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Syntegra™ is a software application for multi-modality image registration and diagnostic fusion. Images are registered and displayed in a "fused" (overlaid in the same spatial orientation) format to provide combined functional and anatomical data providing different angular perspectives for interpretation by trained professionals

Syntegra™ is a software application for multi-modality image registration and diagnostic fusion. This application exists within the predicate device, Gemini 16 (K032036). The Gemini 16 is an imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT). This PET/CT device includes the processing station and applications contained within, such as image fusion. Syntegra™ may be offered as a standalone software application that has the capability to be utilized on any PC image processing workstations meeting the minimum hardware requirements to support the application.

Registration is the process of aligning two or more images from the same patient so that physical positions within each image are coincident. The images may be from the same imaging modality or different imaging modalities.

Fusion display is the visual combination of two image data sets that allows the data sets to be displayed simultaneously in a blended mode in the same screen window. The level of be arejected by user adjustable opacity values assigned to each data set. A common application of fusion display is the combination of physiological data from SPECT images and anatomical information from CT images.

Images are registered and displayed in a fused format to provide combined functional and anatomical data. The images are presented using various three-dimensional rendering techniques such as multi-planar reformatting, surface rendering with cut-planes, and maximum intensity projections.

Syntegra also offers Region of Interest tools. These are tools, which allow a user to draw two-dimensional contours around areas of interest on the transaxial image planes. The contours may then be exported to Radiation Therapy Planning systems, which use the two dimensional contours to generate three-dimensional volumes, which may be used in therapy planning.

The application operates on WindowXP/Intel Pentium computer systems with the following minimum requirements:

• Graphics Card: 24/32 bit color, support for 1400x1162 screen resolution .
• RAM: 1 GB .
• Processor: Pentium IV and above .
• Clock Speed: 1GHz clock speed .

The provided text describes a 510(k) summary for the Syntegra™ device, which is a software application for multi-modality image registration and diagnostic fusion. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement for testing or training sets.

The document focuses on:

• The device's intended use and description.
• Comparison to a predicate device (Philips Medical Systems Gemini 16, K032036).
• A declaration of substantial equivalence to the predicate device.
• The FDA's letter of clearance.

Therefore, I cannot provide the requested information from the given text. The text explicitly states "Syntegra is substantially equivalent to the image fusion software application from the following predicate device, Gemini (K032036), based on similar intended use and technological comparison." This suggests that the substantial equivalence argument was made based on technological comparison to an existing device rather than a new performance study against specific acceptance criteria.

To answer your request, I would need a different document that details the performance study conducted for Syntegra™, including the acceptance criteria and study results.

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