(28 days)
The Ziehm Vision FD is intended for use in providing medical imaging for general populations. The device provides pulsed and continuous fluoroscopic imaging of patients during diagnostic, interventional and surgical procedures. It is intended for use in visualizing complex anatomical structures and procedures such as vascular, cardiac, angiographic, cholangiography, endoscopic, urologic, orthopedic, neurologic, critical care, emergency room procedures, and where higher accuracy in image geometry is required. 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 near MRI systems.
The Ziehm Vision FD mobile fluoroscopy system is comprised of a mobile stand with a C-Profile shaped support with both a mono-block high voltage generator assembly and Flat Panel image receptor. Tehse attach to either end of a C-Profile providing a fixed SID. The device performs 2D medical imaging using 4 axes of manual movement and one vertical axes of motorized movement. A user touch screen provides for concise user selectable anatomical programs and X-ray technique control. Integrated high-resolution flat panel display monitors directly mounted on the clinican with a precise angle for visualization of live fluoroscopy images of the patient´s anatomy. This visualization helps to localize regions of pathology for surgical procedures. The mobile stand supports both a cable bound and optional wireless floorswitch. The Wireless footswitch operation allows for optimum positioning for the surgeon by removing the cable on the floor. The optional interface panel of the Ziehm Vision FD provides connection of peripheral devices such as external video printers, and image storage devices (USB, DVD) and DICOM fixed wire and wireless network interfaces.
There is no information in the provided text regarding acceptance criteria for a device, nor is there a study described that proves the device meets specific acceptance criteria.
The document is an FDA 510(k) clearance letter for a medical device (Ziehm Vision FD) and its accompanying 510(k) summary. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against pre-defined acceptance criteria through a specific study with statistical endpoints.
The document states:
- "The key modification refers to an updated release of the software, which incorporates an operating system upgrade from Ubuntu 16.04 to Ubuntu 20.04."
- "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."
- "Software testing was performed as required by "Content of Premarket Submissions for Device Software Functions". The Cybersecurity of the device has been improved."
This indicates that the focus of the submission was on validating the software upgrade and ensuring that the device's overall safety and effectiveness are maintained and equivalent to the predicate, not on a new clinical study to meet specific performance metrics.
Therefore, I cannot provide the requested information, specifically:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts and their qualifications for ground truth establishment.
- Adjudication method for the test set.
- MRMC comparative effectiveness study results or effect size.
- Standalone performance results.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
§ 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.