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Used in general dentistry and endodontic dentistry for cutting, shaping, filing, drilling, cleaning and polishing procedures

The eSTYLUS™ ELECTRIC MOTOR SYSTEM is an electric motor driven dental handpiece system with various attachments, intended for use in general and endodontic dentistry. The System includes the electric motor, control unit, AC power supply, connector hose, and contra-angle and straight attachments.

The provided text is a 510(k) summary for the eSTYLUS™ ELECTRIC MOTOR SYSTEM, which is an electric motor driven dental handpiece system. The document states that the device is substantially equivalent to predicate devices based on "comparison and performance data provided, and the testing conducted." However, it does not provide specific details about the acceptance criteria or the study that demonstrates the device meets these criteria.

Therefore, I cannot extract the requested information regarding:

• 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
• Qualifications of those experts
• Adjudication method
• MRMC comparative effectiveness study
• Standalone performance
• 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 establishing substantial equivalence to predicate devices based on intended use, basic technology, primary energy source, and materials, rather than detailing a specific performance study with acceptance criteria.

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