EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100)

EFAI APPENDICITIS is an AI-based radiological software that analyzes contrast-enhanced abdominal CT images to detect appendicitis and provide case-level notifications to clinicians for workflow triage. The device operates in parallel to standard care, flagging suspected positive findings without altering original images or removing cases from the reading queue.

Both the proposed device and predicate (BriefCase) use artificial intelligence algorithms to analyze abdominal CT images and generate case-level notifications for triage. The main difference is that the predicate provides notifications with compressed preview images, while the proposed device sends text-based JSON notifications. Both operate in parallel workflow, do not alter or annotate images, and do not segment or mark regions of interest.

IEC 62304:2006/A1:2015 (Medical device software lifecycle processes), ISO 14971:2019 (Risk management), 21 CFR Part 820.30 (Design controls), and FDA guidance documents on device software functions and cybersecurity.

Both devices are radiological computer-aided triage and notification software analyzing the same anatomical region (abdomen) via abdominal CT, target the same user population (trained clinicians), employ similar AI algorithms, and operate in parallel without modifying the standard workflow. Although EFAI detects appendicitis while the predicate detects intra-abdominal free gas, and notification format differs, these differences do not raise new safety or effectiveness concerns and do not impact the underlying AI-based triage technology.