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intended for use during dental and periodontal therapy treatments to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.

an ultrasonic scaler intended for use during dental and periodontal therapy treatments to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.

This document (K964596) is a 510(k) premarket notification for an ultrasonic scaler, a device used in dentistry to remove calculus. It does not contain any information about acceptance criteria, device performance metrics (like accuracy, sensitivity, specificity), data provenance, expert ground truth, or details of a study involving AI or human readers.

The document primarily focuses on establishing "substantial equivalence" of the new device (Pro-Select3™) to existing predicate devices (like Dentsply's Cavitron® Ultrasonic 3000) for the purpose of regulatory approval. This type of submission typically demonstrates that the new device has the same intended use and similar technological characteristics, and does not raise new questions of safety or effectiveness, without necessarily providing detailed performance studies in the way you've outlined for AI/ML device evaluations.

Therefore, I cannot provide the requested table and study details based on the provided text. The document is for a traditional medical device and does not involve the type of performance evaluation typically associated with AI/ML systems.

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