IRNF App
Apple Inc.The Irregular Rhythm Notification Feature 2.0 (IRNF 2.0) is a software application used on Apple Watch and iPhone that analyzes pulse rate data using machine learning to detect irregular heart rhythms, such as atrial fibrillation (AFib). It notifies users of possible AFib episodes to help prompt medical consultation, supporting non-invasive heart rhythm monitoring through wearable technology.
Intended Use
The Irregular Rhythm Notification Feature is a software-only mobile medical application intended to be used with the Apple Watch to analyze pulse rate data for identifying episodes of irregular heart rhythms suggestive of atrial fibrillation and provide a notification to the user for over-the-counter use.
Technology
IRNF 2.0 uses pulse rate data from Apple Watch PPG sensors and applies a convolutional neural network based machine learning algorithm to identify irregular heart rhythms consistent with AFib. The app runs on the Apple Watch and iPhone, synchronizing through HealthKit, and notifies the user if AFib is detected.
Performance
IRNF 2.0 was validated through clinical studies involving 573 participants wearing Apple Watch and ECG patches. The app demonstrated a sensitivity of 88.6% and specificity of 99.3% at the person-level for detecting atrial fibrillation, showing non-inferiority to its predicate device.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/10/2021
2 months - 2
FDA Approval
10/22/2021
Other devices from Apple Inc.
- Atrial Fibrillation History Feature2022 • 510K
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