(42 days)
This Blue Luxcer, Curing Light is a visible curing unit programmed for polymerization of light cured materials by dental professionals.
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This document does not contain the specific information required to complete the request. The provided text is a 510(k) summary for a dental curing light, and while it indicates that performance testing was done to validate the device's performance for substantial equivalence to a predicate device, it does not provide details about:
- Acceptance criteria: What specific performance metrics (e.g., light intensity, curing depth, curing time) were used as acceptance criteria.
- Reported device performance: The actual quantitative results of the performance tests against those criteria.
- Study design details: Sample sizes, data provenance, ground truth establishment methods, expert qualifications, or adjudication methods for any studies.
- Comparative effectiveness studies (MRMC): There's no mention of a study involving human readers or their improvement with AI assistance. This device is not an AI-powered diagnostic tool.
- Standalone algorithm performance: This device is a curing light, not an algorithm.
The document primarily focuses on establishing substantial equivalence to a predicate device based on intended use, technological characteristics, and a general statement about performance testing. It does not provide the detailed scientific study results typically found in a clinical trial report or a comprehensive validation study.
Therefore, I cannot populate the table or answer the specific questions based on the provided text.
§ 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.