(58 days)
The Handheld Dental X-ray System, model XVbeam2000, is indicated for use only by a trained and qualified dentist or dental technician as an extraoral X-ray source to produce diagnostic X-ray images using intraoral image receptors. Its use is intended for both adult and pediatric subjects.
The subject device Handheld Dental X-ray System, model XVbeam2000, is a battery-operated, portable extraoral X-ray source system that is designed to generate X-rays to produce diagnostic quality intraoral X-ray images utilizing intraoral image receptors. The device can be used with three receptor types: film, digital intraoral X-ray sensors, and phosphor plates. The subject device is designed for use in a dental office or similar environments (hospital ward etc.) where appropriate safeguards are implemented. The subject device XVbeam2000 is an X-ray device with a DC generator. The handheld device features a main body (X-ray tube head), rechargeable battery (handset), charger, and charger AC/DC power supply. A beam-limiting cone is incorporated within the device. Internal and external shielding provide sufficient radiation protection to allow the clinician to remain in the operatory with the patient. The power is supplied by a rechargeable Lithium-Ion battery core pack built into a handset. This facilitates portability of the device.
The provided text is a 510(k) summary for a medical device (XVbeam2000 Handheld Dental X-ray System). This type of document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device, not a study proving the device meets specific acceptance criteria through clinical trials or performance studies that would typically generate the requested information.
Therefore, the requested information about acceptance criteria for device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not explicitly available in the provided document. The document focuses on demonstrating substantial equivalence through non-clinical performance testing and compliance with recognized standards.
However, I can extract the information that is present and note where the requested information is not provided.
Acceptance Criteria and Device Performance (Based on Non-Clinical Testing and Compliance with Standards)
The document states that "The test results show that all of the performance specifications have met the acceptance criteria. Verification and validation testing of the device was found acceptable to support the claim of substantial equivalence."
While specific numerical acceptance criteria and reported device performance for individual metrics are not tabulated, the document generally indicates that the device met the requirements of several FDA-recognized consensus standards for medical electrical equipment and X-ray systems.
Here's a table summarizing the general approach taken, as specific performance criteria and reported values are not detailed in the provided text:
| Acceptance Criteria Category (Implied by Standards) | Reported Device Performance (Summary from text) |
|---|---|
| System Integration and Functional Performance | Met all performance specifications and acceptance criteria. |
| Electrical Safety (IEC 60601-1) | Compliant with IEC 60601-1:2005+CORR. 1:2006+CORR.2:2007+A1:2012. |
| Electromagnetic Compatibility (EMC) (IEC 60601-1-2, IEC/TR 60601-4-2) | Compliant with IEC 60601-1-2:2014 and IEC/TR 60601-4-2 Edition 1.0 2016-05. |
| Radiation Protection (IEC 60601-1-3, IEC 60601-2-65, 21 CFR 1020.30 & 1020.31) | Complied with relevant radiation protection standards for diagnostic X-ray equipment and dental intraoral X-ray equipment. Leakage radiation reported as |
§ 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.