Aevice Wheeze Detection Module
Aevice Health Pte. , Ltd.The Aevice Wheeze Detection Module is a software tool that uses advanced algorithms to analyze lung sound recordings from compatible electronic stethoscopes. It helps healthcare professionals identify recordings where wheezing, an abnormal lung sound suggestive of respiratory issues, is suspected. The tool acts as a decision support system and aims to improve the evaluation of patients' lung health, particularly in both children and adults, by supporting clinicians in detecting possible respiratory problems.
Intended Use
The Aevice Wheeze Detection module is a decision support software system used in evaluation of lung sounds in adults and pediatrics (2 years and older). It analyzes the acoustic signal of the lung such as lung sound recorded by FDA cleared compatible electronic stethoscope, such as AeviceMD, and identifies recordings where a specific abnormal lung sound suggestive of “Wheeze” is suspected. It is not intended to detect other abnormal or normal lung sounds. A licensed health care professional’s advice is required to understand the meaning of the Aevice Wheeze Detection result. Healthcare providers should consider the device result in conjunction with recording and other relevant patient data.
Technology
Software-only, stand-alone module that processes acoustic lung sound recordings from compatible FDA-cleared electronic stethoscopes using a machine learning-based algorithm to classify recordings as 'wheeze suspected' or 'not suspected.' The device does not directly provide a user interface, but its outputs are retrieved by host systems, allowing clinical integration.
Performance
The Aevice Wheeze Detection Module underwent clinical validation with a multisite, multisource dataset of 2,336 lung-sound recordings from 131 pediatric and adult patients. The device achieved a sensitivity of 73.15% and specificity of 84.12%, meeting predefined acceptance criteria (≥70% sensitivity, ≥80% specificity). Additional bootstrap analysis confirmed similar results, and various age groups were included. Non-clinical performance testing, software verification/validation, and cybersecurity testing were also performed per FDA and international standards.
Predicate Devices
No predicate devices specified
Ready to Sharpen Your Edge?
Subscribe to join 11k+ peers who rely on RadAISlice. Get the essential weekly briefing that empowers you to navigate the future of radiology.
We respect your privacy. Unsubscribe at any time.