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The Samsung RAYPAX™ Archive will be used to store & retrieve digital medical images and information about the images. The typical users are trained medical professionals.

The Samsung LTA can be part of RAYPAX PACS or can be a separate device for other manufacturer's PACS. It is used to store & retrieve digital medical images and information about the images using the DICOM 3.0 communication standard. RAYPAX LTA differs from some other PACS systems by having an additional storage unit management for medical images. The RAYPAX database stores and manages examination and patient information while the RAYPAX storage devices store and manage the medical images. To gather medical image data, RAYPAX uses DICOM 3. Using DICOM 3.0, medical-image producing equipment requests to store medical-image data in the DICOM gateway, which acts as the gateway to the Short Term Storage (STS). The DICOM gateway, after receiving such a request, stores the medical images in the STS. All the medical images that come into the STS are stored in the Long Term Archive. If there are images that need to be highly accessible, the LTA Manager transfers it to the STS. The RAYPAX system administrator sets this transferring authority.

The provided text describes a 510(k) Pre-Market Notification for the Samsung RAYPAX™ Long Term Archive (LTA) System, an archiving system for digital medical images. It focuses on regulatory submission and substantial equivalence to a predicate device, rather than performance studies of an AI-powered diagnostic device.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes for test and training sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, cannot be extracted from this document.

The document states:
"The 510(k) Pre-Market Notification for the LTA device contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device."
And also, "The LTA device does not contact the patient, nor does it control any life sustaining devices. A physician, providing ample opportunity for competent human intervention interprets images and information being printed."

This indicates that the focus of this 510(k) submission is on the safety and effectiveness of the archiving system itself, and its substantial equivalence to an existing predicate device (Olicon Imaging Systems Archive K973463), rather than on the diagnostic performance of an AI algorithm interpreting medical images.

No information is available in the provided text to populate the requested table and details.

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