(30 days)
The ZIEHM QUANTUM series Mobile C-Arm is intended for use in both Radiographic and Fluoroscopic applications. It is suitable for a wide variety of surgical intervention or guidance procedures requiring X-ray imaging - both inside and outside the operating room. These procedures include Cerebral, Thoracic, Vascular, Biliary, Abdominal, Orthopaedic, Peripheral, Embolization, Stent Placement, Urological Special Vascular-I flow Procedures, and other related fluoroscopic examinations requiring interventional procedures.
The ZIEHM QUANTUM Mobile C-arms are also suitable as a back up for fixed-based X-ray Vascular and Intervention Procedures.
Radiographic film examinations can be made with an accessory cassette device attached to the Image Intensifier.
ZIEHM QUANTUM (Mobile x-ray system)
The provided document is a 510(k) premarket notification approval letter from the FDA for a mobile x-ray system (ZIEHM QUANTUM). This type of document generally approves a device based on its substantial equivalence to a predicate device and does not typically contain detailed information about specific acceptance criteria or comprehensive study designs with the level of detail requested in the prompt (e.g., sample sizes for training/test sets, expert qualifications, adjudication methods for ground truth, MRMC studies, standalone performance).
Therefore, based only on the provided text, it's not possible to describe the acceptance criteria and the study that proves the device meets those criteria with the requested level of detail. The document confirms the device's substantial equivalence to a predicate device for its stated indications for use, but it doesn't elaborate on the specific acceptance criteria or the specifics of studies conducted to demonstrate that equivalence.
The document only states the "Indications for Use" for the ZIEHM QUANTUM, which is a description of how the device is intended to be used, not a set of performance acceptance criteria. It also mentions "Radiographic film examinations can be made with an accessory cassette device attached to the Image Intensifier," which is a functional description, not a performance metric.
Without more detailed study reports, an answer to your prompt cannot be fully generated from this document.
§ 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.