(64 days)
Intended for use by a qualified/trained medical professionals, who have full understanding of the safety information and emergency procedures as well of capabilities and function of the device provides radiographic, multiradiographic and fluoroscopic imaging and is used for guidance and visualization during diagnostic radiographic, surgery, and interventional procedures. The device is to be used in healthcare facilities both inside and outside of hospital, in a variety of procedures of the skull, spinal column, extremities, and at the discretion of the medical professional the device may be used for other imaging applications on all patients except neonates (birth to one month) within the limits of the device. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. The system is not intended for mammography applications
The Virtual C DRF system is a mobile imaging system that acquire, process and display both static radiographic images and dynamic radiographic images such as multi-rad and fluoroscopy. Dynamic image acquisition is performed without the limitation of a mechanical linkage between the x-ray source and the x-ray detector. The mechanical linkage typical in existing dynamic imaging systems is either a c-arm or u-arm that ensures the alignment of the imaging components during image acquisition. The Virtual C DRF System features a novel collimator with built-in x-ray source to detector alignment software (Machine-Vision Collimator (MVC), combine they provide the technology for a "virtual c-arm" system. The novel MVC utilized four independent shutter to automatically position the radiation beam, so the area of exposure always remains within the confines of the active area of the detector. In addition, the angle and inclination of x-ray source is displayed to the operator. A visual display provides real time video images of the patient and a shaded area within the video images represent the location and size of the radiation beam with respect to the patient. As compared to our predicate device, there are three main changes: The digital receptor panel become a DRTECH brand panel, the generator changes from Sedecal to Source-ray, and and the collimator is changed from Colimar to a PortaVision "Machine Vision" collimator. An initial report was submitted for that collimator.
The provided document is a 510(k) Premarket Notification for the "Virtual C DRF Digital Imaging System." It focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving that the device meets specific acceptance criteria through a clinical study with an AI algorithm.
Therefore, the document does not contain the information requested regarding acceptance criteria for an AI-powered device, a study proving it meets these criteria, or details about expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance.
The document primarily discusses non-clinical testing (bench testing, electrical safety, EMC, software validation, cybersecurity) and a comparison of the new device's technical specifications and intended use against a predicate device. It explicitly states: "No clinical data is necessary to evaluate safety or effectiveness for purposes of determining substantial equivalence of the proposed modification."
In summary, none of the requested information (acceptance criteria table, study details, sample sizes, expert qualifications, ground truth, MRMC study, standalone performance) for an AI-powered device is present in this medical device submission.
§ 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.