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Indications for use of TOMTEC-ARENA software are quantification and reporting of cardiovascular, fetal, and abdominal structures and function of patients with suspected disease to support the physician in the diagnosis.

TOMTEC-ARENA is a clinical software package for reviewing, quantifying and reporting digital medical data. The software can be integrated into third party platforms. Platforms enhance the workflow by providing the database, import, export and other services. All analyzed data and images will be transferred to the platform for archiving, reporting and statistical quantification purposes. TTA2 consists of the following optional modules: - IMAGE-COM - I REPORTING - AutoStrain LV / SAX / RV / LA I - 2D CPA - FETAL 2D CPA ■ - 4D LV-ANALYSIS - . 4D RV-FUNCTION - I 4D CARDIO-VIEW - I 4D MV-ASSESSMENT - I 4D SONO-SCAN - TOMTEC DATACENTER (incl. STUDY LIST, DATA MAINTENANCE, WEB ■ REVIEW) The purpose of this traditional 510(k) pre-market notification is to introduce semi-automated cardiac measurements based on an artificial intelligence and machine learning (AI/ML) algorithm. The Al/ML algorithm is a Convolutional Network (CNN) developed using a Supervised Learning approach. This Al/ML algorithm enables TOMTEC-ARENA to produce semi-automated and editable echocardiographic measurements on BMODE and DOPPLER datasets. The algorithm was developed using a controlled internal process that defines activities from the inspection of input data to the training and deployment of the algorithm: The training process begins with the model observing, and optimizing its parameters based on the training pool data. The model's prediction and performance are then evaluated against the test pool. The test pool data is set aside at the beginning of the project. During the training process, the Al/ML algorithm learned to predict measurements by being presented with a large number of echocardiographic data manually generated by qualified healthcare professionals. The echocardiographic studies were randomly assigned to be either used for training (approx. 2,800 studies) or testing (approx. 500 studies). A semi-automated measurement consists of a cascade of detection steps. It starts with a rough geometric estimate, which is subsequently refined more and more: The user selects a frame on which the semi-automated measurements shall be performed in TOMTEC-ARENA. Image- & metadata, e.g. pixel spacing, are transferred to the semi-automated measurement detector. The semi-automated measurement detector predicts the position of start and end caliper in the pixel coordinate system. These co-coordinates are transferred back to the CalcEngine, which converts the received data back into real world coordinates (e.g. mm) and creates the graphical overlay. This superimposed line can be edited by the user. The end user can edit, accept, or reject the measurement(s). This feature does not introduce any new measurements, but allows the end user to perform semi-automated measurements. The end user can also still perform manual measurements and it is not mandatory to use the semi-automated measurements. The semi-automated measurements are licensed separately.

Indications for use of TOMTEC-ARENA software are quantification and reporting of cardiovascular, fetal, and abdominal structures and function of patients with suspected disease to support the physicians in the diagnosis.

TOMTEC-ARENA (TTA2) is a clinical software package for reviewing, quantifying and reporting digital medical data. The software is compatible with different IMAGE-ARENA platforms and third party platforms. Platforms enhance the workflow by providing the database, import, export and other services. All analyzed data and images will be transferred to the platform for archiving, reporting and statistical quantification purposes. TTA2 consists of the following optional modules: - TOMTEC-ARENA SERVER & CLIENT . - . IMAGE-COM/ECHO-COM - REPORTING ● - AutoStrain (LV, LA, RV) ● - . 2D CARDIAC-PERFORMANCE ANALYSIS (Adult and Fetal) - . 4D LV-ANALYSIS - 4D RV-FUNCTION - . 4D CARDIO-VIEW - 4D MV-ASSESSMENT - 4D SONO-SCAN .