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The CardioNow Cardiology Wide Area Archive and Retrieval System is intended to collect, archive, and display diagnostic information and images. The intent is to provide long-term archival as well as retrieval of this information to/from Hospital Site Servers and to provide compressed versions of these images to Internet Web Clients.

The CardioNow Cardiology Wide Area Archive and Retrieval System consists of: a Hospital Site System, the Internet Data Center, Web Client, and the ClinSend Client. Each Hospital Site System collects, archives, and displays diagnostic information and images. The Hospital Site System maintains the imaging exams and related data for local review. It also formats the data for transfer to the Internet Data Center.

This document is a 510(k) summary for the CardioNow Cardiology Wide Area Archive and Retrieval System. It mainly discusses the device's intended use and its substantial equivalence to a predicate device, focusing on its function as a cardiology archive and review system.

Based on the provided text, there is no information about specific acceptance criteria or a study demonstrating the device meets those criteria, as this device is a PACS system and not an AI/ML device.

Therefore, I cannot populate the table or answer the specific questions related to acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone performance for this submission. The document focuses on establishing substantial equivalence to a predicate PACS for archiving and displaying medical images.

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