(24 days)
The Ziehm Vision RFD is intended for use in providing medical imaging for adult and pediatric populations, using pulsed and continuous fluoroscopic digital imaging, as well as digital subtraction and cine image capture during diagnostic interventional and surgical procedures where intraoperative imaging and visualization of complex anatomical structures of both lower and higher contrast density are required. Such procedures may include but are not limited to those of interventional cardiology, heart surgery, hybrid procedures, interventional radiology, interventional angiography, electrophysiology, pediatrics, endoscopic, urological, gastroenterology, orthopedic, maxillofacial surgery, neurosurgery, critical care, emergency room procedures, and those procedures visualizing structures of the cervical, thoracic, and lumber regions of the spine, and joint fractures of the upper and lower extremities, and where digital image data is required for computer aided surgery procedures and whenever the clinician benefits from the high degree of geometric imaging accuracy, and where such fluoroscopic, cine and DSA imaging is required. The visualization of such anatomical structures assists the clinician in the clinical outcome.
This device does not support direct radiographic film exposures and is not intended for use in performing mammography. The system is not intended for use in all MRI environments.
The Ziehm Vision RFD employs X-rays as its imaging technology for visualizing human anatomy. The X-ray tube in the generator produces X-rays, guided toward the patient under control of the user at the direction of a physician who determines the specific clinical procedure. The images from the system assist the physicing the patient's anatomy. This visualization helps to localize regions of pathology and for surgical procedures. The device provides both real-time image capture visualization and of in vivo surgical procedures and post-surgical outcomes.
The Ziehm Vision RFD mobile fluoroscopy system is a flat panel detector (FPD) and fluoroscopic X-ray imaging system consisting of two mobile units: a Mobile Stand (C-Arm) and a Monitor Cart/Workstation. The Mobile Stand is comprised of a mono-block high voltage generator, X-ray control, and a C-Profile which is "C" shaped and supports the X-ray generator, and the image receptor Flat Panel Detector (FPD).
The mobile stand supports the optional wireless footswitch for the surgeon by removing the cable on the floor. The Monitor Cart is a mobile platform that connects to the Mobile Stand by a cable, and which integrates the LCD flat panel display monitors, image processing, user controls and image recording devices. Interfaces provided for optional perioheral devices such as external monitors, thermal video printers, wireless video server, injector connection and image storage devices (USB, DVD) and DICOM fixed wired and wireless network interfaces.
The proposed modified Ziehm Vision RFD employs the same fundamental control, and substantially equivalent scientific technology as that of our predicate device Ziehm Vision RFD (K231692). Software architecture design is substantially equivalent to that of the predicate Ziehm Vision RFD.
The provided text is a 510(k) summary for a medical device (Ziehm Vision RFD). It describes the device, its intended use, and states that verification and validation testing was conducted. However, it does not contain the specific details required to answer your questions about acceptance criteria and a study proving the device meets those criteria.
Here's why and what information is missing:
- Acceptance Criteria and Reported Device Performance: The document states that "Verfication and Validation testing were successfully conducted..." and "No new non-clinical image comparison with sets of images with the modified device and the predicate have been performed, the device equivalent regarding image quality." This implies that there were performance criteria related to image quality and other aspects, but the actual criteria (e.g., specific metrics like SNR, spatial resolution, contrast-to-noise ratio) and the reported numerical performance against these criteria are not provided.
- Sample Size, Ground Truth, Adjudication, MRMC, Standalone Study, Training Set Details: The document is primarily focused on demonstrating substantial equivalence to a predicate device due to a software update (operating system upgrade). It does not describe a clinical study of the device's diagnostic performance in the way you've outlined. The "Software testing" and "Cybersecurity testing" mentioned are about the software functionality and security, not diagnostic efficacy or accuracy in interpreting medical images.
Therefore, based solely on the provided text, I cannot complete your request. The information about the specific performance study you're asking for is not present in this 510(k) summary.
In a typical scenario where a device is evaluated for diagnostic accuracy (e.g., an AI-powered diagnostic tool), the 510(k) summary or accompanying documentation would include the details you're looking for. For a device like the Ziehm Vision RFD, which is an imaging system (fluoroscopic X-ray system), performance evaluations typically focus on technical imaging parameters (e.g., image quality, dose, resolution) and overall system functionality and safety, rather than a diagnostic accuracy study with a "ground truth" and "experts" in the way an AI diagnostic algorithm would be evaluated.
If you had a document describing a clinical performance study (e.g., a "Clinical Data Summary" or "Performance Testing Report") for this device, it would likely contain the information you're seeking.
§ 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.