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PACS PLUS 5th EDITION is software 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.

Options make possible reading (including mammography), telecommunications; fast demonstration; etc .; and teleconferencing.

Lossy compressed mammographic images are not intended for diagnostic review. Mammographic images should only be viewed with a monitor approved by FDA for viewing mammographic images.

Typical users of this system are trained professionals, physicians, nurses, and technicians.

PACSPLUS 5TH Edition™ 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 517 Edition ™, 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.

The provided text is a 510(k) summary for the PACS PLUS 5th EDITION software. It describes the device's intended use and regulatory information but does not contain any information about acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study proving the device meets them based on the provided text. The document primarily focuses on demonstrating substantial equivalence to a predicate device and obtaining FDA clearance for marketing.

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