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PACSPLUS™ is a device that receives digital images and data from various sources (e.g. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations.

PACSPLUS™ makes possible the capturing, storage, distribution, and networking of medical images at distributed locations. In cases where DICOM images are not directly available to PACSPLUS™, the system can acquire medical images using a DICOM gateway, which generates DICOM-type files. For example, film digitizers obtain images from old film and convert them to meet DICOM standards and stored. Stored files are transmitted using a network and can be viewed or manipulated from an imaging workstation.

This document is a 510(k) summary for a Picture Archiving Communications System (PACS) called PACSPLUS™. The document describes the device's indications for use and states that it has been determined substantially equivalent to a predicate device. However, this document does not contain information regarding acceptance criteria, a study proving the device meets acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or details about the training data.

The document focuses on the regulatory aspects of the device, primarily establishing its substantial equivalence to an existing product (MAROSIS™ PACS). It lists the device's ability to capture, store, distribute, and network medical images, and its intended users (trained professionals like physicians, nurses, and technicians).

Therefore, I cannot provide the requested table and information as the provided text does not contain these details. The 510(k) process for this type of device typically focuses on technical characteristics and intended use compared to a predicate, rather than detailed clinical performance studies with specific statistical endpoints like those requested in your prompt.

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