(242 days)
Dr's Light 2 is a hand held LED polymerization light intended to cure dental composites using visible light.
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This document, K173157, is a 510(k) premarket notification for a dental device called "Dr.'s Light 2." It is a regulatory approval letter from the FDA. Based on the provided text, there is no information about acceptance criteria for a study, performance metrics, sample sizes, expert qualifications, or any details related to an AI/algorithm-based medical device study.
The document states that the device is a "hand held LED polymerization light intended to cure dental composites using visible light." This is a physical, light-emitting device, not a software or AI-driven diagnostic or analytical tool that would typically involve the kind of studies you are asking about (e.g., MRMC, standalone algorithm performance, ground truth establishment through expert consensus or pathology).
Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving the device meets them, as the provided input does not contain any of that information. The document is solely an FDA clearance letter for a non-AI dental light.
§ 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.