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syngo® Single Source Dual Energy is designed to operate with CT images taken at the same anatomical region of a patient using two different kV levels. The differences in the energy dependence of the attenuation coefficient of the different materials provide information about the chemical composition of body materials. The images are combined to visualize and analyze information about anatomical and pathological structures.

The functionality of the syngo® Single Source Dual Energy applications are as follows:

• Gout Evaluation .
• Monoenergetic .

Dual Energy CT can be used to obtain intensity measurements with two different spectra and thus provides additional information when compared to single energy.

This additional information is analyzed in the post processing application syngo Single Source Dual Energy and can be used to improve the visualization of various materials in the human body.

After loading the reconstructed images corresponding to the two subsequent scans with different X-ray spectra into syngo® Single Source Dual Energy, the images are first registered to compensate for motion effects. They are then displayed using linear blending with selectable mixing ratio and color scale ("General Viewing"). Multiplanar reformations (MPR) of the volume are shown in 3 image segments, which are initialized as sagittal, coronal and axial view.

After arriving at an initial diagnosis on the basis of the CT-images, the user can choose between application classes Monoenergetic or Gout Evaluation.

These application classes are designed for specific clinical tasks, so that algorithms, additional tool buttons, the use of colored overlay images and image representation (for example MPR or maximum intensity projection) are optimized correspondingly. For Gout Evaluation a fourth image segment is used for volume rendering techniques (VRT). If is possible to adjust Gout Evaluation by using a configuration dialog. Special tools are available to remove the table or perform manual punching.

The provided text describes a special 510(k) submission for the Siemens syngo® Single Source Dual Energy software. It details the device's functionality, its claimed substantial equivalence to predicate devices, and the nonclinical testing performed. However, it does not contain information about specific acceptance criteria, a study proving the device meets those criteria, or details regarding sample sizes, expert involvement, ground truth establishment, or comparative effectiveness studies (MRMC).

The document primarily focuses on:

• Device Description and Intended Use: Explaining what the software does (post-processing dual-energy CT images to improve visualization of materials, with application classes like Monoenergetic and Gout Evaluation).
• Substantial Equivalence Claim: Stating that the device is substantially equivalent to previously cleared Siemens devices (syngo® Dual Energy with extended functionality (K083524) and syngo® Volume Perfusion - CT Body (K073373)) due to similar technology, intended use, and the unmodified use of an algorithm from a predicate device.
• Nonclinical Testing: Mentioning that verification and validation were performed for newly developed components and the complete software package according to standards like DICOM, IEC 60601-1-4, IEC 60601-1-6, IEC 62304, and IEC/ISO 14971. It states that "test results with the release acceptance criteria" were compared, but does not specify what those criteria were or what the results showed.

Therefore, I cannot populate the requested tables and information as the necessary details are not present in the provided text. The document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence rather than presenting detailed performance study results with specific acceptance criteria and outcome metrics a device is held to.

To answer your request, I would need a different type of document, such as a full study report or a more detailed section of a regulatory submission that outlines the performance evaluation and acceptance criteria.

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