Tyto Insights for Wheeze Detection
Tyto Care Ltd.Tyto Insights for Wheeze Detection is an AI-powered software tool that analyzes lung sounds recorded by the FDA-cleared Tyto Stethoscope to automatically detect the presence of wheezing. This helps clinicians by providing decision support in respiratory assessments for adults and children aged 2 years and older. It offers clear positive or negative wheeze detection results through a web interface accessible to healthcare providers and patients, improving remote and point-of-care lung sound evaluation.
Intended Use
An over-the-counter AI-enabled decision support software system used in the evaluation of lung sounds in adults and pediatrics (2 years and older) that automatically analyzes acoustic lung signals recorded by the FDA-cleared Tyto Stethoscope to identify recordings suggestive of wheeze, requiring licensed healthcare professional interpretation.
Technology
Tyto Insights for Wheeze Detection is a web-based AI software system composed of an Application Server, an Algorithm Server that processes audio files with an AI-enabled algorithm for wheeze detection, and a Web Server that provides graphical results. The system analyzes lung sound recordings acquired by the FDA-cleared Tyto Stethoscope and hosted in the cloud via IP network communications.
Performance
Performance was evaluated using a retrospective validation dataset of 371 lung sound recordings from 359 patients recorded by the compatible Tyto Stethoscope, with ground truth established by three blinded pulmonologists. The device demonstrated non-inferiority to the predicate device TytoCare Lung Sounds Analyzer (K221614) with sensitivity 54%, specificity 98%, and a higher area under the ROC curve (AUC). Minor user interface changes did not impact safety or effectiveness.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
7/28/2023
4 months - 2
FDA Approval
12/13/2023
Other devices from Tyto Care Ltd.
- Tyto Insights for Crackles Detection2024 • 510K
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