(68 days)
Triton is used for debridement, removing the smear layer, and cleansing the root canal system.
Triton is a two-part, dual-action root canal cleanser. Triton Part A is an aqueous solution that contains carboxylic acid chelating agents and surfactants. Triton Part B is an aqueous solution that contains sodium hypochlorite. Once the two solutions are mixed solution cleanses and debrides the root canal system by removing the organic debris during and after endodontic instrumentation.
This document is an FDA 510(k) clearance letter for a dental device called Triton. It primarily addresses the substantial equivalence of Triton to a previously cleared predicate device, V-Mix. It is not a study report detailing clinical performance or acceptance criteria for a new AI/medical imaging device.
Therefore, the provided text does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria, especially in the context of an AI-powered or medical imaging device. The device in question, Triton, is a root canal cleanser, and the clearance is based on its chemical composition being identical to a predicate device, with only changes in packaging and shelf-life, which were supported by non-clinical testing.
There is no information in this document to populate the requested table or answer the specific questions about AI/imaging device study methodologies.
To answer your request, I would need a different type of document, such as a clinical study report for an AI/imaging device submission.
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