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The Consultiva™ Case Input Station is a software application that facilitates the digitization of medical images from a commercial digitizer and archives the digital images. The Consultiva™ Case Input Station is intended for use by a technician under the supervision of a medical professional.

The Consultiva™ Case Input Station (CIS) is a Windows-based program that facilitates the digitization of medical images and saves these digital images to a specified location on hard disk. Although the CIS is a stand-alone system, it requires a digitizer to get data. The CIS interfaces with the digitizer through high level programming interfaces that allow the CIS to initiate scans and receive messages from the digitizer. The CIS provides a User Interface (UI) that allows the user to initiate scans and verify the completion of the scans (visually) as well as view error information. The CIS can operate as a stand-alone system to collect medical images. It can also be the first step in a larger medical system. It interfaces with downstream products by sending and receiving messages. If configured in this mode, the CIS can display status information (e.g. Pass of Fail) to the user through the UI. The CIS also provides some Quality Control (OC) procedures to verify digitizer performance. These procedures are initiated from the CIS UI and require specific test films to be digitized and processed. In the regular workflow, the CIS also implements some quality checks on each image to ensure that the image is of sufficient quality.

The provided text is a 510(k) summary for the MiraMedica Consultiva™ Case Input Station, a software application designed to digitize and archive medical images. This document primarily focuses on the device's description, intended use, and substantial equivalence to predicate devices. It does not contain details about specific acceptance criteria, performance metrics, or study results.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details. The document explicitly states:

"Various tests of the software to verify system specifications are being performed. Verification procedures with pass/fail criteria were developed to ensure that the product met all the specified requirements."

This indicates that testing was planned and conducted, but the results and methodologies are not included in this summary.

In summary, none of the requested information about acceptance criteria and the study proving device performance is present in the provided document.

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