(224 days)
The Opera Swing is indicated for performing general radiography, fluoroscopy and angiography procedures/applications. The device is intended for use in:
- Skeleton
- Chest and lungs
- Pediatrics
- Emergency/traumatology
- Gastroenterology
- Urology and gynecology
- Linear tomography
- Digital angiography
- Stitching
Not Found
The provided document K140380 is a 510(k) clearance letter for the GENERAL MEDICAL MERATE S.P.A. "Opera Swing" device, an image-intensified fluoroscopic x-ray system.
This document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications typically associated with AI/ML device evaluations. The letter is solely an FDA clearance stating substantial equivalence to a predicate device based on the indications for use.
Therefore, I cannot provide the requested information from this document. The sections you asked for, such as acceptance criteria, study details, sample sizes, and ground truth, are not present in this type of FDA clearance letter, which focuses on regulatory approval rather than technical performance data from a clinical study.
§ 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.