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510(k) Data Aggregation
(91 days)
EzRay Air Portable, VEX-P300 (K200182)
Ai Ray Dental X-Ray Device 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.
Ai Ray Dental X-Ray Device is a super capacitor-operated, portable dental X-ray source designed for handheld operation. It is designed to produce diagnostic quality X-rays images utilizing either film or digital imaging techniques. The Portable Dental X-ray Device is designed for use in a dental office. It can also be used in other similar environments (orthodontic office, general practitioner's office, hospital ward, etc.) where appropriate safeguards are implemented. The device uses a rechargeable supercapacitor to allow for the use of the Portable Dental X-ray Device where transportation or use of other x-ray devices might be prohibitive due to the other device's size and/or lack of mobility.
This document describes the Ai Ray Dental X-Ray Device, an extraoral diagnostic dental X-ray source. The information provided focuses on the device's substantial equivalence to a predicate device, the EzRay Air Portable (Model: VEX-P300).
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Ai Ray Dental X-Ray Device are based on its compliance with various international and FDA standards for medical electrical equipment, radiation protection, and software lifecycle processes. The reported device performance is demonstrated by its adherence to these standards and its substantial equivalence to the predicate device.
| Characteristic | Acceptance Criteria (Compliance with Standards/Predicate Equivalence) | Reported Device Performance (as stated in the document) |
|---|---|---|
| Safety and EMC | Compliance with ANSI AAMI ES60601-1, IEC 60601-1-2, and other relevant safety and electromagnetic compatibility standards. | The device demonstrates compliance with ANSI AAMI ES60601-1, IEC 60601-1-2. The documentation states "The performance test demonstrated that the difference doesn't raise safety and effectiveness issues." for differences in electrical characteristics like exposure time, tube current, and tube voltage. |
| Radiation Protection | Compliance with IEC 60601-1-3, IEC 60601-2-65, FDA Guidance for Radiation Safety, and 21 CFR 1020.30 regarding radiation protection in diagnostic X-ray equipment and for handheld use. | The device demonstrates compliance with IEC 60601-1-3, IEC 60601-2-65. The backscattering shield meets FDA requirements. "The performance test demonstrated that the difference doesn't raise safety and effectiveness issues." for tube current and tube voltage. |
| Imaging Performance | Compliance with IEC 61223-3-4 for imaging performance of dental X-ray. The device should produce diagnostic quality X-ray images. | The device is designed to "produce diagnostic quality X-rays images." The performance testing demonstrated compliance with the noted standards, including imaging performance. |
| Software Life Cycle Processes | Compliance with IEC 62304:2006/A1:2015 and FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. | The device demonstrates compliance with IEC 62304:2006/A1:2015 and relevant FDA Guidance. |
| Usability Engineering | Compliance with IEC 62366-1 Edition 1.0 2015-02 for application of usability engineering to medical devices. | The device demonstrates compliance with IEC 62366-1. |
| Cybersecurity | Compliance with FDA Guidance for Content of Premarket Submissions for Management of Cybersecurity in Medical Devices. | The device demonstrates compliance with relevant FDA Guidance. |
| Substantial Equivalence | The device should be substantially equivalent to the Vatech Co., Ltd, Inc. EzRay Air Portable (Model: VEX-P300) in terms of indications for use, target populations, treatment method, and technological characteristics. Differences should not raise new or different questions of safety or effectiveness. | The document concludes that "The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. The Ai Ray Dental X-Ray Device is substantially equivalent to the Vatech Co., Ltd, Inc. EzRay Air Portable (Model: VEX-P300) cleared under K200182 with respect to the indications for use, target populations, treatment method, and technological characteristics." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide details on a specific "test set" for performance evaluation in the context of clinical data. Instead, it refers to Non-Clinical Performance Testing to verify substantial equivalence, focusing on compliance with established standards.
- Sample Size for Test Set: Not applicable in the context of clinical data for this submission. Performance was validated through compliance with standards.
- Data Provenance: Not applicable for clinical data. The device itself is manufactured by Guilin Woodpecker Medical Instrument Co., Ltd. in China.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
As no clinical data or test set requiring expert ground truth for comparison was used for this 510(k) submission, this information is not applicable. The device's performance was evaluated against technical and safety standards.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set requiring adjudication of ground truth was described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. The document explicitly states: "No clinical data was required to demonstrate substantial equivalence." Therefore, no MRMC study comparing human readers with and without AI assistance was performed or reported.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
No, this device is a physical X-ray device, not an AI algorithm. Its performance is related to its ability to generate X-ray images, not to interpret them or to function as a standalone AI system.
7. The Type of Ground Truth Used
The "ground truth" for the device's acceptance is its compliance with technical and safety standards (e.g., IEC 60601 series, FDA regulations 21 CFR 1020.30, 21 CFR 1020.31) and its substantial equivalence to a legally marketed predicate device. This is primarily assessed through non-clinical performance testing to verify the device's technical specifications and safety parameters.
8. The Sample Size for the Training Set
Not applicable. As this device is a physical X-ray generator, it does not involve a "training set" in the context of machine learning or AI algorithms.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this device.
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