Search Results

qER-CTA is a notification-only, parallel workflow tool for use by hospital networks and trained clinicians to identify and communicate images of specific patients to a specialist, independent of the standard of care workflow. qER-CTA uses a deep learning algorithm to analyze images for findings suggestive of a pre-specified clinical condition and to notify an appropriate medical specialist in parallel to standard of care image interpretation. Identification of suspected findings is not for diagnostic use beyond notification. Specifically, the device analyses CT angiogram images of the brain acquired in the acute setting and sends notifications to a neurovascular specialist that a suspected large vessel occlusion has been identified, recommending review of those images. Images can be previewed through a mobile application. qER-CTA is intended to analyze the internal carotid artery (ICA) and M1 segment of the middle cerebral artery (MCA) for LVOs on CTA scans of adults (≥ 22 years of age). Images previewed through the mobile application are compressed and for informational purposes only, not intended for diagnostic use beyond notification. Notified clinicians are responsible for viewing non-compressed images on a diagnostic viewer, conducting appropriate patient evaluation, and engaging in relevant discussions with the treating physician before making care-related decisions or requests. qER-CTA is limited to the analysis of imaging data and should not be used as a substitute for full patient evaluation or relied upon to make or confirm a diagnosis.

qER-CTA is a radiological computer-aided triage and notification (CADt) software designed to assist trained clinicians and radiologists in analyzing and triaging head CTA scans for suspected LVO (Large Vessel Occlusion) in the anterior circulation.

The software uses a deep learning algorithm to analyze CTA images and provide a case-level output available in the PACS or workstation for worklist prioritization or triage. It does not alter the original image, change the worklist order, or send proactive alerts directly to the end user. Instead, the end user can sort the worklist based on the passive notification flag. Images can be previewed through a mobile application also. There are two alternatives' users can choose from engaging with qER-CTA.

1. For de-identified CTA scans, they are sent to qER-CTA via transmission functions built within the user's PACS or workstation. Results are pushed back to the user's PACS or other user-specified radiology software database once the processing is complete.

2. For the client system that does not have de-identification and re-identification capabilities, qER-CTA interacts with on-premises gateway rather than directly with the PACS.

qER-CTA is not intended to direct attention to specific portions of the image, rule out target conditions, or be used as a standalone tool for clinical decision-making. It operates as a parallel workflow tool, independent of the standard of care, to assist in identifying and communicating suspected LVO cases to appropriate medical specialists for further review. Images previewed through the mobile application are compressed and are for informational purposes only.

1. Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

• Sample Size: 584 head CTA scans (289 LVO, 295 non-LVO).
• Data Provenance: Not explicitly stated in the provided text (e.g., country of origin, retrospective or prospective).

3. Number of Experts and Qualifications for Ground Truth Establishment (Test Set)

• Number of Experts: Three.
• Qualifications: U.S. board-certified neuroradiologists with at least 10 years of experience.

4. Adjudication Method for the Test Set

• The adjudication method is not explicitly mentioned. It states that "Three U.S. board certified neuroradiologists with at least 10 years of experience did the ground truthing," implying a consensus or majority vote might have been used, but specific details (e.g., 2+1, 3+1) are not provided.

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

• No, a MRMC comparative effectiveness study was not done. The document explicitly states that the performance was assessed using a "standalone study."

6. Standalone Performance (Algorithm Only) Study

• Yes, a standalone study was done. The performance of the qER-CTA device was assessed using a standalone study, evaluating its classification of large vessel occlusion.

7. Type of Ground Truth Used

• Expert Consensus: The ground truth was established by three U.S. board-certified neuroradiologists with at least 10 years of experience.

8. Sample Size for the Training Set

• The sample size for the training set is not provided in the given text.

9. How Ground Truth for the Training Set Was Established

• How the ground truth for the training set was established is not provided in the given text. The document only mentions the ground truthing for the clinical performance testing (test set).

Ask a specific question about this device