(63 days)
XERO a is an Hand-held intraoral dental x-ray equipment to produce X-ray images using intraoral image receptors. It is indicated for use by a dental technician for both adult and pediatric patients. This equipment is used in a professional healthcare facility environment.
XERO a is an Hand-held intraoral dental x-ray equipment to produce X-ray images using intraoral image receptors. It is indicated for use by a dental technician for both adult and pediatric patients. This equipment is used in the professional healthcare facility environment. But the image detectors (an integral part of a complete dental system) are not part of the device. The operation principle of the device involves emitting x-ray source when a high voltage is supplied to the X-ray tube assembly, which frees electrons from the cathode. They hit anode to produce X-rays. The device acquires images by emitting X-rays continuously on the human tooth. And the functions of the dental generator XERO a are supported by firmware. This is of basic firmware documentation level, and there is no external data exchange port in the device. Moreover, the XERO a is not wireless. The subject dental system is not a cyber device.
The provided text describes the 510(k) premarket notification for the XERO - C and XERO α intraoral dental X-ray equipment. However, the document does not contain information about a study proving the device meets acceptance criteria related to AI/algorithm performance, multi-reader multi-case (MRMC) studies, or standalone algorithm performance.
The document primarily focuses on demonstrating substantial equivalence to a predicate device (Vatech Co., Ltd.'s EzRay Air Portable, K200182) through:
- Technological characteristics comparison: Showing similar design, mechanical features, electrical specifications, and adherence to relevant safety standards.
- Non-clinical data summary: Listing compliance with international and FDA-recognized consensus standards for medical electrical equipment safety, electromagnetic compatibility, usability, and specific requirements for dental X-ray equipment.
- Statement on clinical data: Explicitly stating that clinical studies are unnecessary to validate the safety and effectiveness of the device.
Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for an AI/algorithm. This information is not present in the provided 510(k) summary.
The device described is a medical imaging device (X-ray equipment), not an algorithm or AI software for image analysis that would typically have the kind of performance metrics and study designs you've asked about.
§ 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.