(29 days)
The BlueWand™ LED Dental Curing Wand System is a cordless light intended for polymerization of visible light cured materials containing camphorquinone.
The BlueWand™ LED Dental Curing Light is a cordless battery-powered unit designed for curing visible light cured (VLC) materials whose initiators are sensitive to light in the 440-480 nm wavelength region of the visible spectrum. The light is based on LED (light emitting diodes) technology for light generation.
The BlueWand™ LED Dental Curing Light System includes:
- Surgical stainless steel handpiece with an LED and control electronics with . rechargeable battery
- Transformer to supply wall power to the base unit ●
- Base unit- charges battery and stores handpiece when not in use .
The BlueWand™ has 6 standard curing modes, consisting of 10, 20 and 30 second durations, and operational from two settings: Manual Setting and Automatic Setting. ("Touch less - ON" function). The Modes are10s, 20s, and 30s, a ramp, and two "30% reduced power" modes for 20s and 30s.
This regulatory document pertains to a 510(k) premarket notification for the "BlueWand™ Dental Curing Wand System." A 510(k) submission generally focuses on demonstrating substantial equivalence to a predicate device, rather than conducting a full clinical study with specific acceptance criteria, large sample sizes, or multi-reader multi-case studies typically associated with AI/algorithm performance.
Therefore, many of the requested categories (2-9) are not applicable or cannot be extracted from the provided text, as this type of submission does not require such detailed studies for performance and ground truth establishment in the same way as an AI diagnostic device.
Here's the information that can be extracted and a clear indication where information is not available due to the nature of the submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Intended Use | Curing camphorquinone-based visible light cured (VLC) materials |
| Operation | Cordless, battery-powered, LED-based light generation, 6 standard curing modes (10s, 20s, 30s, ramp, two "30% reduced power" modes for 20s and 30s) |
| Range of Light Emitted | 440-480 nm wavelength region of the visible spectrum |
| Curing Time | 10s, 20s, and 30s durations (and reduced power modes) |
| Cooling | Not explicitly detailed in performance, but stated as being equivalent to predicate. |
| Substantial Equivalence to Predicate Device (L.E. Demetron 1, K021797) | Claimed and accepted by FDA for intended use, operation, range of light emitted, curing time, and cooling. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Information Not Available: The document describes a medical device (a dental curing light), not a diagnostic algorithm. Performance is demonstrated through technical specifications and comparison to a predicate device, not typically through a "test set" of patient data in the way an AI diagnostic would be evaluated.
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)
- Information Not Applicable: Ground truth establishment by experts for a test set is not relevant for this type of device submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Information Not Applicable: Adjudication is not relevant for this type of device submission.
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
- Information Not Applicable: This device is a curing light, not an AI diagnostic system. Therefore, MRMC studies and "improvement with AI" are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Information Not Applicable: This is not an algorithm. Performance is assessed based on its physical properties and function.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Information Not Applicable: For a dental curing light, "ground truth" would relate to the physical properties of the light (e.g., wavelength, intensity) and its ability to cure materials, which are verified through engineering tests and material science, not clinical "ground truth" in the diagnostic sense. The document implies these tests were performed to support the claims of substantial equivalence.
8. The sample size for the training set
- Information Not Applicable: This is not an AI/ML device, so there is no training set.
9. How the ground truth for the training set was established
- Information Not Applicable: This is not an AI/ML device, so there is no training set or associated ground truth establishment method.
§ 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.