(159 days)
The Sonendo Endotherapy System is intended to prepare, clean and irrigate 1st and 2nd molar teeth indicated for root canal therapy.
The Sonendo Endotherapy System is a medical device intended to prepare, clean and irrigate root canals. The Sonendo Endotherapy System is comprised of a Console, Foot Pedal and Molar Procedure Kit with a Handpiece.
The provided text describes the Sonendo Endotherapy System and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a specific study proving the device meets acceptance criteria in the format requested.
The document states that "All necessary performance testing has been conducted for the Sonendo Endotherapy System to assure substantial equivalence to the predicate devices and demonstrate the devices perform as intended." It then lists the types of testing performed:
- Simulated Use
- EMC and Electrical Safety
- Thermal Safety
- Hydroacoustics
- Apical Extrusion and Pressure
- Cleaning
However, it does not provide details on:
- A table of acceptance criteria and reported device performance
- Sample sizes used for the test set and data provenance
- Number of experts used to establish ground truth and their qualifications
- Adjudication method
- Multi-reader multi-case (MRMC) comparative effectiveness study results or effect size
- Stand-alone algorithm performance
- Type of ground truth used
- Sample size for the training set
- How ground truth for the training set was established
The document focuses on establishing substantial equivalence based on intended use, principle of operation, and technological characteristics, rather than reporting detailed performance against specific acceptance criteria.
§ 872.4850 Ultrasonic scaler.
(a)
Identification. An ultrasonic scaler is a device intended for use during dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.(b)
Classification. Class II.