Tyto Insights for Crackles Detection
Tyto Care Ltd.Tyto Insights for Crackles Detection is an AI-powered software that analyzes lung sound recordings made by a compatible stethoscope to detect abnormal lung sounds called crackles. It supports clinicians by providing automated detection to help evaluate lung health in both adults and children aged two years and older. The device aids healthcare providers in clinical decision-making by highlighting recordings suggestive of crackles, which may indicate underlying lung conditions.
Intended Use
The Tyto Insights for Crackles Detection is an over-the-counter AI-enabled decision support software system used in evaluation of lung sounds in adults and pediatrics (2 years and older). It automatically analyzes lung acoustic signals recorded by the FDA-cleared compatible Tyto Stethoscope and identifies recordings where abnormal lung sound 'Crackle' is suspected.
Technology
This is a cloud-hosted AI software system comprising an Application Server, Algorithm Server, and Web Server. It processes lung sound recordings from the FDA-cleared Tyto Stethoscope via telehealth server API communications. The core AI algorithm is a convolutional recurrent neural network (CRNN) trained to detect crackles from audio input segments up to 12 seconds. The system provides a positive or negative crackle detection result to both patients and clinicians through a web interface.
Performance
Clinical evaluation on 446 sound recordings from 445 patients (age 2+) showed high performance with Area Under the Curve (AUC) of 0.97. Sensitivity was 0.72 and specificity 0.99 compared to ground truth established by expert pulmonologists. The device was demonstrated non-inferior to clinical readers in detecting crackles in lung sounds recorded using the Tyto Stethoscope.
Predicate Devices
No predicate devices specified
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