(44 days)
NEW OUTLINE is a resin used by dentists and dental technicians to fabricate temporary crowns and bridges.
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The provided text is a 510(k) premarket notification letter from the FDA regarding a dental device called "NEW OUTLINE," a temporary crown and bridge resin.
This document does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC studies for AI/algorithm-based devices.
The letter is a regulatory approval document confirming substantial equivalence to a predicate device, which is a different type of assessment than what is typically requested for AI/machine learning device evaluations. It does not describe any studies involving algorithms or AI, nor does it provide performance metrics in the format of acceptance criteria or reported device performance.
Therefore, I cannot fulfill your request for the information outlined in your prompt based on the provided text.
§ 872.3770 Temporary crown and bridge resin.
(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.