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The intended use of the FixaFloss is to be placed between teeth for the fixation of rubber dams.

The FixaFloss is a waxed dental floss with a silicone conical clamping element intended to be placed between teeth for rubber dam fixation.

The FixaFloss is a waxed dental floss assembled with 1 size and 1 color silicone conical resilient clamping element packaged as a one string product containing 20 resilient connes in a hygienic dispenser with an integrated cutting blade.

The provided text is a 510(k) summary for the FixaFloss device, a waxed dental floss with a silicone conical clamping element intended for rubber dam fixation. However, it does not contain the detailed information necessary to answer your request about acceptance criteria and a study proving the device meets those criteria.

This document is a regulatory submission focused on demonstrating substantial equivalence to a legally marketed predicate device (The Hygenic Corp., Wedjets). It describes the device, its intended use, and claims substantial equivalence, but it does not present:

• A table of acceptance criteria.
• Reported device performance against specific criteria.
• Details of any study (sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth).
• Information on training sets.

Therefore, I cannot fulfill your request based on the provided text. The document's purpose is to clear the device for market by showing it is similar to an existing product, not to publish detailed performance study results against specific criteria.

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