Annalise Enterprise
Annalise-AIAnnalise Enterprise is an artificial intelligence software designed to analyze chest X-ray images to detect several critical findings such as pneumothorax, tension pneumothorax, pleural effusion, pneumoperitoneum, and vertebral compression fractures. It supports clinicians by prioritizing studies containing these suspected findings to streamline and accelerate patient care workflow, aiding in triage and worklist management.
Intended Use
Device designed to be used in the medical care environment to aid in triage and prioritization of chest X-ray studies with features suggestive of pleural effusion, pneumoperitoneum, pneumothorax, tension pneumothorax, and vertebral compression fracture.
Technology
Annalise Enterprise uses an AI algorithm based on a convolutional neural network trained on over 750,000 chest X-ray images with labels from radiologists. It integrates with PACS/RIS systems to process studies and notify for prioritization if findings are detected, operating in parallel with standard clinical workflow.
Performance
Performance was validated with retrospective testing on 3,252 chest X-ray cases from four US hospital networks, showing high accuracy (AUC > 0.97) for each finding, and effective triage turnaround time (~42 seconds). Ground truth was established by consensus of board-certified radiologists.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
3/19/2025
1 month - 2
FDA Approval
4/23/2025
Other devices from Annalise-AI
- Annalise Enterprise CTB Triage Trauma2023 • 510K
- Annalise Enterprise CTB Triage Trauma2023 • 510K
- Annalise Enterprise CTB Triage-OH2023 • 510K
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