(92 days)
This X-ray Unit is intended to be used in portable applications, by a qualified/trained dentist or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of dental structures.
The Xcam is a portable X-ray for taking diagnostic radiographic exposures of body parts and operates on 11.1V DC supplied by a battery. Xcam is composed of x-ray generator including x-ray tubes, equipment controller, power controller, user interface and x-ray collimator. Xcam can be used with an imaging sensor. The image receptor, necessary component for a fully functional x-ray system, is not part of the submitted device.
The provided text is a 510(k) summary for the Xcam dental X-ray system, which focuses on demonstrating substantial equivalence to a predicate device (REXTAR X) based on technical characteristics and compliance with electrical safety, EMC, and radiation protection standards.
It does NOT contain information about acceptance criteria or a study that proves the device meets those criteria, particularly not in the context of AI/ML performance metrics like sensitivity, specificity, or AUC, or human reader studies with AI assistance.
The document discusses:
- Device Description and Indications for Use: The Xcam is a portable X-ray unit for diagnostic radiography of dental structures in adults and pediatric subjects, used by qualified dentists or technicians.
- Substantial Equivalence: It compares the Xcam's technical specifications (dimensions, weight, tube voltage, tube current, exposure time, filtration, focal spot size, etc.) to the predicate device, concluding no significant differences that would adversely affect use.
- Non-Clinical Testing: It mentions compliance with electrical safety (ES60601-1), electromagnetic compatibility (IEC 60601-1-2), radiation protection (IEC 60601-1-3, 60601-2-65), and EPRC standards. It also notes software validation for "MODERATE level of concern software" and cybersecurity considerations.
Therefore, based solely on the provided text, I cannot describe acceptance criteria or a study proving the device meets them in the manner requested (e.g., performance metrics, sample sizes for test/training sets, expert adjudication, MRMC studies, ground truth establishment). The document confirms the device meets regulatory standards for a traditional X-ray system, not an AI/ML-driven diagnostic aid.
To answer your request, if this were an AI/ML device, the missing information would typically be found in a separate section detailing the clinical performance study.
§ 872.1800 Extraoral source x-ray system.
(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.