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This device is intended for use by health care professionals trained in the field of echocardiography or medical ultrasound. It is to be used when there is a need to convert ultrasound analog video to a digital video format for subsequent review and archiving. This device is also intended for use in transferring ultrasound images over digital networks and/or digital communication lines.

EchoLINK provides a telecardiology system, a complete image management system, and a stress echo acquisition and measurement system. There are four major components that make up the EchoLINK device; an image acquisition unit, a review station, a CDR library system, and the networking components.

The EchoLINK image acquisition unit (IAU) uses MPEG2 technology to convert analog video coming from the ultrasound machine to digital video in real time. The IAU can store up to 130 minutes of digital video data on its internal hard disk or 20 minutes on a removal digital storage device. The data storage format is in standard WindowsNT or DICOM 3. The IAU employs user-defined protocols for view indexing. The IAU allows for the placement of time markers within a view to identify the start and end of systole (necessary for stress echo applications) and allows the user to measure left ventricular function. The IAU is network-ready for transferring patient data to a central CDR library system and/or to a physician's review station. The EchoLINK device has an electronic report generator that allows the sonographer and physician to enter exam information as part of a paperless reporting system.

The EchoLINK device, when equipped with an optional modem or ISDN interface, can be remotely accessed to provide a variety of telecardiology solutions. The device is controlled by MPACS proprietary software.

The provided text does not contain any information about acceptance criteria or a study proving the device meets those criteria.

The document is a 510(k) summary for a medical device called EchoLINK, focusing on its substantial equivalence to previously marketed devices. It describes the device's functionality, its intended use, and a comparison with predicate devices.

Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria and performance studies based on the given input.

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