(90 days)
The AMI1200 is intended to be used only by licensed practitioners; to produce imaging techniques required, providing the patient with an adequate diagnosis of their presented condition.
Not Found
The provided document is a 510(k) premarket notification letter from the FDA regarding the AMII200 C-Arm, an image-intensified fluoroscopic x-ray system. This type of document confirms that the device is "substantially equivalent" to predicate devices already on the market, allowing it to be marketed.
However, this letter does not contain any information about acceptance criteria, study details, performance metrics, sample sizes, ground truth establishment, or expert involvement as requested in your prompt. These details are typically found in the original 510(k) submission, which is a much more extensive technical document that is not appended to this FDA clearance letter.
Therefore, I cannot fulfill your request using the information provided in this document. The letter simply states that the FDA reviewed the submission and determined substantial equivalence based on the information provided by the manufacturer.
§ 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.