(72 days)
TREX Tilt-C, Integrated C-Arm/Table multipurpose radiographic/fluoroscopic positioning system. It is an all-digital multi-purpose system designed to address a broad variety of radiographic/fluoroscopic, interventional and limited angiographic procedures.
Integrated C-Arm/Table multipurpose radiographic/fluoroscopic positioning system, Model TREX Tilt-C. It is an all-digital multi-purpose system designed to address a broad variety of radiographic/fluoroscopic, interventional and limited angiographic procedures.
This 510(k) premarket notification is for a conventional medical device (TREX Tilt-C, Integrated C-Arm/Table multipurpose radiographic/fluoroscopic positioning system), not an AI/ML powered device. As such, the concept of "acceptance criteria" and "device performance" in the context of an AI model's metrics (like accuracy, sensitivity, specificity) is not directly applicable here.
The letter primarily focuses on the substantial equivalence determination for regulatory clearance based on the device's adherence to general controls and existing regulations. It does not contain information about studies proving performance against specific acceptance criteria in the manner requested for AI/ML devices.
Therefore, I cannot provide the requested information.
§ 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.