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The 'eMurmur Heart AI' software is a decision support system in the evaluation of recorded patient heart sounds. The automated analysis by eMurmur Heart Al identifies specific heart sounds that may be present, including S1, S2, physiological heart murmurs, pathological heart murmurs and the absence of a heart murmur. eMurmur Heart AI is indicated for use in a setting where auscultation would typically be performed by a healthcare provider. It is not intended as a sole means of diagnosis. The heart sound interpretations offered by eMurmur Heart AI are only significant when considered in conjunction with healthcare provider over-read and including all other relevant patient data.

To analyze heart sounds via the eMurmur Heart AI, a digital recording of a patient's heart sounds is required. Recordings are made using a supported digital stethoscope, connected to a front-end client like, e.g., the eMurmur app or the eMurmur web portal. The recorded auscultation data are transmitted from the front-end client to the eMurmur backend, which hosts the eMurmur Heart Al. After analysis by the eMurmur Heart Al, the results of the analysis are returned to the front-end client where they are displayed to the user. The user can utilize the eMurmur Heart AI results to support their decision-making process regarding the potential presence and type of a heart murmur. eMurmur is a non-medical device software platform which includes the eMurmur backend, eMurmur apps and eMurmur web portal. The platform is used to stream, record, display. replay, and store auscultation data, recorded by means of supported digital stethoscopes. The eMurmur software platform has functions subject to FDA premarket review, i.e., eMurmur Heart AI, as well as functions that are not subject to FDA premarket review. For this application. FDA assessed those functions only to the extent that they could adversely impact the safety and effectiveness of the functions subject to FDA premarket review.

The eMurmur ID software system is a decision support device for the healthcare provider (the user) in the evaluation of patient heart sounds. eMurmur ID is used to record, display, analyze, and store the acoustic signal of the heart, recorded by means of an electronic stethoscope. The automated analysis will identify specific heart sounds that may be present, including S1, S2, physiological heart murmurs, pathological heart murmurs and absence of a heart murmur. eMurmur ID is indicated for use in a setting where auscultation would typically be performed by a healthcare provider. It is not intended as a sole means of diagnosis. The heart sound interpretations offered by eMurmur ID are only significant when considered in conjunction with healthcare provider over-read and including all other relevant patient data.

eMurmur ID is a software system comprised of the following components: 1. The eMurmur ID Backend, running on a server environment, hosts the eMurmur ID Heart Sound Analysis Algorithm, an encrypted database for archiving patient and user information, and an application programming interface (API) for communication with the web portal and mobile application. 2. The eMurmur ID Mobile App, which runs on a mobile device. The app permits the following activities: a. Electronic recording of heart sound signals via a compatible electronic stethoscope, the Littmann 3200 b. Visual and acoustic playback of heart and lung sounds c. Capturing patient information d. Transferring data to and from the eMurmur ID backend through a secure connection e. Displaying heart sound analysis results 3. The eMurmur ID Web Portal, which provides the following functionalities: a. Capturing and editing patient information b. Displaying and editing patient encounters including heart sound analysis results c. Visual and acoustic playback of heart and lung sounds d. Downloading reports (PDF) and heart and lung sound recordings e. Transferring data to and from the eMurmur ID backend through a secure connection The acquisition of the acoustic data is carried out by the FDA-cleared off-the-shelf electronic stethoscope Littmann 3200 by 3M (MN, USA) (K083903). For heart sounds to be analyzed by the heart sound analysis algorithm, a 20 second digital recording of the patient's heart sounds and the patient's date of birth are required. Heart sounds are recorded using the compatible, FDA-cleared, off-the-shelf electronic stethoscope Littmann 3200. The heart sounds are transmitted via Bluetooth to a mobile device running the eMurmur ID mobile app. The app then stores and sends the recorded data to the eMurmur ID backend for analysis. The results of the heart sound analysis are returned to the app within a few seconds, where they are displayed to the user together with the heart sound recording. The user can utilize the heart sound analysis results and the acoustic and visual representation of the heart sound recordings as decision support data in their decision-making process regarding the presence and type of a heart murmur.