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The Siemens syngo Body Perfusion-CT software package has been designed to evaluate perfusion of organs and tumors. The software can calculate blood flow, blood volume and permeability from sets of images reconstructed from dynamic CT data acquired after the injection of contrast media. The package also allows the separate calculation of the arterial and portal venous component of hepatic perfusion.It supports evaluation of regions of interest and the visual inspection of time density curves. A potential application is the characterization of tumors by analysing the differences of perfusion parameters to normal tissue. Determination of the change of perfusion parameters during the course of treatment may be helpful in therapy monitoring.

Syngo Body Perfusion-CT is a post-processing software package, which runs on an Intel-based PC platform designed to post-process images acquired with SOMATOM CT scanners.

This document describes the syngo Body Perfusion-CT software package. However, the provided text does not contain any information about acceptance criteria or a study proving that the device meets such criteria.

The document is a 510(k) premarket notification summary, which primarily focuses on demonstrating substantial equivalence to previously cleared devices. It states:

• General Safety and Effectiveness Concerns: "The device labeling contains instructions for use and any necessary cautions and warnings, to provide for safe and effective use of the device. Risk management is ensured via a hazard analysis, which is used to identify potential hazards. These potential hazards are controlled via software development, verification and validation testing. To minimize electrical, mechanical, and radiation hazards, Siemens adheres to recognized and established industry practice and standards."
• Substantial Equivalence: It claims substantial equivalence to two other commercially available software packages (syngo Perfusion-CT and CT Perfusion 2).

While it mentions "verification and validation testing," it does not provide details about specific performance metrics, acceptance criteria, study designs, sample sizes, ground truth establishment, or expert involvement.

Therefore, I cannot provide the requested information in the table or answer the specific questions about the study, as this data is not present in the provided text.

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