(79 days)
A cabinet x-ray system used to provide digital x-ray images of surgical and core biopsy specimens from various anatomical regions in order to allow rapid verification that the correct tissue has been excised during the biopsy procedure.
Doing the verification in the same room as the procedure or nearby improves workflow, thus reducing the time the patient needs to be under examination.
The Trident Specimen Radiography System is a self-contained, direct digital imaging system for imaging small to medium sized surgical and biopsy specimens. The system includes an X-ray generator, X-ray tube (microfocus), a-Se digital detector, 12 x 14 cm active imaging area, exposure timer, specimen chamber, control panel and an acquisition workstation. The lower 1/3 of the workstation's display monitor is the graphical user interface for the system. The upper 2/3 of the monitor is the display for the specimen radiographs. The system includes automatic exposure control functionality, but manual exposure techniques can also be sclected. The magnification tray can be adjusted and will allow images to be produced at 1.5 and 2.0 X magnifications.
The system is self-contained. Shielding is incorporated within the cabinet chamber system design, eliminating the need for separate additional shielding. The unit is mounted on a cart to be easily transported.
The provided information describes the Trident Specimen Radiography System but does not specify acceptance criteria or the details of a study comparing device performance against those criteria.
Instead, the document focuses on:
- Device Description: What the Trident system is and how it works.
- Indications for Use: What the device is intended for.
- Comparison to Predicate Devices: Stating that it has similar intended use, configuration, operation, and parameters to existing devices.
- Summary of Testing: Mentioning successful testing to safety and EMC standards (ISO 61010-1 and EMC Directive 2004/108/EC) and internal design control verification and validation according to 21 CFR Part 820 and 21 CFR 1020.40.
- 510(k) Clearance: The FDA's determination of substantial equivalence to predicate devices.
Therefore, I cannot provide the requested information about acceptance criteria, reported performance, sample sizes, expert qualifications, or adjudication methods for a performance study, as these details are not present in the provided text.
The document implies that the device "meets" its requirements by successfully passing safety, EMC, and internal verification/validation tests, and by being deemed substantially equivalent to predicate devices by the FDA. However, these are general compliance statements rather than a detailed performance study with specific acceptance criteria that would typically be found in a clinical or performance assessment 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.