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Ultrasonic Scaler is used to remove dental plaque from teeth and remove stains on teeth during dental cleaning.

A device intended for use during dental cleaning and periodontal (gum) therapy to remove adherent plaque and food debris from the teeth to reduce tooth decay, potential stains in the gingival groove, the back of the tooth and the tooth and associated gingival line. The electronic oscillation circuit generates ultrasonic frequency electric pulse wave, which is amplified to a certain intensity and conveyed to the transducer. The electrical energy is converted into mechanical energy, and the working head tool is stimulated to produce vibration of the same frequency, so as to achieve the purpose of crushing calculus and loosening tartar.

The provided text is a 510(k) summary for an Ultrasonic Scaler (K240707). It describes the device's substantial equivalence to a predicate device and outlines performance data. However, it does not contain the acceptance criteria or a study that proves the device meets those criteria in the context of AI/ML performance.

Instead, the document focuses on:

• Comparison of technological characteristics between the proposed device and a predicate device (K163414). This comparison highlights similarities and differences in design, operation controls, power supply, operating conditions, storage conditions, and electrical/EMC/biocompatibility standards.
• Performance data limited to biocompatibility testing and non-clinical testing of electrical safety and electromagnetic compatibility (EMC) according to various IEC standards.

Therefore, I cannot provide the requested information regarding acceptance criteria for an AI/ML device, its reported performance, sample sizes, ground truth establishment, or specific AI/ML study details, because this information is not present in the provided document.

The document discusses acceptance criteria and performance data for a physical medical device (ultrasonic scaler), not an AI/ML component.

If this was a misunderstanding and you were expecting information related to a traditional medical device's performance, please clarify. Otherwise, the requested AI/ML specific information is absent from this document.

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