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The Plaque Scraper-A Interproximal (between teeth) Plaque Remover is an effective cleansing device which removes plaque and food between the teeth as part of a program for good oral hygiene to supplement the regular professional care required for oral health. This product is intended for personal oral hygiene use.

The Plaque Remover is a plastic product designed with an elongated handle for ergonomic convenience and has dual rounded and beveled points on each end.

The provided text is a 510(k) summary for the "Plaque Scraper-A Interproximal (between teeth) Plaque Remover." This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific performance acceptance criteria and results from a clinical trial.

Therefore, the requested information elements such as acceptance criteria, reported device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance studies, and types of ground truth cannot be extracted from this document, as they are not present.

The summary states:
"The information in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to devices already in commercial distribution. Equivalence is demonstrated through intended use, materials and design."

This indicates that the submission relies on a comparison of intended use, materials, and design features to establish substantial equivalence with a legally marketed predicate device (Reach Stim-U-Dent Plaque Remover), rather than providing performance data from a specific study against predefined acceptance criteria.

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