BriefCase-Triage: CARE Multi-triage CT Body

BriefCase-Triage: CARE Multi-triage CT Body is a radiological software that analyzes contrast and non-contrast CT images of the chest, abdomen, and pelvis to assist hospital networks and trained medical specialists in workflow triage. The device flags suspected positive findings for 11 indications (including diverticulitis, appendicitis, bowel obstruction, solid organ injury, and pelvic fracture) and provides compressed preview images to prioritize urgent cases without altering original images or diagnostic workflow.

The subject device uses a foundation model-based artificial intelligence algorithm fine-tuned into a multi-triage module that detects 11 distinct clinical indications, compared to the predicate's single-triage module for aortic dissection. Both are deep learning algorithms integrated with image communication platforms (ICP) and PACS workstations, process DICOM CT images, and deliver compressed, unannotated, low-quality grayscale preview images for notification purposes. The subject device supports both contrast-enhanced and non-contrast CT, while the predicate requires contrast-enhanced exams.

Not stated in this summary.

The subject device is substantially equivalent to the predicate (BriefCase-Triage for AD, K251406) because both are radiological computer-aided triage and notification software using deep learning AI to process CT images and operate in parallel to standard care without altering original images or removing cases from the clinical queue. Both achieve time-sensitive case notification within several minutes, employ the same notification-only design with compressed preview images, serve the same user population (hospital networks and trained radiologists), and raise identical safety and effectiveness questions regarding accurate triage of findings. Performance testing demonstrates the subject device achieves AUC >0.95 and sensitivity/specificity >80% for all 11 indications, establishing parity with the predicate despite differences in clinical indications.