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DiaCardio's LVivo Software Application is intended for non-invasive processing of already acquired echocardiographic images in order to detect, measure, and calculate the left ventricular function evaluation. This measurement can be used to assist the clinician in a cardiac evaluation.

The LVivo System analyzes echocardiographic patient examination DICOM movies for Global ejection fraction (EF) evaluation. EF is evaluated using two orthogonal planes, four-chamber (4CH) and two-chamber (2CH) views, to provide fully automated analyses of LV function from the echo examination movies. It also has the ability to measure strain

Here's a breakdown of the acceptance criteria and study information for the LVivo Software Application, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document focuses on the performance of the LVivoSG module and its correlation with established methods rather than explicit "acceptance criteria" presented as pass/fail thresholds. However, we can infer the desired performance from the study objectives and results.

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DiaCardio's LVivo EF Software Application is intended for non-invasive processing of already acquired echocardiographic images in order to detect, measure, and calculate the left ventricular wall for left ventricular function evaluation. This measurement can be used to assist the clinician in a cardiac evaluation.

The LVivoEF System analyzes echocardiographic patient examination DICOM movies for Global ejection fraction (EF) evaluation. EF is evaluated using two orthogonal planes, four-chamber (4CH) and two-chamber (2CH) views, to provide fully automated analyses of LV function from the echo examination movies.

Here's a breakdown of the acceptance criteria and study details for the LVivo EF Software Application (K130779), based on the provided text:

Acceptance Criteria and Device Performance

The provided text only explicitly states one primary endpoint and the corresponding result. The exact acceptance criteria (i.e., the numerical threshold for success) are not explicitly stated, but the device's performance is reported to have met this primary endpoint.

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