APPRAISE-HRI is a mobile health app designed for military healthcare providers that uses vital signs like heart rate and blood pressure collected from an external monitor to assess and stratify the risk of hemorrhage in trauma patients. This helps medics identify individuals who need urgent care or evacuation by providing a continuous hemorrhage risk score in real-time, improving situational awareness and clinical decisions post-trauma.
Intended Use
The APPRAISE-HRI is a mobile health app intended to provide a means for military healthcare providers to screen U.S. Service members for hemorrhage risk after a physically traumatic event and stratify casualties who need immediate attention and emergency evacuation from those who are injured but may not be at risk for hemorrhage. It is not intended to diagnose or direct treatment, but to provide situational awareness and inform clinical management of potentially hemorrhagic casualties by identifying those at the greatest risk of hemorrhage.
Technology
APPRAISE-HRI is an Android application that collects heart rate, systolic, and diastolic blood pressure vital-sign data from a ZOLL Propaq M monitor via Bluetooth. It processes these data using an AI linear regression model algorithm to stratify hemorrhage risk into three levels. The app runs continuously and updates the risk score every minute, displaying vital signs and risk level to the user.
Performance
The device underwent rigorous software verification including unit, integration, and system testing following international standards (ISO 14971:2019 and IEC 62304). Usability testing with Army medics showed ease of use and accurate interpretation of results. Clinical utility validation was conducted on a large retrospective trauma patient dataset, demonstrating the algorithm effectively differentiated hemorrhage risk levels with strong likelihood ratios, indicating good discrimination between hemorrhage and control patients across subgroups.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/28/2023
6 months - 2
FDA Approval
4/5/2024
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