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The AXIOM Sireskop SD is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using either film cassettes or a digital mobile flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations.

AXIOM Sireskop SD is applicable for emergency treatment on an outpatient basis, as well as for bedside examinations.

AXIOM Sireskop SD is a floor-mounted universal fluoroscopic x-ray diagnostic system (R/F system), that was developed for tableside examinations in combination with an explorator. The explorator holds an image intensifier and the CCD camera.

AXIOM Sireskop SD can be configured as a single tube system, with only an undertable tube or a dual tube system which contains an additional 3D overhead tube crane, that can be moved longitudinally and laterally as well as vertically. The dual x-ray tubes allow a quick change between undertable and overtable exposure modes. The undertable tube is used for fluoroscopy and radiographic exposures taken with the Digital Imaging System. The overtable tube is suspended from an overhead tube support for exposures with a table bucky or bucky wall stand, either with film cassettes or a mobile Flat Detector. For processing the digital images from the Digital Imaging System or digital mobile Flat Detector, the AXIOM Sireskop SD is equipped with the Fluorospot COMPACT digital imaging system.

The provided text describes a 510(k) summary for the AXIOM Sireskop SD, an image-intensified fluoroscopic X-ray system. However, the document does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies for the AXIOM Sireskop SD.

The document states that the AXIOM Sireskop SD is substantially equivalent to previously cleared Siemens systems (AXIOM Sireskop SD (Sireskop SX) and AXIOM ICONOS R200 (URF Digital OT)). This suggests that the device's safety and effectiveness are based on its similarity to existing, legally marketed predicate devices, rather than on new, independent performance studies with detailed acceptance criteria.

Therefore, I cannot provide the requested information from the given text. The relevant sections with information about acceptance criteria, study details, and ground truth are entirely missing from this 510(k) summary.

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