(171 days)
LEDEX (Family model: WL-090, WL-090+) is a visible curing unit programmed for polymerization of dental light cured materials by dental professionals.
Not Found
The provided document is a 510(k) premarket notification letter from the FDA for a dental light curing unit (LEDEX WL-090 and WL-090+). This type of document does not typically contain detailed information about acceptance criteria and the specifics of a study proving device performance in the way requested.
The letter primarily states that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has similar indications for use and technological characteristics to an existing device. The FDA's review for substantial equivalence generally relies on a comparison to predicate devices rather than requiring new, extensive performance studies with detailed acceptance criteria and ground truth establishment as would be expected for a novel AI/software medical device.
Therefore, most of the requested information cannot be extracted from this document, as it pertains to a different type of device and regulatory review process.
However, I can extract the following limited information:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for a study. The acceptance criterion from the FDA's perspective is "substantial equivalence" to a predicate device.
- Reported Device Performance: Not detailed in a study format within this document. The device is described as a "visible curing unit programmed for polymerization of dental light cured materials." Its performance is implicitly considered sufficient because it was found substantially equivalent to existing devices that perform this function.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This document does not describe a clinical performance study with a test set.
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)
- Not Applicable. This document does not describe a clinical performance study requiring ground truth establishment by experts.
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 device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI/algorithm device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable.
8. The sample size for the training set
- Not Applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable.
In summary, the provided document is an FDA 510(k) clearance letter for a dental light curing unit, not a study report for an AI/software medical device. As such, the detailed information regarding acceptance criteria, study design, ground truth establishment, and expert involvement that you've requested is not present in this type of regulatory correspondence.
§ 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.