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The Caption Guidance software is intended to assist medical professionals in the acquisition of cardiac ultrasound images. Caption Guidance software is an accessory to compatible general purpose diagnostic ultrasound systems. Caption Guidance software is indicated for use in two-dimensional transthoracic echocardiography (2D-TTE) for adult patients, specifically in the acquisition of the following standard views: Parasternal Long-Axis (PLAX), Parasternal Short-Axis at the Aortic Valve (PSAX-AV), Parasternal Short-Axis at the Mitral Valve (PSAX-MV), Parasternal Short-Axis at the Papillary Muscle (PSAX-PM), Apical 4-Chamber (AP4), Apical 5-Chamber (AP5), Apical 2-Chamber (AP2), Apical 3-Chamber (AP3), Subcostal 4-Chamber (SubC4), and Subcostal Inferior Vena Cava (SC-IVC).

The Caption Guidance software is a radiological acquisition and/or optimization guidance system that provides real-time guidance to the users during acquisition of echocardiography to assist them in obtaining anatomically correct images that represent standard 2D echocardiographic diagnostic views and orientations. Caption Guidance is a software-only device that uses artificial intelligence to emulate the expertise of sonographers. Caption Guidance is comprised of several different features that, combined, provide expert guidance to the user. These include: - 1. Quality Meter: The real-time feedback from the Quality Meter advises the user on the expected diagnostic quality of the resulting clip, such that the user can make decisions to further optimize the quality, for example by following the prescriptive guidance feature below. - 2. Prescriptive Guidance: The prescriptive guidance feature in Caption Guidance provides direction to the user to emulate how a sonographer would manipulate the transducer to acquire the optimal view. - 3. Auto-Capture: The Caption Guidance Auto-Capture feature triggers an automatic capture of a clip when the quality is predicted to be diagnostic, emulating the way in which a sonographer knows when an image is of sufficient quality to be diagnostic and records it. - 4. Save Best Clip: This feature continually assesses clip quality while the user is scanning and, in the event that the user is not able to obtain a clip sufficient for Auto-Capture, the software allows the user to retrospectively record the highest quality clip obtained so far, mimicking the choice a sonographer might make when recording an exam. The Caption Guidance software was trained using echocardiographic clips from studies performed by trained sonographers. The ideal probe pose for each cardiac view was used to determine the Prescriptive Guidance for maneuvering the probe to the ideal pose. The Caption Guidance software is labeled for use with the Terason uSmart 3200t Plus, an FDA 510(k) cleared (K150533) ultrasound system. Caption Guidance is installed on the third-party ultrasound system. The user has access to both the Terason user interface (UI) and the Caption Guidance UI and will be able to switch between the two.

The Bay Labs, Inc. EchoMD Automated Ejection Fraction software is used to process previously acquired transthoracic cardiac ultrasound images, to store images, and to manipulate and make measurements on images using a personal computer or a compatible DICOM-compliant PACS system in order to provide automated estimation of left ventricular ejection. This measurement can be used to assist the clinician in a cardiac evaluation. The EchoMD Automated Ejection Fraction Software is indicated for use in adult patients.

The EchoMD Automated Ejection (AutoEF) software applies machine learning algorithms to process echocardiography images in order to calculate left ventricular ejection fraction. The software operates in between the DICOM source and the DICOM destination. EchoMD AutoEF performs left ventricular ejection measurements using both the apical four chamber and apical two chamber cardiac ultrasound views. The software selects the image clips to be used, performs the AutoEF calculation, and forwards the results to a destination PACS server for clinician viewing. The output of the Ejection Fraction estimate stated as a percentage, which is displayed via the destination PACS system. The software applies machine learning algorithms to assess image quality and provides this information as qualitative and quantitative user feedback. By automating the estimation of ejection fraction, the EchoMD software is designed to streamline the clinician's calculation of the measurement.