(207 days)
BlueLEX LED Curing Light LD-109 is for the polymerization of light cure materials.
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The provided document is a 510(k) premarket notification letter from the FDA for a dental curing light, the BlueLEX LED Curing Light LD-109. This type of document primarily confirms that a new device is substantially equivalent to existing legally marketed devices. It does not typically contain detailed information about specific acceptance criteria or studies proving device performance beyond confirming substantial equivalence for its stated indications for use.
Therefore, most of the information requested in your prompt (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, details of comparative effectiveness studies, standalone performance, ground truth types, and training set information) is not available in this document.
Here's what can be extracted:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in this document. Substantial equivalence to a predicate device is the overarching acceptance criterion for a 510(k) clearance.
- Reported Device Performance: The device is indicated for "polymerization of light cure materials." The letter indicates substantial equivalence, implying its performance is comparable to legally marketed predicate devices for this function. Specific performance metrics (e.g., light intensity, curing depth, curing time) are not detailed here.
2. Sample sized used for the test set and the data provenance
- Test Set Sample Size: Not provided.
- Data Provenance: Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided in a 510(k) clearance letter.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not provided in a 510(k) clearance letter.
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
- MRMC Study: No. This device is a dental curing light, not an AI-assisted diagnostic tool for human readers.
- Effect Size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable as this is a physical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The concept of "ground truth" as typically applied to diagnostic or AI studies is not relevant here for a dental curing light. The performance would likely be evaluated against physical standards or performance of predicate devices.
8. The sample size for the training set
- Not applicable/Not provided.
9. How the ground truth for the training set was established
- Not applicable/Not provided.
§ 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.