Loss of Pulse Detection is a software application from Fitbit designed to analyze pulse data collected by consumer wrist-worn devices to detect possible loss of pulse events. When such events are detected, it alerts the user with audio, visual, and haptic signals, and can prompt an emergency call if the user does not respond. This helps in early identification of critical cardiac events, improving patient safety by notifying potential emergencies.
Intended Use
Loss of Pulse Detection is a software-only mobile medical application intended to be used with compatible consumer wrist-worn products to analyze pulse data to identify loss of pulse events and provide audio, visual, and haptic alerts to the user. It is not intended to provide a diagnosis and is intended for over-the-counter use.
Technology
The software analyzes photoplethysmography (PPG) and accelerometer sensor data from compatible wrist-worn consumer devices. It uses digital signal processing and a convolutional neural network (CNN)-based machine learning algorithm to detect possible loss of pulse events. Alerts and emergency calls are triggered based on detection.
Performance
Performance testing included algorithm development on extensive PPG datasets, bench testing for signal quality with qualified devices, software testing, human factors validation with intended users, real-world evidence analysis, and clinical validation studies showing sensitivity around 69% and specificity above 99%. No device-related adverse events were reported.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/26/2024
5 months - 2
FDA Approval
2/25/2025
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