(57 days)
The CLAROX is indicated for use only 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.
CLAROX is a battery-operated, portable dental X-ray source designed for handheld operation. It is designed to produce diagnostic quality X-ray images. The CLAROX 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 battery to allow for the use of the CLAROX where transportation or use of other x-ray devices might be prohibitive due to ther device's size and/or lack of mobility. The CLAROX is an X-ray device with a AC/DC adaptor. The handheld device features a main body (tube head), Cone for sensor, Acryl shielding, cradle, and AC/DC adaptor.
The provided document is a 510(k) summary for the CLAROX dental X-ray system, which is an X-ray generator. It focuses on demonstrating substantial equivalence to a predicate device based on technical specifications and adherence to recognized standards, rather than clinical performance (e.g., diagnostic accuracy). Therefore, many of the requested sections related to clinical studies, ground truth, expert review, and MRMC studies are not applicable or not detailed in this document.
Here's an analysis of the provided text in relation to your request:
Acceptance Criteria and Study to Prove Device Meets Criteria:
The document does not specify "acceptance criteria" in terms of diagnostic performance metrics (e.g., sensitivity, specificity, AUC) for the CLAROX device itself. Instead, it demonstrates substantial equivalence to a predicate device (KaVo NOMAD Pro2 Handheld X-ray System) by comparing technological characteristics and showing compliance with international safety and performance standards.
The study that "proves the device meets acceptance criteria" is described as non-clinical testing and bench testing to demonstrate compliance with these standards and similar technological characteristics to the predicate device.
1. Table of acceptance criteria and the reported device performance
Since the "acceptance criteria" are not explicit performance metrics for diagnostic capability, but rather conformance to standards and comparable technical specifications, the table below will reflect the comparison between the subject device (CLAROX) and the predicate device (KaVo NOMAD Pro2) as presented in the document. The "reported device performance" refers to the specifications of the CLAROX device.
| Characteristic | Acceptance Criteria (Predicate Device Specification) | Reported Device Performance (CLAROX) |
|---|---|---|
| Indications for Use | "The KaVo NOMAD Pro 2 Handheld X-ray System is indicated for use only 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 CLAROX is indicated for use only 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." |
| Body Size | 279mm(L) × 140mm(W) × 267mm(H) | 300mm(W) × 100mm(D) × 252mm(H) |
| Weight | 2.73kg | 1.5kg |
| Source to skin distance | 210mm | 200mm |
| Cone diameter | 60mm | 60mm |
| User Interface | Control buttons, display, and a trigger | control panel, control buttons, display, and an exposure button |
| Energy Source | Rechargeable 22.2 V DC Li-polymer battery core pack | Rechargeable 22.2 V DC Li-polymer battery core pack |
| Battery Capacity | 1.7 A-hr | 1.46 A-hr |
| Recharge capability | 70% remaining capacity after 300 cycles | 80% or above remaining capacity after 300 cycles |
| Exposure time | 0.02 - 1.0 seconds | 0.12 - 1.2 seconds |
| Timer Accuracy | ± (10% + 1ms) | Less than 5% or 20 ms |
| mA | 2.5 mA | 2.0 mA |
| kVp | 60 kVp | 70 kVp |
| Waveform | Constant Potential (DC) | Constant Potential (DC) |
| Compliance with Standards | - (Implicitly compliant with relevant standards) | AAMI ES60601-1; IEC 60601-1-2 (Ed. 4); IEC 60601-1-3; IEC 60601-2-65; ANSI AAMI IEC 62304:2006; EN ISO 14971:2019; ANSI AAMI IEC 62366-1:2015+AMD1:2020; IEC 60601-1-6 Ed. 3.1; IEC/EN 62133-2 Ed. 1.0 |
Note on Differences: While some specifications (e.g., weight, battery capacity, exposure time range, mA, kVp) differ, the document concludes that these differences do not raise new questions of safety or effectiveness and are within a range considered substantially equivalent for an extraoral X-ray source. For instance, the subject device has a lower weight and higher kVp compared to the predicate.
2. Sample size used for the test set and the data provenance
The document states, "Clinical testing is not necessary for the current submission, based on the device type (an x-ray generator) and based on the technological characteristics similar to the predicate system." Therefore, there is no test set of clinical images or patient data described in this submission. All testing was non-clinical (bench testing) to verify technical specifications and compliance with standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no clinical test set with a ground truth established by experts was used.
4. Adjudication method for the test set
Not applicable, as no clinical test set was used.
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
Not applicable. The CLAROX device is an X-ray generator, not an AI-powered diagnostic tool. Its submission is based on substantial equivalence as an X-ray source, not on improving human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable, as the CLAROX is an X-ray generator, not an algorithm, and does not perform diagnostic interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no clinical test set requiring ground truth for diagnostic accuracy was utilized. The "ground truth" in this context would implicitly be the validated specifications and performance of the predicate device and the requirements of the international standards.
8. The sample size for the training set
Not applicable. This device is an X-ray generator, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this device.
§ 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.