed images are available for review through the standalone application. When viewed through the standalone application the images are for informational purposes only and not for diagnostic use. The results of Viz AAA, in conjunction with other clinical information and professional judgment, are to be used to assist with triage/prioritization of medical images. Vascular specialists who read the original medical images are responsible for the diagnostic decision. Viz AAA is limited to analysis of imaging data and should not be used inlieu of full patient evaluation or relied upon to make or confirm diagnosis.

Viz AAA is limited to detecting aneurysms at least 3 cm in diameter. Viz AAA is intended to identify infra-renal, fusiform abdominal aortic aneurysms.

Viz AAA is a radiological computer-assisted triage and notification software device for analysis of CTA images of the abdomen. The software automatically receives and analyzes CT angiogram (CTA) imaging of the abdomen for the presence of an aortic aneurysm using an artificial intelligence algorithm and highlights suspect patient imaging in a standalone application for study list prioritization or triage by vascular or endovascular specialists in parallel to standard of care image interpretation.

Viz AAA is a combination of software modules that consists of an image analysis software algorithm and mobile application software module. The Viz AAA Image Analysis Algorithm is an artificial intelligence machine learning (Al/ML) software algorithm that analyzes CTA images of the abdomen for an aortic aneurysm. Images acquired during patient care are forwarded to Viz.ai's Backend server where they are analyzed by the Viz AAA artificial intelligence algorithm for an abdominal aortic aneurysm.

Viz AAA includes a mobile software module that enables the end user to view cases identified by the Viz AAA algorithm to contain a suspected abdominal aortic aneurysm. The Viz AAA mobile software module is implemented into Viz.ai's generic non-diagnostic DICOM image mobile viewing application, Viz VIEW, which displays CTA scans that are sent to the Backend server. When the Viz AAA Mobile Software module is enabled, studies determined by the algorithm to contain a suspected abdominal aortic aneurysm are highlighted in the standalone mobile application for study list prioritization or triage in parallel to ongoing standard of care. The user can also view compressed preview images and a non-diagnostic preview of the analyzed CTA scan of the patient through the mobile application.

The preview images and additional patient imaging available through the standalone mobile application are meant for informational purposes only and not intended for diagnostic use. The results of Viz AAA, in conjunction with other clinical information and professional judgment, are to be used to assist with triage/prioritization of medical images. Vascular or endovascular specialists who read the original medical images are responsible for the diagnostic decision.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance Study for Viz AAA

The Viz AAA device is a radiological computer-assisted triage and notification software intended to assist in workflow triage by flagging and prioritizing studies with suspected abdominal aortic aneurysms (AAAs) during routine patient care. Importantly, the device is for triage and prioritization only and not for diagnostic use.

1. Table of Acceptance Criteria and Reported Device Performance

The core performance goals for Viz AAA were for its sensitivity and specificity in detecting AAAs.

The study successfully met or exceeded all pre-specified performance goals.

2. Sample Size and Data Provenance

• Test Set Sample Size: 466 CTA scans.
  • 167 scans with abdominal aortic aneurysm (positive cases)
  • 299 scans without abdominal aortic aneurysm (negative cases)
• Data Provenance: The CTA scans were obtained from two clinical sites in the U.S. The data appears to be retrospective, as it refers to "scans were obtained" and "included in the analysis," implying pre-existing data used for verification.

3. Number and Qualifications of Experts for Ground Truth

• Number of Experts: Not explicitly stated, but implied to be multiple radiologists, as "trained radiologists" is plural.
• Qualifications of Experts: Trained radiologists with fellowship in vascular radiology.

4. Adjudication Method for the Test Set

The adjudication method used to establish ground truth is not explicitly detailed in the provided text (e.g., 2+1, 3+1). It simply states that ground truth was "established by trained radiologists with fellowship in vascular radiology."

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

• Was an MRMC study done? The provided text does not indicate that an MRMC comparative effectiveness study was performed. The performance evaluation focuses solely on the standalone algorithm's accuracy (sensitivity, specificity, AUC) against expert-established ground truth.
• Effect Size: N/A (as no MRMC study information is provided).

6. Standalone Performance Study

• Was a standalone study done? Yes, a standalone performance study was conducted. The reported sensitivity, specificity, and AUC values directly reflect the algorithm's performance without human intervention in the loop for the performance evaluation.

7. Type of Ground Truth Used

• Type of Ground Truth: Expert Consensus (established by trained radiologists with fellowship in vascular radiology). The text relies on this expert review of the CTA scans to determine the presence or absence of an AAA, which serves as the ground truth against which the device's output is compared.

8. Sample Size for the Training Set

The provided text does not include information about the sample size used for the training set. It only details the performance evaluation on a test set.

9. How Ground Truth for the Training Set was Established

The provided text does not include information on how the ground truth for the training set was established. It only details the ground truth establishment for the test set.

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