(59 days)
The DRTS™ Remote Control Drape is intended to provide a sealed, sterile, see through cover for the hand held, DRTS remote control, or any similar sized instrument, when its use is required in the sterile field. Secondarily, the Remote Control Drape will protect the contained instrument from damage or contamination caused by unintended contact with body fluids, surgical solutions or other contaminants in the surgical field.
Not Found
The provided documents [0, 1] are a 510(k) clearance letter from the FDA for a device named "DRST™ Remote Control Drape" and its indications for use. These documents do not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment for an AI/ML device.
The DRST™ Remote Control Drape is a physical medical device (a sterile cover for a remote control), not an AI/ML software device. Therefore, the questions related to AI/ML device performance, training sets, test sets, ground truth, and expert evaluation are not applicable to this submission.
Thus, I cannot provide the requested information based on the given input documents.
§ 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.