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Silgimix™ is indicated for use as a dental impression material. The material is intended primarily for taking impressions for study models, orthodontic models, counter impressions, partial denture impressions and temporary crown fabrication.

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This document is a 510(k) clearance letter for a dental impression material named Silgimix®. As such, it does not contain the kind of detailed study information (acceptance criteria, sample sizes, ground truth establishment, expert qualifications, etc.) that would be found in a clinical study report for an AI/ML medical device.

The FDA's 510(k) clearance process for devices like this typically relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials with the specific metrics you've requested for AI device studies.

Therefore, I cannot provide the requested information because it is not present in the provided document. The document primarily focuses on regulatory clearance and the device's intended use.

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