(26 days)
The EzRay Air W (Model: VEX-S300W) is an intra-oral dental X-ray system (extra-oral X-ray source system) intended for use by a trained and qualified dentist or dental technician for both adult and pediatric subjects for producing diagnostic dental radiographs for treatment of diseases of the teeth, jaw, and other oral structures using intra-oral image receptors.
The EzRay Air W (Model: VEX-S300W) is an intra-oral dental X-ray system intended for intra-oral imaging, It consists of X-ray generator, X-ray controller, beam limiting device, operation panel and mechanical arm. The Xray controller allows for accurate exposure control, and the adjustable mechanical arm allows for easy positioning. The system can be used with an imaging system.
The provided text describes a 510(k) premarket notification for the EzRay Air W (Model: VEX-S300W) intra-oral dental X-ray system. This document is focused on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing extensive clinical trials or performance studies that would typically involve acceptance criteria for an AI-powered device.
Therefore, the information requested, particularly regarding acceptance criteria for an AI device, sample sizes for test and training sets, expert ground truth establishment, MRMC studies, and standalone performance, is not applicable to this submission. This is a submission for an X-ray imaging device itself, not an AI or software device that processes images.
However, I can extract the available performance information related to the device's technical specifications and how its performance was compared to the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance (Focus on X-ray system performance, not AI software):
| Acceptance Criteria (related to X-ray performance) | Reported Device Performance (EzRay Air W) | Predicate Device (VEX-S100W) Performance | Reference Device (EzRay Air, VEX-P300) Similarities |
|---|---|---|---|
| Minimum Source to skin distance: >= 200 mm | 200 mm | 200 mm (default), 300 mm (option) | 200 mm |
| X-ray field Size (default) | 60 mm round | 60 mm round | 60 mm round |
| Focal spot | 0.4 mm | 0.4 mm | 0.4 mm |
| Minimum half-value layer | 1.5 mm Al | 1.5 mm Al | 1.5 mm Al |
| Electric Power Voltage | AC 100-240 V | AC 100-120 V / 200 -240 V | Rechargeable 22.2 V DC Li-ion polymer battery pack |
| Rated Current | 10 A (at AC 250 V) | 16 A (at AC 250 V) | N/A |
| Exposure time | 0.05 - 0.5 seconds in 0.01 increments | 0.04 - 2.0 seconds in 0.01 increments | 0.05 - 0.5 seconds in 0.01 increments |
| Tube current | 2.5 or 3.0 mA fixed | 4 - 7 mA | 2.5 mA fixed |
| Tube voltage | 65 kVp fixed | 50 - 70 kVp | 60 or 65 kVp fixed |
| Operation mode | Manual Mode, Auto Mode | Manual Mode | Manual Mode, Auto Mode |
| Compliance with Safety Standards | IEC 60601-1, IEC 60601-1-3, IEC 60601-2-65, IEC 60601-1-2, 21 CFR 1020.30, 1020.31 | IEC 60601-1, IEC 60601-1-3, IEC 60601-2-65, IEC 60601-1-2, 21 CFR 1020.30, 1020.31 | IEC 60601-1, IEC 60601-1-3, IEC 60601-2-65, IEC 60601-1-2, 21 CFR 1020.30, 1020.31 |
| Accuracy of loading factors | Met essential performance requirements (e.g., |
§ 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.