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The Cardiac Guidance software is intended to assist medical professionals in the acquisition of cardiac ultrasound images. Cardiac Guidance software is an accessory to compatible general purpose diagnostic ultrasound systems. The Cardiac 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 Cardiac Guidance software is a radiological computer-assisted acquisition guidance system that provides real-time guidance during echocardiography to assist the user capture anatomically correct images representing standard 2D echocardiographic diagnostic views and orientations. This Al-powered, software-only device emulates the expertise of skilled sonographers. Cardiac Guidance is comprised of several different features that, combined, provide expert guidance to the user. These include: - 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. - Prescriptive Guidance: The prescriptive guidance feature in Cardiac Guidance provides direction to the user to emulate how a sonographer would manipulate the transducer to acquire the optimal view. - Auto-Capture: The Cardiac 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. - 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 Interpretation 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 an ultrasound device, personal computer, or a compatible DICOM-compliant PACS system in order to provide automated estimation of left ventricular ejection fraction. This measurement can be used to assist the clinician in a cardiac evaluation. The Caption Interpretation Automated Ejection Fraction Software is indicated for use in adult patients.

The Caption Interpretation Automated Ejection Fraction Software ("AutoEF") applies machine learning algorithms to process two-dimensional transthoracic echocardiography images for calculating left ventricular ejection fraction. The current implementation of the device adds a predetermined change control plan (PCCP) to the device cleared under K210747, which allows future modifications to the device. The version of Caption Interpretation AutoEF cleared under K210747 performs left ventricular ejection fraction estimation using apical four chamber (A4C), apical two chamber (A2C) and the parasternal long-axis (PLAX) cardiac ultrasound images. The software uses an algorithm that was derived through use of deep learning and locked prior to validation. The product operates as an add-in to a DICOM PACS system, ultrasound device, or personal computer. Caption Interpretation receives imaging data either directly from an ultrasound system or from a module in a PACS system. The device includes the following main components: 1. Clip Annotation and Selection: The AutoEF software includes a function that processes video clips in a study to automatically classify clips that are PLAX. AP4, and AP2 views. This view selection is based on a convolutional network. It also includes a function, Image Quality Score (IQS), that allows selection of best available PLAX, AP4, and AP2 clips within the study or provide an indication to the user if there are no clips with sufficient quality to estimate ejection fraction, based on prespecified IQS thresholds. 2. Eiection Fraction Estimator and Confidence Metric: The automated eiection fraction estimation is performed using a machine learning model trained on apical and parasternal long-axis views. The model is trained with a dataset from a large number of patients. representative of the intended patient population and variety of contemporary cardiac ultrasound scanners. The EF calculation can be performed on a 3-view combination (PLAX, AP4 and AP2), 2-view combinations (AP4 and AP2, AP2 and PLAX, AP4 and PLAX), or single views (AP4, AP2). The confidence metric provides expected error in left-ventricle ejection fraction estimation and is based on IQS.

The Caption Interpretation 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 an ultrasound device, personal computer, or a compatible DICOM-compliant PACS system in order to provide automated estimation of left ventricular ejection fraction. This measurement can be used to assist the clinician in a cardiac evaluation. The Caption Interpretation Automated Ejection Fraction Software is indicated for use in adult patients.

The Caption Interpretation Automated Ejection Fraction Software ("AutoEF") applies machine learning algorithms to process echocardiography images in order to calculate left ventricular ejection fraction. The cleared Caption Interpretation AutoEF performs left ventricular ejection fraction measurements using apical four chamber or apical two chamber cardiac ultrasound views, or the parasternal long-axis cardiac ultrasound view in combination with an apical four chamber view. The software selects the image clips to be used, performs the AutoEF calculation, and forwards the results to the desired destination for clinician viewing. The output of the Ejection Fraction estimate stated as a percentage, along with an indication of confidence regarding that estimate.

The Caption Guidance software is intended to assist medical professionals in the acquisition of cardiac ultrasound images. The Caption Guidance software is an accessory to compatible general purpose diagnostic ultrasound systems. The 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 computer assisted acquisition guidance system that provides real-time user quidance during acquisition of echocardiography to assist the user 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 quidance to the user. These include: - 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. - 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. - 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. - 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 Interpretation 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 an ultrasound device, 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 Caption Interpretation Automated Ejection Fraction Software is indicated for use in adult patients.

The Caption Interpretation Automated Ejection Fraction Software applies machine learning algorithms to process echocardiography images in order to calculate left ventricular ejection fraction. Caption Interpretation AutoEF performs left ventricular ejection fraction measurements using the apical four chamber, apical two chamber or parasternal long-axis cardiac ultrasound views or a combination of those views. The software selects the image clips to be used, performs the AutoEF calculation, and forwards the results to the desired destination for clinician viewing. The output of the program is the Ejection Fraction estimate stated as a percentage, along with an indications of confidence regarding that estimate.

The Caption Guidance software is intended to assist medical professionals in the acquisition of cardiac ultrasound images. The Caption Guidance software is an accessory to compatible general purpose diagnostic ultrasound systems. The 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 computer assisted acquisition guidance system that provides real-time user guidance during acquisition of echocardiography to assist the user 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: - 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. - 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. - 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. - 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.