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EchoConfidence is Software as a Medical Device (SaMD) that displays images from a Transthoracic Echocardiogram, and assists the user in reviewing the images, making measurements and writing a report.

The intended medical indication is for patients requiring review or analysis of their echocardiographic images acquired for their cardiac anatomy, structure and function. This includes automatic view classification; segmentation of cardiac structures including the left and right ventricle, chamber walls, left and right atria and great vessels; measures of cardiac function; and Doppler assessments.

The intended patient population is both healthy individuals and patients in whom an underlying cardiac disease is known or suspected; the intended patient age range is for adults (>= 22 years old) and adolescent in the age range 18 – 21 years old.

EchoConfidence is Software as a Medical Device (SaMD) that displays images from a Transthoracic Echocardiogram, and assists the user in reviewing the images, making measurements and writing a report.

Here's an analysis of the provided FDA 510(k) clearance letter for EchoConfidence (USA), incorporating all the requested information:

Acceptance Criteria and Device Performance Study for EchoConfidence (USA)

The EchoConfidence (USA) device, a Software as a Medical Device (SaMD) for reviewing, measuring, and reporting on Transthoracic Echocardiogram images, underwent a clinical evaluation to demonstrate its performance against predefined acceptance criteria.

1. Acceptance Criteria and Reported Device Performance

The primary acceptance criteria for EchoConfidence were based on the "mean absolute error" (MAE) of the AI's measurements compared to three human experts. The reported performance details indicate that the device met these criteria.

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