(29 days)
The Toesco Aqua Blue LED Light Curing Device is intended to provide visible light irradiation for the curing of dental VLC resin products.
The Toesco Aqua Blue Led Light Curing Device is a gun-handle shaped dental curing light that is intended to polymerize dental materials such as resins and sealants by transmitting light through a light guiding tip. The source of blue light is a light-emitting diode. The device has two optional curing modes: two full power modes and a 2-step curing mode. It incorporates three pre-set programs and seven user programs. The power source is a 7.4 V Lithium Ion Battery. Wavelength is 450 nm - 480 nm, with wavelength peaking at 470nm.
The provided text describes the Toesco Aqua Blue LED Light Curing Device, its intended use, and its comparison to a predicate device for 510(k) clearance. However, it does not contain information about specific acceptance criteria, a study proving device performance against those criteria, or details regarding ground truth establishment, sample sizes, or expert adjudication.
The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed clinical study results against acceptance criteria.
Here's a breakdown based on the missing information:
1. Table of Acceptance Criteria and Reported Device Performance
Not available in the provided text. The document states "non-clinical testing (bench testing) demonstrates that any differences in their technological characteristics do not raise any new questions of safety or effectiveness," and lists several standards (IEC 60601-1-1, IEC 60601-1-2, Battery and Charger Testing, Environmental Testing, Reliability Testing) that were performed. However, it does not provide specific acceptance criteria values or the measured performance results for the Toesco Aqua Blue LED Light Curing Device against these criteria.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable/Not available. The document explicitly states "Discussion of Clinical Tests Performed: Not Applicable." This indicates that no clinical studies with a test set were conducted or required for this 510(k) submission. The non-clinical tests would have used specific test samples, but the number and nature of these test samples are not detailed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable/Not available. As no clinical tests were performed, there was no test set requiring expert ground truth establishment.
4. Adjudication Method for the Test Set
Not applicable/Not available. As no clinical tests were performed, there was no test set requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The document explicitly states "Discussion of Clinical Tests Performed: Not Applicable."
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This device is a hardware product (a dental curing light), not an algorithm or AI software. Therefore, the concept of "standalone algorithm performance" is not relevant.
7. The Type of Ground Truth Used
Not applicable/Not available. As no clinical tests were performed, there was no ground truth to establish in the context of device performance in a clinical setting. The "ground truth" for the non-clinical tests would be the established engineering standards and specifications for electrical safety, battery performance, environmental robustness, and reliability.
8. The Sample Size for the Training Set
Not applicable. This device does not involve AI or machine learning, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. This device does not involve AI or machine learning, so there is no "training set" or ground truth for it.
In summary, the provided document is a 510(k) submission for a non-AI dental device. The core of this submission relies on demonstrating substantial equivalence through non-clinical (bench) testing against a predicate device, rather than through clinical studies with defined acceptance criteria, ground truth, or expert evaluations.
§ 872.6070 Ultraviolet activator for polymerization.
(a)
Identification. An ultraviolet activator for polymerization is a device that produces ultraviolet radiation intended to polymerize (set) resinous dental pit and fissure sealants or restorative materials by transmission of light through a rod.(b)
Classification. Class II.