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The Viola II Dental Camera system is designed for use in the following applications:

1. To allow the clinician to provide the patient with accurate information
2. To allow the clinician to provide educational information to the patient as well as other clinical personnel
3. To provide documentation for patient records
4. To assist the clinician in the diagnosis of oral cancer and gum diseases
5. To provide documentation for insurance companies

Not Found

This document is a 510(k) premarket notification for the "Viola II Dental Camera System" and mainly discusses regulatory approval based on substantial equivalence to a predicate device. It does not contain detailed information about acceptance criteria or a specific study proving the device meets acceptance criteria.

Therefore, I cannot extract the requested information as it is not present in the provided text. The document is a regulatory approval letter and an indications for use statement, not a performance study report.

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