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Used for ultrasonic procedures: 1) All general supra and subgingival scaling applications; 2) Periodontal debridement for all types of periodontal diseases; and 3) Endodontic procedures.

The Modified Device, the Model G131 consists of the Cavitron RF Product, and the applicable model families of Cavitron 30K Ultrasonic Inserts. The Model G-131 Cavitron RF Utrasonic Scaler with Sterimate handpiece is a 30K ultrasonic dental device that provides an electromagnetic field, pulsed at 30 kilohertz (KHz) through the length of the handpiece. When a magnetostrictive insert, designed to resonate near 30kHz is placed in the length of the handpiece it will vibrate at the designed resonance which in turn excites the insert tip, causing it to move in reciprocal motion. The system operates over a frequency range working near 30KHz. The input voltage of the Scaler is 100 - 240 VAC, 50 to 60 Hz.

This 510(k) summary for the DENTSPLY CAVITRON® RF Ultrasonic Scaler System (K052334) does not provide the acceptance criteria or a study proving the device meets those criteria.

The document is a premarket notification for a medical device seeking clearance based on substantial equivalence to a predicate device. It focuses on device description, intended use, and technological characteristics compared to the predicate, but it does not contain the detailed performance study information requested.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer the questions about sample size, data provenance, ground truth establishment, or clinical study specifics.

The document indicates that the device is an "Ultrasonic scaler 872.4850" and that the predicate device is the "DENTSPLY Cavitron SPS Scaler System, Model G-119 (K970123)". To establish substantial equivalence for this type of device, the manufacturer would typically demonstrate that the new device performs as safely and effectively as the predicate device. This would usually involve bench testing and potentially limited clinical testing to show comparable performance characteristics (e.g., ultrasonic vibration frequency, power output, flow rates, tip stroke, efficacy of calculus removal, patient safety, and comfort). However, these details are not present in the provided 510(k) summary.

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