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Triumph Resin Dam is a resin-based, light-cured protective barrier material recommended to protect dental materials or tissues. For Use only by a Licensed Dentist. Rx Use Only.

Triumph Resin Dam is a light-cured, resin dam material recommended to block out or protect dental materials or tissues. Triumph contains polymerizable monomers that when light-cured form a protective barrier. When set the resin has a low strength allowing its removal from the protected surfaces.

This document is a 510(k) summary for a medical device called "Triumph Resin Dam," which is a resin-based, light-cured protective barrier material for dental use. The summary focuses on demonstrating substantial equivalence to a predicate device ("OpalDam") rather than presenting a study proving performance against acceptance criteria in the typical sense of a clinical trial for diagnostic AI.

However, I can extract the relevant information from the document to construct an answer aligned with your request, interpreting "acceptance criteria" as the criteria for demonstrating substantial equivalence and "study" as the comparison tests performed.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

For this type of device (a Class I dental resin dam), the "acceptance criteria" are essentially the characteristics and performance deemed equivalent to a legally marketed predicate device. The document primarily focuses on demonstrating substantial equivalence to the Opal Dam (K971284) and referencing BriteSmile (K010935) for hardness comparison.

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