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The EchoLive™ medical image management device family is designed for use in all medical specialties including, but not limited to, radiology, cardiology, gynecology, ENT, neurology, pediatrics, podiatry, chiropractic, general surgery, oral surgery and dentistry. The device may be used in medical offices and health care facilities, to facilitate access to clinical images and information, both archived and dynamic, in distributed locations over intranets, LANs, Internet, direct or dial dial-up telephone lines. The system may transmit a wide range of data including, but not limited to, Sonographs (Ultrasound images), Computer Tomography (CT), Magnetic Resonance Imaging (MRI), Positron Emission Tomography (PET). In addition the device may communicate standard audio, video and digital transmissions and recordings, providing complete clinical imaging handling, providing direct capture, retrieval, storage, and direct transmission and printing of images, reports, and patient information.

The EchoLive™ medical image management device family is a PACS capable of digital real-time simulcast transmission of medical images. Each model varies in the particular features and capabilities it offers the medical professional.

The provided document is a 510(k) summary for a PACS device (EchoLive™). It does not contain information about acceptance criteria or a study proving the device meets specific performance metrics.

510(k) submissions typically focus on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting new clinical performance studies with specific acceptance criteria as would be common for novel, high-risk devices or AI/CAD systems requiring performance validation.

Therefore, I cannot provide the requested information from this document.

Here's why and what information is missing:

• Acceptance Criteria and Reported Device Performance: This document states the device is a "Medical Image Management Device" and a "PACS." Its function is to transmit, store, and manage medical images. For such a device, "performance" would relate to its ability to handle various image formats, transmission speeds, storage capabilities, and display quality – none of which are quantifiable with specific acceptance criteria or results in this summary.
• Sample Size for Test Set and Data Provenance: Not applicable as no performance study is described.
• Number of Experts and Qualifications: Not applicable.
• Adjudication Method: Not applicable.
• MRMC Comparative Effectiveness Study: Not applicable. This is a PACS, not an AI/CAD system designed to assist human readers in diagnosis.
• Standalone Performance Study: No standalone performance study is mentioned as this is a PACS, not an AI algorithm intended for diagnostic interpretation.
• Type of Ground Truth Used: Not applicable.
• Sample Size for Training Set: Not applicable.
• How Ground Truth for Training Set Was Established: Not applicable.

In summary, this 510(k) summary is for a Picture Archiving and Communication System (PACS), which is a device for managing and transmitting medical images. It relies on demonstrating substantial equivalence to existing PACS devices rather than presenting a clinical performance study with specific acceptance criteria as would be expected for a diagnostic AI device.

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