(83 days)
The Ziehm Vision RFD is intended for use in providing medical imaging for adult and pediations, using pulsed and continuous fluoroscopic digital imaging, as well as digital subtraction and cine image capture during diagnostic interventional and surgical procedures where intra-operative 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, neurology, neurosurgery, critical care, emergency room 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 any 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, quided toward the patient under control of the user at the direction who determines the specific clinical procedure. The images from the system assist the physicians in visualizing 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 devices such as external monitors, thermal video printers video display, wireless video server, injector connection and image storage devices (USB, DVD) and DICOM fixed wired and wireless network interfaces.
The modified Ziehm Vision RFD employs the same fundamental control, and substantially equivalent scientific technology as that of our predicate device Ziehm Vision RFD (K240099). Software architecture design is substantially equivalent to that of the predicate Ziehm Vision RFD.
This submission is for a software update to an existing device, the Ziehm Vision RFD, and also introduces new hardware options like an 8-inch IGZO panel. The provided text does not include detailed acceptance criteria or a study proving the device meets them in the context of device performance metrics (e.g., sensitivity, specificity, accuracy).
Instead, the documentation focuses on demonstrating substantial equivalence to the predicate device (K240099) through compliance with regulatory standards, design controls, and software testing. It emphasizes that no new questions regarding safety or effectiveness are raised by the modifications.
Therefore, I cannot provide a table of acceptance criteria and reported device performance from the provided text, nor can I answer specific questions about sample size for test sets, data provenance, ground truth establishment, expert involvement, or MRMC studies for measuring improvement with AI assistance. These types of studies are not typically required for software updates to established fluoroscopic X-ray systems unless there are significant changes to the imaging capabilities that would impact diagnostic performance.
Based on the provided text, here is what can be inferred/stated:
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A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated as performance metrics (e.g., sensitivity, specificity) in the provided text. The criteria are implied to be compliance with relevant safety, performance, and software standards, and that the modifications do not raise new questions of safety or effectiveness compared to the predicate.
- Reported Device Performance: Not reported in terms of diagnostic effectiveness. The document states that "system functionality is consistent with the user needs, intended uses, and performs as designed."
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Sample size used for the test set and the data provenance: Not mentioned.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned, as performance evaluation against ground truth (in a diagnostic sense) is not described.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not mentioned.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not mentioned. The device is an image-intensified fluoroscopic X-ray system, not an AI-powered diagnostic algorithm designed to assist human readers in image interpretation. While it includes "Image Insights" overlay and other features, the submission does not frame it as an AI-assissted diagnostic tool requiring MRMC studies for human reader improvement.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not mentioned. No standalone algorithm performance is discussed.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned.
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The sample size for the training set: Not mentioned.
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How the ground truth for the training set was established: Not mentioned.
§ 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.