(49 days)
"AnyRay" is Portable X-Ray System intended to be used by trained dentists and technicians as an extraoral x-ray source for producing diagnostic x-ray images using intraoral image receptors. Its use is intended for both adult and pediatric subjects.
"AnyRay" is a wireless Portable X-Ray System that operates on DC22.5V supplied by a rechargeable Lithum-Polymer battery pack. The X-ray tubehead, X-ray controls and power source are ssembled into a single hand-held enclosure. The Package includes DC adaptor and Chair (Option) This equipment generates and controls X-ray in order to diagnose of tooth and jaw. It is composed of xray generator, controller, beam limiting device and chair (Option). Operating principle is that x-ay generated by high voltage electricity into x-ray tube, which (Openatifs primelpes in this x-ray images on receptor.
Here's a breakdown of the acceptance criteria and the study information based on the provided text for the "AnyRay" Portable X-Ray System:
1. Table of Acceptance Criteria and Reported Device Performance:
The document provided does not specify explicit "acceptance criteria" in terms of performance metrics like accuracy, sensitivity, or specificity for the device itself in producing diagnostic images. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (NOMAD Dental X-Ray System, K051795) based on technical and safety specifications.
The table below summarizes the key features and performance parameters compared to the predicate device, which implicitly serve as the "acceptance criteria" for demonstrating equivalence in a 510(k) submission of this nature. The "Reported Device Performance" column directly reflects the information provided for the "AnyRay" device.
| Feature | Acceptance Criteria (Predicate Device K051795) | Reported Device Performance ("AnyRay") |
|---|---|---|
| Intended Use | As extraoral x-ray sources to be used with intraoral image receptors for diagnostic imaging by dentists or dental technicians. (Both adult and pediatric subjects) | As extraoral x-ray sources to be used with intraoral image receptors for diagnostic imaging by dentists or dental technicians. (Both adult and pediatric subjects) |
| Body Size (L x H x W) | 13"L x 11.5"H x 5.5"W | 8.6"L x 6.0"H x 5.8"W |
| Weight | 8.5 lbs | 5.3 lbs |
| Source to Skin Distance | 20cm | 20cm |
| Cone Diameter | 6cm | 6.5cm |
| User Interface | Up-down buttons for exposure time selection, with timer display | Up-down buttons for exposure time selection, with timer display |
| Backscatter Radiation Protect | 6.75" dia. Pb-filled acrylic plastic scatter shield | Circular scatter shield |
| Exposure Switch | On tubehead assembly/control panel | On tubehead assembly/control panel |
| Tubehead Mounting | Handheld | Handheld |
| Energy Source | Rechargeable 14.4V DC NiCd battery pack | Rechargeable 22.5V DC Lithum-Polymer battery pack. |
| Exposure Time | 0.01 – 0.99 seconds in 0.01 increments | 0.06 s ~ 2.0 s seconds in 0.01 increments |
| Time Accuracy | ± (10% + 1ms) | ± (10% + 1ms) |
| mA | 2.3mA Fixed | 2 mA (Fixed) |
| kVp | 60kVp Fixed | 60 kVp (Fixed) |
| Waveform | Constant Potential (DC) | Constant Potential (DC) |
| Duty Cycle | 1:60 | 1:60 |
| Electrical Safety Standards | IEC60601-1, UL60601-1, EN60601-1 | IEC60601-1, EN60601-1 |
| EMI Standards | IEC 60601-1-2 | IEC 60601-1-2 |
| Performance Standards | 21 CFR 1020.30, 1020.31, IEC60601-1-3, IEC60601-2-7 | IEC60601-1-3, IEC60601-2-7, IEC60601-2-28, IEC60601-2-32 |
| Biocompatibility | - (Not explicitly stated or applicable for predicate) | Not applicable (No direct, indirect contact with patient) |
Study Proving Device Meets Acceptance Criteria:
The provided document describes a 510(k) premarket notification, which is a submission to the FDA to demonstrate substantial equivalence to an existing legally marketed device (the predicate device). It is not a clinical study in the traditional sense designed to prove superior performance or a specific diagnostic accuracy.
The "study" here is essentially the comparative analysis of the technical specifications and safety standards between the "AnyRay" device and its predicate, the NOMAD Dental X-Ray System (K051795). The conclusion states: "E-Woo Technology Co.,Ltd. concludes that the Portable X-Ray System "AnyRay" 's safety and effectiveness are substantially equivalent to predicate devices..." This conclusion is drawn from the detailed technical comparison presented in the table.
Here's an analysis of the requested information based on the 510(k) submission content:
2. Sample Size Used for the Test Set and the Data Provenance:
- Test Set: There is no "test set" in the context of image data for diagnostic performance evaluation mentioned in this document. The evaluation is based on a comparison of device specifications and adherence to recognized standards.
- Data Provenance: The data provenance is the device specifications provided by the manufacturer, E-Woo Technology Co., Ltd. for the "AnyRay" and specifications of the predicate device (NOMAD).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
- This information is not applicable to this type of 510(k) submission. There was no diagnostic image-based "ground truth" to be established for a test set by external experts.
4. Adjudication Method for the Test Set:
- This information is not applicable. There was no test set requiring expert adjudication.
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:
- No, an MRMC comparative effectiveness study was not done. This document pertains to an X-ray device (hardware) and its substantial equivalence in terms of technical specifications and safety, not an AI or software algorithm that assists human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, a standalone algorithm performance study was not done. This document is for a physical X-ray device, not an algorithm.
7. The Type of Ground Truth Used:
- Not applicable in the context of diagnostic performance. The "ground truth" here is effectively the accepted technical specifications and safety compliance demonstrated by the predicate device and relevant industry standards (e.g., IEC, FDA regulations).
8. The Sample Size for the Training Set:
- Not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the Ground Truth for the Training Set was Established:
- Not applicable. There is no "training set" for which ground truth would be established.
§ 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.