(21 days)
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.
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.