The Tyto Insights for Crackles Detection is an over-the-counter artificial intelligence (AI)enabled decision support software system used in the evaluation of lung sounds in adultsand pediatrics (2 years and older). It automatically analyzes the acoustic signal of the lungas recorded by the FDA 510k cleared compatible Tyto Stethoscope and identifies recordingswhere a specific abnormal lung sound suggestive of “Crackle” is suspected. It is not intendedto detect other abnormal or normal lung sounds. A licensed health care professional’s adviceis required to understand the meaning of the Tyto Insights for Crackles Detection result.Healthcare providers should consider the device result in conjunction with recording andother relevant patient data.
An external, hand-held, electronic listening device designed to be used by a healthcare professional for real-time detection and amplification of body sounds (e.g., heart, blood vessels, lungs) that may be difficult to perceive when using a mechanical stethoscope; it is not designed for electrocardiography (ECG). It is typically designed to be connected to a computing device, which may operate interpretive software sometimes provided with the stethoscope, for recording and/or displaying the results in the form of a graph [phonocardiogram (PCG)].