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The Siemens SOMATOM Definition Flash (with Stellar Detector) system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes* taken at different angles.

In addition the SOMATOM Definition Flash (with Stellar Detector) is able to produce additional image planes and analysis results by executing optional post processing features, which operate on DICOM images.

The images and results delivered by the system can be used by a trained physician as an aid in diagnosis.

(*spiral planes: the axial planes resulting from the continuous rotation of detectors and x-ray tube, and the simultaneous translation of the patient.)

The Siemens SOMATOM Definition Flash (with Stellar Detector) is a Computed Tomography X- ray System, which features two continuously rotating tube-detector systems and functions according to the fan beam principle. The system software is a command-based program used for patient management, data management, X-ray scan control, image reconstruction, and image archive/evaluation.

The SOMATOM Definition Flash (with Stellar Detector) produces CT images in DICOM format, which can be used by post-processing applications commercially distributed by Siemens and other vendors.

The computer system delivered with the CT scanner is able to run such post processing applications optionally.

The provided text is a 510(k) summary for the Siemens SOMATOM Definition Flash (with Stellar Detector) Computed Tomography X-ray system. This document focuses on demonstrating substantial equivalence to a predicate device (Siemens SOMATOM FLASH DS, K082220) rather than presenting a study with specific acceptance criteria and detailed performance data of the new device against those criteria in the context of clinical accuracy or diagnostic efficacy.

Therefore, the information requested in your prompt regarding acceptance criteria, device performance, sample sizes, expert qualifications, and detailed study methodologies for assessing the device's diagnostic capabilities is not contained within the provided text.

The document discusses the device's technical specifications, intended use, and general safety and effectiveness concerns related to its design and manufacturing practices, which are typically part of a 510(k) submission for demonstrating substantial equivalence for a medical imaging device. It does not include clinical performance studies with specific metrics like sensitivity, specificity, or reader agreement that would typically be associated with answering the questions you've posed.

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