(16 days)
The LED Turbo is a dental curing light that is designed for use in the polymerization of dental resins and the activation of bleaching materials.
The LED Turbo consists of a handy unit and a battery charger. The handy unit contains a programmed control circuit, high intensity dental blue LED light source, a light guide and a optical fiber that conduct light to the treatment area on the patient. The control circuit which governs the output power rate, timing and monitoring the temperature of the LED.
The provided text describes the 510(k) premarket notification for the "LED Turbo" dental curing light. This submission is for a medical device that cures dental resins and activates bleaching materials, not an AI/ML device, and therefore does not include the typical acceptance criteria and study designs associated with AI/ML device evaluations.
However, based on the information provided, I can construct a table comparing the device's performance against its predicate device, which serves as a form of "acceptance criteria" in the context of a 510(k) submission for substantial equivalence.
Here's an analysis based on the provided text, focusing on how a comparison-based "acceptance" is demonstrated:
1. Table of Acceptance Criteria and Reported Device Performance
For a 510(k) submission, the "acceptance criteria" for a new device are primarily its substantial equivalence to a legally marketed predicate device. This is demonstrated by comparing key technical specifications and functional performance. The table below presents the comparison found in the document.
| Feature | Predicate Device (Ultra-Lite 200E Plus) | Proposed Device (LED Turbo) | "Acceptance Criteria" (Substantial Equivalence) |
|---|---|---|---|
| 1. Light Intensity | Min. 800mW/cm² | 1100mW/cm² (Min. 800mW/cm²) | Meets or exceeds predicate |
| 2. Output Wavelength | 440nm~490nm | 440nm~490nm | Identical to predicate |
| 3. LED Power Consumption | 1 Watt | 5 Watt | Different, but within functional parameters* |
| 4. Battery Use | 9.6V/300mAh | 7.2V/1900mAh | Different, but within functional parameters* |
| 5. Operating Voltage | AC110V, AC120V, AC230, 50/60Hz | AC100V~260V 50/60Hz | Compatible with broader range than predicate |
| 6. Weight | 380 g | (Not explicitly stated for LED Turbo) | Not directly comparable from text |
| 7. Curing Time | 20 seconds | 5, 10, 20, 40 seconds selectable | Offers more options, includes predicate's time |
| Intended Use | Dental curing light for polymerization of dental resins and activation of bleaching materials | Dental curing light for polymerization of dental resins and activation of bleaching materials | Identical |
| Operational Principles | Identical | Identical | Identical |
*Interpretation: The differences in LED power consumption and battery use are presented as technical differences that still achieve equivalent or improved performance (e.g., higher intensity, shorter curing times) while maintaining safety through "Performance testing ... that confirms that the halogen light technology used for LED Turbo is able to cure resin and activate tooth bleaching agents within the specified timeframe without causing thermal damage to the tissue." This "performance testing" is the closest equivalent to a direct study proving criteria.
2. Sample Size Used for the Test Set and the Data Provenance
The document does not describe a traditional "test set" in the context of an AI/ML device where a dataset is analyzed by the algorithm. Instead, it refers to "Performance testing."
- Sample Size: Not specified. The document states "Performance testing has been conducted," but the number of resins, bleaching materials, or in-vitro/in-vivo tests is not provided.
- Data Provenance: Not specified. The text doesn't explicitly state the country of origin of the test data or whether it was retrospective or prospective.
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 510(k) submission. Dental curing lights are physical devices that cure materials; they do not involve human expert interpretation for establishing ground truth in the way AI/ML devices for image analysis do. The "truth" is based on physical material properties and established dental clinical efficacy.
4. Adjudication Method for the Test Set
Not applicable. There is no mention of an adjudication method as would be used for expert review of data for AI/ML validation.
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. This is not an AI/ML device and therefore no MRMC study involving human readers with or without AI assistance would have been conducted or reported.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device (dental curing light), not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for a dental curing light relates to its ability to effectively cure dental resins and activate bleaching agents without causing harm. The document states that "Performance testing has been conducted that confirms that the halogen light technology used for LED Turbo is able to cure resin and activate tooth bleaching agents within the specified timeframe without causing thermal damage to the tissue."
Therefore, the type of "ground truth" would likely be physical measurements and material science validation (e.g., degree of conversion of resin, color change in bleaching agents, temperature measurements to detect thermal damage).
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device; there is no "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this type of device.
§ 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.