(101 days)
The ADX4000 Cordless Portable Dental X-ray System is indicated for use only by trained and qualified dentists or dental technician for both adult and pediatric subjects for taking diagnostic extraoral dental X-rays using intraoral digital sensors or film.
The DexcoWinA ADX4000 Cordless Portable Dental X-ray System is a battery-powered hand-held dental x-ray machine whose fixed output is 60 k Vo (Constant Potential). It can be used with either a digital sensor or conventional film. This is a prescription device that can be used on pediatric and adult patients.
This document is a 510(k) summary for the DexcoWinA ADX4000 Cordless Portable Dental X-ray System. It describes the device and claims substantial equivalence to a predicate device. This type of document typically focuses on comparing the new device's specifications to a previously cleared device, rather than providing a detailed clinical study demonstrating the new device's performance against specific acceptance criteria.
Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not available in the provided text. The submission relies on demonstrating that the new device is "substantially equivalent" to an existing, legally marketed device, meaning it has the same intended use and similar technological characteristics, and any differences do not raise new questions of safety or effectiveness.
Here's a breakdown of the available information:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in terms of clinical performance (e.g., sensitivity, specificity, accuracy). Instead, it relies on demonstrating that the new device's technical specifications and intended use are substantially equivalent to a predicate device (NOMAD™ Dental X-ray System). The table provided compares features and specifications of the new device (DexcoWinA ADX4000) against the predicate device (NOMAD™):
| Feature | Acceptance Criteria (Implicitly, the Predicate Device's performance/specifications) | Reported Device Performance (DexcoWinA ADX4000) |
|---|---|---|
| Intended Use | The NOMAD™ Dental X-ray System is indicated for use by a trained and qualified dentist or dental technician for both adult and pediatric subjects as an extraoral diagnostic dental x-ray source to produce X-ray images using intraoral image receptors. | The ADX4000 Cordless Portable Dental X-ray System is indicated for use only by trained and qualified dentists or dental technician for both adult and pediatric subjects for taking diagnostic extraoral dental X-rays using intraoral digital or film sensors. (Substantially Equivalent) |
| Size: Body | 13"L x 11.5"H x 5.5"W | 5.5"H x 6.5"W x 3.2"D |
| Weight | 8.5 lbs | 4.4 lbs |
| Source to skin distance | 20cm | 20cm (Matches) |
| Cone diameter | 6cm | 5cm |
| Exposure Time | 0.01-0.99 seconds in 0.01 increments | 0.01-1.35 seconds in 0.01 increments |
| Timer Accuracy | ± (10%+1ms) | ± (10% + 1ms) (Matches) |
| mA | 2.3mA fixed | 1mA fixed |
| kVp | 60kVp fixed | 60kVp fixed (Matches) |
| Waveform | Constant Potential (DC) | Constant Potential (DC) (Matches) |
| Duty Cycle | 1:60 | 1:60 (Matches) |
| Electrical Safety Standards | IEC60601-1 & others. | IEC60601-1 & others (Matches) |
| Electromagnetic Standards | IEC60601-1-2 | EN60601-1-2 & others (Functionally Equivalent) |
| X-RAY PERFORMANCE | 21 CFR 1020.30, 1020.31, IEC60601-1-3, IEC60601-2-7 | 21 CFR 1020.30, 1020.31, IEC60601-1-3 (Functionally Equivalent) |
The "acceptance criteria" here are implicitly that the new device's technical specifications and regulatory compliance meet or are substantially equivalent to those of the predicate device, or fall within acceptable industry standards for dental X-ray systems.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. This is a premarket notification (510(k)) which primarily focuses on demonstrating substantial equivalence through technical comparisons and adherence to standards, rather than extensive clinical testing with patient data.
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 provided. As noted above, a clinical study with a test set and expert-established ground truth is not detailed in this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided.
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 provided. The device is an X-ray system, not an AI-powered diagnostic tool, so an MRMC study comparing human readers with and without AI assistance would not be applicable here.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. The device is a physical X-ray system, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
This information is not provided as there is no mention of a clinical study with a defined ground truth. The "ground truth" for this submission is effectively the established performance and safety profile of the predicate device and adherence to relevant national and international standards for X-ray devices.
8. The sample size for the training set
This information is not provided. There is no mention of a "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
This information is not provided as it's not relevant to this type of device and submission.
§ 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.