(221 days)
The OEC® 9900 Elite mobile fluoroscopy system is designed to provide fluoroscopic and spot-film images of the patient during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, urolagic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The system may be used for other imaging applications at the physician's discretion.
The OEC® 9900 Elite mobile fluoroscopy system is an image intensified fluoroscopic system consisting of two mobile units: a Mainframe (C-Arm) and a Workstation. The Mainframe (C-Arm) is comprised of a high voltage generator, x-ray control, and a "C" shaped apparatus, which supports an X-ray tube and an image intensifier. The Mainframe is designed to perform linear and rotational motions that allow the user to position the x-ray imaging components at various angles and distances with respect to the patient. The Workstation is a mobile platform that supports image display monitors, image processing and recording devices. Interfaces are provided for optional peripheral devices such as thermal or instant film printers.
The provided 510(k) summary for the OEC® 9900 Elite Mobile Fluoroscopic Imaging System does not include specific acceptance criteria or a detailed study proving the device meets those criteria in the format requested.
The document states:
- "Performance testing included in Section 18 Performance Testing – Bench and Section 19 Performance Testing - Animal of this 510(k) demonstrates that the OEC® 9900 Elite is safe, effective and performs in an equivalent manner to the predicate device(s) and in accordance with its labeling."
However, Sections 18 and 19 are not provided in the given text. Without these sections, the detailed information about acceptance criteria, reported performance, study methodologies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and specific comparative effectiveness or standalone study results cannot be extracted.
Therefore, I cannot populate the table or answer the specific questions based solely on the provided text. The submission only gives a high-level statement that such testing was performed and demonstrated equivalence to predicate devices.
§ 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.