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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.

Device Description

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.

AI/ML Overview

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., < kVp +10 %)	Met essential performance requirements (e.g., < kVp +10 %)	N/A
Reproducibility of Air KERMA	Met essential performance requirements	Met essential performance requirements	N/A
Leakage radiation test	Rendered satisfactory X-ray performance results	Rendered satisfactory X-ray performance results	N/A
Low Contrast & Line Pair performance	Met requirements	Met requirements	N/A

2. Sample size used for the test set and the data provenance:

This document describes performance bench testing of the X-ray device itself, not a test set of patient data for an AI algorithm.
The performance testing focused on device specifications and physical measurements (e.g., focal spot to skin distance, accuracy of loading factors, reproducibility of Air KERMA, HVL, leakage radiation, low contrast & line pair performance).
Therefore, the concept of a "test set" in the context of data provenance (country of origin, retrospective/prospective) is not applicable. The "samples" would be the X-ray device units undergoing technical testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is not applicable. Ground truth, in the context of image interpretation by experts, is not relevant to the technical performance testing of an X-ray generating device. The testing involved physical measurements and compliance with technical standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not applicable. Adjudication methods are used to establish ground truth for human-interpretable data, which is not the focus of this device's performance testing.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This information is not applicable. The device is an X-ray system, not an AI software. No MRMC study was conducted or required for this type of 510(k) submission.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

This information is not applicable. The device is an X-ray system, not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

This information is not applicable in the context of image interpretation. The "ground truth" for this device's performance revolves around objective physical measurements and compliance with established international and federal standards (e.g., IEC 60601 series, 21 CFR 1020.30, 1020.31) for X-ray generating equipment.

8. The sample size for the training set:

This information is not applicable. There is no mention of an AI algorithm or a training set for machine learning in this submission.

9. How the ground truth for the training set was established:

This information is not applicable.

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