(194 days)
The Ziehm Vision RFD 3D system is intended for use in providing both 2D and 3D medical imaging for all adult and pediatric populations, using pulsed and continuous fluoroscopic imaging.
The device provides 2D medical imaging for fluoroscopy, digital subtraction, and acquisition of cine loops 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, neurosurgery, critical care, emergency room procedures, and those procedures visualizing structures of the cervical, thoracic, and lumbar regions of the spine and joint fractures of the upper and lower extremities, and where digital image data is required for Computer-Assisted Surgery procedures.
The device is also intended to provide 3D medical imaging of patients during orthopedic, neurological, intra-operative surgical procedures and where the clinician benefits from 3D visualization of complex anatomical structures, such as but not limited to those of high contrast objects, bones, joints, maxillofacial, cervical, thoracic, and lumbar regions of the spine, pelvis, acetabulum and joint fractures of the upper and lower extremities, and where digital image and C-arm positioning data is required for Computer-Assisted Surgery procedures.
The visualization of such anatomical structures assists the clinical outcome. At the discretion of a physician, the device may be used for other imaging applications. 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 RFD 3D employs X-rays as its imaging technology for visualizing human anatomy in both 2D and 3D imaqing. The X-ray tube in the generator produces X-rays, quided 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 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 and post capture visualization and of in vivo surgical procedures and post-surgical outcomes.
The Ziehm Vision RFD 3D mobile fluoroscopy system is a flat panel detector (FD) Computed tomography x-ray system 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 (FD).
The device performs both 2D medical imaging and the specialized 4 axes of motorized movement necessary for the 3D imaging. This provides the user/operator the option to use manual or motorized linear and rotational movements of the C- Profile for positioning of the imaging components at various angles and distances with respect to the patient using a control interface, Vision Center, Remote Vision Center or remote Position Control Center.
The motorization of the 4 axes provides the user an alternative for visualizing anatomical structures using a variable iso-centric location. The system working with a variable iso-center allows freely selectable positions of patient anatomy. The variable isocenter and distance control ensures that anatomical structures are safely visualized from different angles without re-adjusting the Carm or moving the patient. The iso-center is not restricted to orbital movements and can hold this iso-center during angulations and vertical travel using the 4 motorized axes. This same motion control provides the bases for 3D views of the patient anatomy. These 3D views are generated by means of an iterative algorithm.
The system uses the images of a scan captured with relation to a predefined scan center to compute the three-dimensional representation of an object. The 3D views are always displayed on the reference screen of the monitor cart. It is possible to display multiplanar reconstructions, orthogonal or freely selectable sections, and different surface reconstructions.
The Distance Control surface detection integrated around the lower edge of the flat panel detects objects, such as patients. When the flat panel approaches an object, the device reduces speed, slowing the motorized movement. The movement stops immediately before entering a defined safety zone.
The mobile stand supports the optional wireless footswitch for optimum positioning 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, 2D image processing, Optional 3D image processing, user controls and image recording devices. Interfaces provided for optional peripheral devices such as external monitors, thermal video printers, wireless video display, wireless video server, injector connection and image storage devices (USB, DVD) and DICOM fixed wired and wireless network interfaces.
The provided document is a 510(k) summary for the Ziehm Vision RFD 3D. While it details the device's indications for use, technological characteristics, and comparison to predicate devices, it does not contain information regarding a specific clinical study with acceptance criteria and reported device performance related to diagnostic accuracy or clinical outcomes.
The "Summary of Non-Clinical Test Data" section primarily focuses on:
- Compliance with internal functional specifications, design controls, and engineering standards.
- Verification and validation testing.
- Non-clinical image comparisons with predicate devices (Ziehm Vision RFD K132904 and Ziehm Vision2 FD Vario 3D K073346).
- Software verification/validation testing aligning with FDA guidance.
- Compliance with federal performance standards for X-Ray Fluoroscopic equipment (21 CFR 1020.30-32) and relevant voluntary safety standards (IEC standards).
Therefore, I cannot provide the specific information requested in the format of the questions, as the document primarily addresses substantial equivalence based on technological characteristics and compliance with safety and performance standards for an imaging device, rather than a clinical study evaluating diagnostic performance against predefined acceptance criteria for a specific clinical task.
Specifically, the document does not include:
- A table of acceptance criteria and reported device performance from a clinical study.
- Sample size used for a test set or data provenance for a clinical study.
- Number of experts or their qualifications for establishing ground truth in a clinical study.
- Adjudication method for a clinical study.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study, or effect sizes for AI assistance.
- Results of a standalone algorithm performance without human-in-the-loop.
- The type of ground truth used for a clinical study.
- Sample size for a training set.
- How ground truth for a training set was established.
The document's purpose is to demonstrate substantial equivalence to predicate devices based on technical specifications and non-clinical testing, not to present the results of a clinical performance study with specific acceptance criteria for diagnostic accuracy.
§ 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.