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510(k) Data Aggregation
(18 days)
EzRay Air Portable (Model: VEX-P300)
EzRay Air Portable (Model: VEX-P300) is an extraoral diagnostic dental X-ray source to produce X-ray images using intraoral image receptors. It is indicated for use by a dental technician for both adult and pediatric patients.
EzRay Air Portable (Model: VEX-P300), a portable dental X-ray system, operates on 21.6V DC supplied by a rechargeable Li-ion polymer battery pack. The portable x-ray generating device which is mainly designed for dental examination (teeth and jaw). The portable X-ray system is composed of an x-ray generating part with an x-ray tube including a device controller, a user interface, a beam limiting part, a back scattering shield, and an optional remote exposure switch. EzRay Air Portable (Model: VEX-P300) is designed to diagnose tooth and jaw through X-ray exposure using intraoral image receptors.
The provided document describes a 510(k) premarket notification for a dental X-ray device, the EzRay Air Portable (Model: VEX-P300). This submission focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving performance against novel acceptance criteria through a full-fledged clinical study.
Therefore, much of the requested information regarding acceptance criteria and a study to prove device performance as a new device is not directly applicable or available in the provided text. The document primarily details bench testing to confirm that changes to an existing device do not raise new questions of safety or effectiveness.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (Specified Standard/Requirement) | Reported Device Performance (Subject Device - EzRay Air Portable (Model: VEX-P300)) |
|---|---|---|
| Focal Spot to Skin Distance | Minimum length of 20 cm (implicit from comparison to predicate) | Longer than 20 cm |
| Accuracy of Loading Factors (kVp) | ≤ ±10% (essential performance requirement) | Met essential performance requirements |
| Reproducibility of Air KERMA | Met essential performance requirements | Met essential performance requirements |
| HVL (Half-Value Layer) | Satisfactory X-ray performance results in accordance with Federal Standard (21CFR 1020.30 and 31) requirements | Demonstrated similar performance outcomes to predicate, complied with requirements |
| Limitation of the X-ray Field | Satisfactory X-ray performance results in accordance with Federal Standard (21CFR 1020.30 and 31) requirements | Demonstrated similar performance outcomes to predicate, complied with requirements |
| Leakage Radiation Test | Satisfactory X-ray performance results in accordance with Federal Standard (21CFR 1020.30 and 31) requirements | Demonstrated similar performance outcomes to predicate, complied with requirements |
| Low Contrast & Line Pair Performance | Met requirements (implicit from "essential performance parameters" and standards compliance) | Met requirements |
| Battery Safety (for new battery) | Conformity with IEC 62133 (Secondary cells and batteries containing alkaline or other non-acid electrolytes – Safety requirements for portable sealed secondary cells) | In conformity with IEC 62133 |
| General Safety and Performance Standards | Compliance with IEC 60601-1, IEC 60601-1-3, IEC 60601-2-65, IEC 60601-1-2, 21 CFR 1020.30, 1020.31 | Complies with listed standards; all test results complied with requirements |
2. Sample Size Used for the Test Set and Data Provenance
The document describes bench testing and does not refer to a "test set" in the context of patient data or images. The "test set" would be the physical device itself and its components tested in a lab setting. The provenance of this test data (i.e., whether the bench tests were conducted in a particular country) is not specified. The testing is not based on a retrospective or prospective study with human subjects.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. Ground truth for image interpretation or disease diagnosis is not relevant in this type of bench testing. The "ground truth" for the performance tests comes from the established physical standards (e.g., 21 CFR 1020.30, 21 CFR 1020.31, IEC 60601 series). The experts involved would be engineers and physicists performing the standard compliance tests, not medical professionals establishing diagnostic ground truth from images.
4. Adjudication Method (for the test set)
Not applicable. There is no "adjudication method" in the context of diagnostic interpretation mentioned. The compliance of the device with technical standards is determined by direct measurement and comparison to defined thresholds.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. An MRMC study is designed to assess the performance of human readers, often with and without AI assistance, on diagnostic tasks involving patient cases. This document focuses on the technical safety and performance of an X-ray source, not an AI-powered diagnostic tool, and therefore no MRMC study was conducted or is relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable. The EzRay Air Portable (Model: VEX-P300) is an X-ray generating device, not an algorithm or AI product. Its performance is measured by its ability to produce X-rays according to specified technical parameters, not by an algorithm's diagnostic accuracy.
7. The Type of Ground Truth Used
The ground truth used for the device's technical performance is based on established regulatory and international standards for medical X-ray equipment. This includes:
- Physical measurements (e.g., focal spot to skin distance, leakage radiation).
- Electrical and X-ray beam parameters (e.g., kVp accuracy, Air KERMA reproducibility, HVL, X-ray field limitation).
- Safety standards (e.g., battery safety per IEC 62133).
8. The Sample Size for the Training Set
Not applicable. This device does not involve a "training set" as it is hardware, not a machine learning model.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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