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To be used for cleaning and polishing procedures as part of a professionally administered dental prophylaxis treatment.

The Double-Pro™ Prophylaxis Paste with Fluoride family of devices, manufactured by Professional Dental Technologies Therapeutics, Inc., are oral cavity abrasive polishing agents that contain fluoride, an abrasive (in one of several available levels of grit courseness), a swectener, water, flavoring, color, thickeners, and preservatives. Double-Pro™ is intended for use by dental professionals, during professionally administered dental prophylaxis treatment (tooth-cleaning), to polish and clean calculus, stains, and other accretions from the teeth. Double Pro™ prophy paste is applied to patients' teeth with a prophy angle and rotating rubber cup. Use of Double-ProTM Prophylaxis Paste with Fluoride family of devices is to be limited to individuals who are professional trained to perform dental prophylaxis.

The provided text is a 510(k) summary for a dental prophylaxis paste and does not contain information about acceptance criteria or a study proving that a device meets such criteria in the context of an AI/software device.

This document is for "Pro-Dentec's Double-Pro™ Prophylaxis Paste with Fluoride Family of Devices," which is a physical dental product, not a software or AI device. The summary focuses on demonstrating substantial equivalence to a predicate device (NUPRO® Prophylaxis Paste with Fluoride).

Therefore, I cannot extract the requested information points (acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) because they are specific to the evaluation of AI/software medical devices, which is not what this document describes.

The document primarily states:

• Intended Use: Cleaning and polishing procedures as part of a professionally administered dental prophylaxis treatment.
• Substantial Equivalence Argument: The device is substantially equivalent to a predicate device (NUPRO® Prophylaxis Paste with Fluoride) based on similar ingredients, fluoride concentration (1.23% +/- 10% fluoride release identical to NUPRO®), intended use, and application method.

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