(99 days)
ZEN-2090 Pro is a mobile digital C-arm designed to provide fluoroscopic and radiographic images of the patient during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, orthopedic, neurologic, stone localization, critical care and emergency room procedures i.e. surgical interventions needing X-ray imaging and/or guidance and interventions inside and outside the operating room.
ZEN-2090 Pro is consisted of the X-ray tube, X-ray tube assembly, x-ray controller, XTV camera and some accessories. The ZEN-2090 Pro 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.
The provided text describes the 510(k) summary for the GENORAY Fluoroscopic X-Ray System (Model: ZEN-2090 Pro). It includes information about the device, its indications for use, and a comparison to predicate devices, asserting that it is "as safe and effective as the predicate devices" based on "bench and clinical evaluation." However, it does not contain the detailed information necessary to answer your specific questions regarding acceptance criteria and a study proving those criteria are met.
This document is a regulatory filing, and while it states the device's safety and effectiveness, it doesn't present the detailed study methodology, results, or specific acceptance criteria in the format you've requested.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance, because this information is not present in the provided text.
Based on the provided text, the following information is available:
- Device Name: Fluoroscopic X-Ray System (Model: ZEN-2090 Pro)
- Intended Use/Indications: To provide fluoroscopic and radiographic images of the patient during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, orthopedic, neurologic, stone localization, critical care and emergency room procedures i.e. surgical interventions needing X-ray imaging and/or guidance and interventions inside and outside the operating room.
- Safety and Effectiveness Claim: "The result of bench and clinical evaluation indicates that the new device is as safe and effective as the predicate devices."
- Predicate Devices:
To answer your questions accurately, a different type of document, such as a detailed clinical study report or a more comprehensive performance testing report, would be required.
§ 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.