(30 days)
The Siremobil C06 is a mobile x-ray system intended for use in operating room, traumatology, endoscopy, intensive care station, pediatrics, ambulatory patient care and in veterinary medicine. The Siremobil 06 can operate in six different modes: Digital Radiography, Fluoroscopy, Pulsed Fluoroscopy, Cassette Exposures, Digital Subtraction, and Roadmapping, which are necessary in performing wide variety of clivical procedures, such as intraoperative bile duct display, fluoroscopic display of intra-medullary nail implant in various positions, low dose fluoroscopy in pediatrics, fluoroscopic techniques utilized in pain therapy and positioning of catheters and probes.
The Siremobil C 06 is a mobile x-ray system which consists of a mobile C-arm configured with a high frequency generator, X-ray tube assembly, image intensifier, TV camera, film cassotte attachment, laser target devices, electronics cabinet, a monitor trolley and digital image storage system which consists of the digital memory device, image monitor(s), and user interface. The system is equipped with a footswitch and a hand switch for radiation release in the five modes of operation: digital radiography, fluoroscopy, pulsed fluoroscopy, subtraction, and roadmapping.
The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for the Siemens Siremobil C 06 mobile x-ray system, outlining its substantial equivalence to predicate devices and its intended use. There is no mention of specific performance metrics or studies conducted to establish acceptance criteria for the device's technical performance.
Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, study details, sample sizes, expert involvement, adjudication methods, MRMC studies, or standalone algorithm performance from the given text.
The closest information provided is the "Summary of Technological Characteristics of the Devices Compared to the Predicate" which states: "The imaging chain reflects the current standard of 10242 image processing and display with flat screen monitors. It was originally cleared with a stationary X-ray system (Uroskop Access) and is in clinical operation since more than 2 years." However, this does not constitute acceptance criteria or a study proving its fulfillment.
§ 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.