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510(k) Data Aggregation
(44 days)
DOCTOR'S LIGHT LED DENTAL CURING LIGHT
Curing of dental composites using visible light.
Doctor's Light LED Dental Curing Light is a hand-held polymerization light intended for use in curing dental composites. This product uses a rechargeable Li-ion Battery for cordless operation.
The provided text is a 510(k) summary for a dental curing light, which is a physical device, not an AI/ML algorithm. Therefore, many of the requested categories for AI/ML device studies, such as sample sizes for test/training sets, expert adjudication, MRMC studies, and ground truth establishment, are not applicable.
Here's an analysis of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Electrical Safety (IEC 60601-1) | Meets standard |
| Electromagnetic Compatibility (IEC 60601-1-2) | Meets standard |
| Performance Specifications | Bench testing demonstrated compliance |
| Equivalence to Predicate Devices: | |
| - Light source | Equivalent to predicate devices |
| - Power source | Equivalent to predicate devices |
| - Wavelength | Equivalent to predicate devices |
| - Materials | Equivalent to predicate devices |
| - Light intensity | Equivalent to predicate devices |
| - Peak wavelength | Equivalent to predicate devices |
| - Depth of cure | Equivalent to predicate devices |
2. Sample size used for the test set and the data provenance
Not applicable for this type of device and submission. The performance was assessed through bench testing and comparison to predicate devices, not through a data-driven test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth establishment with experts is relevant for diagnostic or AI/ML devices, not for a dental curing light whose performance is determined by physical characteristics and safety standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a standalone physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" equivalent for this device type would be the established scientific and engineering principles for dental curing lights, as well as the specifications of the predicate devices. Performance was verified against these benchmarks and relevant industry standards (IEC 60601-1, IEC 60601-1-2).
8. The sample size for the training set
Not applicable. There is no training set for a dental curing light.
9. How the ground truth for the training set was established
Not applicable.
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