(88 days)
The URF Digital - OT is a device intended to visualize anatomical structures by converting a pattern of X-ray into a visible image through electronic amplification. The system has medical applications ranging from gastrointestinal examinations to cranial, skeletal, thoracic and lung exposures as well as examination of the urogenital tract. The units may also be used in lymphography, endoscopy, myelography, venography, pediatrics, arthrography, interventional radiology, digital angiography, and digital subtraction angiography (DSA).
URF Digital - OT is a universal fluoroscopic X-ray diagnostic system intended for use in Digital Fluoro Radiography (DFR) with an undertable image intensifier. The system is operated either via tableside control or via remote control console. The URF Digital - OT is available in two versions, the URF Digital - OT TOP and the URF Digital - OT Comfort.
I am sorry, but the provided text does not contain the information required to populate the acceptance criteria and study tables you requested. The document is a 510(k) summary for a medical device (URF Digital - OT), focusing on its substantial equivalence to a predicate device and its intended use. It does not describe specific acceptance criteria for device performance, nor does it detail a study that proves the device meets such criteria.
The document discusses the device's technical characteristics, its intended use, and its substantial equivalence to a previously cleared device (Siregraph T.O.P. 33 and 40). It mentions that "The URF Digital - OT has the same technological characteristics as the predicate Siregraph T.O.P 33 and 40." This suggests that the substantial equivalence argument relies on the predicate device's established performance rather than a new standalone study with specific performance metrics for the URF Digital - OT.
Therefore, I cannot provide the requested tables or details about the study, sample sizes, ground truth, or expert involvement based on the provided text.
§ 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.