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EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM (EFAI AASCTA) is a radiological computer aided triage and notification software indicated for use in the analysis of chest-abdomen CTA in adults aged 22 and older. The device is intended to assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communicating suspected positive cases of aortic dissection (AD) or aortic intramural hematoma (IMH) pathology.

EFAI AASCTA uses an artificial intelligence algorithm to identify suspected findings. It makes case-level output available to a PACS/workstation for worklist prioritization or triage. EFAI AASCTA is not intended to direct attention to specific portions or anomalies of an image. Its results are not intended to be used on a stand-alone basis for clinical decisionmaking nor is it intended to rule out AAS or otherwise preclude clinical assessment of computed tomography cases.

EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM (EFAI AASCTA) is a radiological computer-assisted triage and notification software system. The software uses deep learning techniques to automatically analyze chest or chest-abdomen CTA and alerts the PACS/RIS workstation once images with features suggestive of AD or IMH are identified.

Through the use of EFAI AASCTA, a radiologist is able to review studies with features suggestive of AD or IMH earlier than in standard of care workflow.

The device is intended to provide a passive notification through the PACS/workstation to the radiologists indicating the existence of a case that may potentially benefit from the prioritization. It does not mark, highlight, or direct users' attention to a specific location on the original chest or chest-abdomen CTA. The device aims to aid in prioritization and triage of radiological medical images only.

Here's a breakdown of the acceptance criteria and study details for the EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM, based on the provided document:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: 380 CTA studies (156 positive cases, 224 negative cases).
• Data Provenance: Retrospective, multisite clinical validation study. The data was collected in the United States. None of the studies in the test set were used for model development or analytical validation. The study population included 51.58% females and 48.42% males, with a mean age of 62.90 years. CT scanner manufacturers included Philips, Toshiba, Siemens, GE, and others.

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

• Number of Experts: Three.
• Qualifications of Experts: U.S. board-certified radiologists.

4. Adjudication Method for the Test Set

• Adjudication Method: Majority agreement between the three experts. (Described as "the reference standard (ground truth) was generated by the majority agreement between the three experts.")

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

• No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not reported. The study focused on the standalone performance of the AI algorithm.

6. Standalone Performance Study

• Yes, a standalone performance study was conducted. The results reported (sensitivity and specificity) are for the EFAI AASCTA by itself, "in the absence of any interaction with a clinician."

7. Type of Ground Truth Used

• Ground Truth Type: Expert consensus. Specifically, the "majority agreement between the three experts" (U.S. board-certified radiologists) determined the presence of AD or IMH for each case.

8. Sample Size for the Training Set

• The document does not explicitly state the sample size for the training set. It only mentions that none of the 380 studies in the validation test set were used for model development (training) or analytical validation.

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

• The document does not explicitly state how the ground truth for the training set was established. It only discusses the ground truth establishment for the test set.

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