Tyto Insights for Rhonchi Detection
Tyto Care Ltd.Tyto Insights for Rhonchi Detection is an AI-enabled software system that helps healthcare professionals detect abnormal lung sounds known as rhonchi from lung sound recordings. The system processes audio recorded using a compatible FDA-cleared digital stethoscope and provides decision support to clinicians in evaluating lung health, aiding in diagnosis and treatment decisions.
Intended Use
A prescription-use AI-enabled decision support system to automatically analyze lung sound recordings from a compatible FDA-cleared stethoscope and identify recordings suggestive of rhonchi in adults and pediatrics aged 2 years and older, to assist healthcare professionals in lung sound evaluation.
Technology
Web-based AI software that processes lung sound audio files from the FDA-cleared Tyto Stethoscope, hosted on cloud servers. It includes an application server, algorithm server running the AI detection algorithm, and web server providing graphical display of results. Communication is via IP network with integration into telehealth platforms.
Performance
Clinical validation against blinded pulmonologist readings on 400 recordings (100 positive for rhonchi and 300 negative) showed an AUC of 0.96, sensitivity of 0.60, specificity of 0.99, positive predictive value of 0.74, and negative predictive value of 0.99. The device demonstrated non-inferiority to clinical readers and excellent repeatability.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/18/2024
4 months - 2
FDA Approval
4/7/2025
Other devices from Tyto Care Ltd.
- Tyto Insights for Crackles Detection2024 • 510K
- Tyto Insights for Wheeze Detection2023 • 510K
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