(55 days)
Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.
This is a new generation of Ceiling Suspension Radiographic System. This system is characterized by its simple and functional design. Thanks to its vertical and horizontal displacements, the suspension can cover almost all the room positions in which it is installed allowing all radiographic procedures. The system is modular and supports different configurations, such as radiographic system without radiographic table or without Wall Stand. The X-ray image receptors used in this system are digital detectors. X-ray film and Computed Radiography (CR) image receptors can be used but they rarely are these days. The device software used is the CANON CXDI which is supplied unmodified by CANON (Clearance numbers above). It has a moderate level of concern. The Radiographic System ChallengeX AP is provided with Auto-positioning, Auto-centering and Auto-tracking functions and it is composed of: Ceiling Suspension (OTC), Radiographic Table, Wall Stand, High Voltage X-ray Generator and acquisition image software. Auto-tracking allows the X-ray Tube to follow the Receptor when it changes position or the other way around while the SID remains constant. The "Auto" features were present and validated in the predicate system.
The document provided is a 510(k) premarket notification for a medical device called "Radiographic System Challenge X." This notification aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving that the device meets specific acceptance criteria in a clinical study with an AI component.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for AI-based analysis is not present in the provided text.
The document discusses non-clinical testing for compliance with international standards and FDA guidance for traditional medical device aspects such as safety, electrical compatibility, radiation protection, and software validation. It explicitly states that clinical testing was not required to establish substantial equivalence because the digital x-ray receptor panels already had previous FDA clearance.
Key takeaway from the document regarding studies:
- No AI component or AI-specific acceptance criteria are documented.
- The device is a traditional X-ray system, not an AI-powered diagnostic tool.
- Clinical testing was not performed for this submission. The substantial equivalence was established through non-clinical bench testing and compliance with existing standards and previously cleared components (like the detectors and software).
§ 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.