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The devices claimed hereis are the air turbines only, and are not the handpiece itself.

The devices are intended for use in the Miwest's Quiet-Air or Tradition handpieces, in place of Midwest's original turbines.

The device, therefore, is, with Midwest handpiece, intended for use in general dental applications; such as cutting a tooth for crown preparation, cavity preparation, finishing the crown, inlay or the filling, etc.

NSK Pushbutoon Autochuck Replacement Turbine. The devices claimed hereis are the air turbines only, and are not the handpiece itself.

The provided document is a 510(k) clearance letter from the FDA for a dental turbine. It is a regulatory approval document and does not contain information about acceptance criteria or a study proving device performance as would be found in a clinical trial report or a detailed technical submission.

Therefore, I cannot extract the requested information from the provided text. The document confirms that the "NSK Push-Button Midwest Replacement Turbine" is substantially equivalent to legally marketed predicate devices and outlines the indications for use. It does not include data on acceptance criteria, device performance, sample sizes for testing or training, expert qualifications, or ground truth methodologies.

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