(84 days)
Dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to teeth.
Not Found
This is a 510(k) clearance letter for a dental scaler, which relies on demonstrating substantial equivalence to a predicate device rather than presenting a de novo clinical study with acceptance criteria and performance data in the format of AI/ML device submissions. Therefore, the detailed information requested regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment, which are typical for AI/ML device studies, is not present in this document.
The document primarily states that the device is substantially equivalent to legally marketed predicate devices for dental cleaning and periodontal therapy to remove calculus deposits from teeth. There is no information in this document about specific performance metrics or a study demonstrating the device meets those metrics.
Therefore, I cannot provide the requested information from the given text as it does not contain the type of study data and acceptance criteria found in submissions for novel or AI/ML-based devices.
§ 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.