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To remove adherent plaque and food debris from the teeth to prevent tooth decay. To prevent the growth of bacterial between brushings to maintain the cleanliness of the toothbrush.

The Crest Toothbrush with MicroShield is a manual toothbrush consisting of a shaft with synthetic bristles at one end intended to remove adherent plaque and food debris from the teeth to reduce tooth decay. The toothbrush contains an antimicrobial agent to prevent the growth of bacteria on the brush between uses, maintaining the cleanliness of the brush.

The provided text is a 510(k) summary for the Crest Toothbrush with MicroShield. It details the device's purpose, comparison to predicate devices, and regulatory approval. However, it does not contain any information about acceptance criteria or specific study results that prove the device meets these criteria.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and the reported device performance
• Sample size used for the test set and the data provenance
• Number of experts used to establish the ground truth
• Adjudication method
• Multi-reader multi-case (MRMC) comparative effectiveness study
• Standalone performance study
• Type of ground truth used
• Sample size for the training set
• How the ground truth for the training set was established

The document focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and intended use, rather than presenting detailed performance data against predefined acceptance criteria from a study.

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