This study main objective is to evaluate the safety and efficacy of the UltraSight AI Guidance software. The investigational product is a software that guides the user to capture a high quality ultrasound image. The study will include healthcare professionals, not specialized in echocardiography, who will perform echocardiography by using UltraSight AI Guidance software, on subjects in the medical centers cardiac units.
This pivotal study is a multi-center, multi-reader multi-case (MRMC) study, designed to assess the quality of the clips obtained by novice users when using the UltraSight AI Guidance software. Prior to the study start, there will be a pre-study training phase for training the novice users. During the study, eligible subject will undergo the echocardiography examination twice on a single study visit (same day): once by one of the novice users when using the UltraSight AI Guidance software, and once by an expert sonographer without the aid of the software. Each novice user will perform the examination on at least 20 subjects (with the aim that the number of examinations by each novice will be similar). All examinations will be sent to multiple Board certified cardiologists for their quality evaluations.
Study Type
OBSERVATIONAL
Enrollment
240
Echocardiographic test.
University of Chicago Medicine
Chicago, Illinois, United States
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, United States
Sheba MC
Ramat Gan, Israel
Evaluation of the echo examination sufficiency.
The expert cardiologists will evaluate whether the echo examination quality obtained by novice users has sufficient to evaluate each of the primary endpoints: 1. Sufficient quality to assess Left Ventricular (LV) size: (YES/NO) 2. Sufficient quality to assess LV function: (Yes/No) 3. Sufficient quality to assess Right Ventricular size: (Yes/No) 4. Sufficient quality to assess presence of non-trivial pericardial effusion: (Yes/No)
Time frame: 1 year.
Evaluation of the echo examination quality.
The expert cardiologists will evaluate whether the echo examination performed by novice users has sufficient quality to evaluate the following six (6) anatomic elements: 1. Qualitative visual assessment of RV function: (Yes/No) 2. Qualitative visual assessment of left atrium size: (Yes/No) 3. Qualitative visual assessment of Aortic valve structure: (Yes/No) 4. Qualitative visual assessment of Mitral valve structure: (Yes/No) 5. Qualitative visual assessment of Tricuspid valve structure: (Yes/No) 6. Qualitative visual assessment of IVC size: (Yes/No)
Time frame: 1 year.
Evaluation of the echo examination diagnostic quality.
The expert cardiologists will evaluate if each of the following 10 views taken by novice users can be considered of diagnostic quality: * Apical 4 chamber * Apical 2 chamber * Apical 3 chamber * Apical 5 chamber * Para Sternal Long Axis * Para Sternal short axis - Aortic Valve (AV) * Para Sternal short axis - Mitral Valve (MV) * Para Sternal short axis - Papillary Muscle (PM) * Sub Costal - 4 chamber * Sub Costal - Inferior Vena Cava (IVC) In order to assess intra-cardiologist variability, a repeated assessment of the expert cardiologist analysis will be done in 10% of the exams.
Time frame: 1 year.
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