(66 days)
The Swissray Medical AG Direct Digital X-ray Radiography diagnostic system class II (stationary) ddRCombi Trauma is a further development of the AddOn Multi System. This system can be used in a standard X-ray room and suitable for emergency / Trauma X-ray rooms.
The ddRCombi Trauma is intend for applying general radiography on a patient in a supine, seated or standing position.
The major system components are:
fix height adjustable patient table, X-ray generator, X-ray tube, Collimator, stand, ceiling suspension, digital AddOn bucky (4 CCD cameras), Image processing software and monitors.
I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the requested format. The document appears to be a 510(k) screening checklist and an FDA clearance letter for a device called "ddRCombi TRAUMA," an X-ray system.
While it mentions "Performance data : bench data," "Animal data," and "Clinical data" in the checklist, and that clinical data was present, it does not provide any specific details about:
- Acceptance criteria: What specific performance metrics were targeted (e.g., sensitivity, specificity, resolution, contrast, MTF values).
- Reported device performance: The actual outcomes of any tests against those criteria.
- Study details: Sample sizes, data provenance, number of experts, adjudication methods, MRMC study results, standalone performance, or ground truth establishment for either test or training sets.
The document primarily focuses on regulatory compliance aspects and technical specifications of the device from a manufacturing and classification standpoint, rather than a clinical performance study report.
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. 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). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary 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.