Rapid PE Triage and Notification (PETN)
iSchemaView Inc.Rapid PE Triage and Notification (PETN) is an AI-powered software that analyzes CT pulmonary angiography scans to detect and notify clinicians of suspected central pulmonary embolism cases. It assists hospital networks and clinicians by prioritizing patient workflows and flagging positive findings, helping improve timely diagnosis and treatment without altering original medical images.
Intended Use
Rapid PE Triage and Notification (PETN) is a radiological computer aided triage and notification software indicated for use in the analysis of CTPA images. The device is intended to assist hospital networks and trained clinicians in workflow triage by flagging and communication of suspected positive findings of central pulmonary embolism (PE) pathology in adults. The software is only intended to be used on single-energy exams.
Technology
Rapid PETN uses an artificial intelligence algorithm to analyze CTPA images and highlight cases with detected findings on a server or standalone desktop application in parallel to the standard of care image interpretation. It provides notifications with compressed preview images for informational purposes only. The device does not alter the original images and is validated for use on GE, Siemens, and Toshiba scanners.
Performance
Algorithm development and validation were performed using 600 CTPA cases from multiple sites, splitting into training and validation sets. The model achieved sensitivity of 0.98 and specificity of 0.97 in development and 0.96 sensitivity and 0.89 specificity in final validation with 306 CTPA cases. Software performance, verification, and validation testing demonstrated that the device met all design requirements. Testing included diverse patient ages, genders, scanner brands (GE, Siemens, Philips, Toshiba), and image acquisition parameters.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
2/22/2022
2 months - 2
FDA Approval
5/17/2022
Other devices from iSchemaView Inc.
- Rapid ASPECTS (v3)2024 • 510K
- Rapid (6.0)2024 • 510K
- Rapid SDH2023 • 510K
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