(75 days)
Routine Radiolgraphic/Fluoroscopic examinations of the entire human anatomy, gastrointestinal tract, full vascular/interventional capabilities, and organ examinations.
The Clinix mp is a remote controlled R/F X-ray system intended for radiographic/ fluoroscopic examinations of the entire human anatomy. This device may include signal analysis and display equipment, patient equipment supports, components and accessorial
The provided text describes a medical device, the Clinix mp, an R/F X-ray system. However, it does not contain information about acceptance criteria, device performance, a study to prove acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.
The document is primarily a 510(k) summary and an FDA clearance letter, which focus on demonstrating substantial equivalence to a predicate device and confirming regulatory compliance rather than presenting detailed performance study results.
Therefore, I cannot fulfill your request for the specific information you asked for based on the text provided. The text only states:
- "Effectiveness is established by MECALL's evaluation throughout all phases of the Clinix mp development. The product will perform in accordance with the development specifications."
This is a general statement about internal evaluation and adherence to specifications, not a detailed report of a study with specific acceptance criteria and performance metrics.
§ 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.