(196 days)
The R7 Dental System and accessories are in general dental applications by providing the dental practitioner a user interface to control operation of the dental charted dental devices. The system delivers air, water, vacuum and electricity to allow the dental practitioner an intuitive control common and normal patient treatment procedures, including use of an ultrasonic scaler, performed in the dental operatory.
The R7 Dental System and accessories are in general dental applications by providing the dental practitioner a user interface to control operation of the dental charted dental devices. The system delivers air, water, vacuum and electricity to allow the dental practitioner an intuitive control common and normal patient treatment procedures, including use of an ultrasonic scaler, performed in the dental operatory.
This document is a 510(k) premarket notification from the FDA for the R7 Dental System. It primarily concerns the administrative approval of a medical device, confirming its substantial equivalence to a predicate device.
Unfortunately, the provided text does not contain the detailed clinical study information needed to describe acceptance criteria or the study that proves the device meets those criteria. The document is a regulatory approval letter and an "Indications for Use" statement, not a scientific or clinical study report.
Therefore, I cannot provide the requested information in the table format or answer the specific questions about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.
The document states:
- Trade/Device Name: R7
- Regulation Number: 21 CFR 872.4850
- Regulation Name: Ultrasonic Scaler
- Regulatory Class: II
- Product Code: ELC, EIA
- Indications for Use: "The R7 Dental System and accessories are in general dental applications by providing the dental practitioner a user interface to control operation of the dental charted dental devices. The system delivers air, water, vacuum and electricity to allow the dental practitioner an intuitive control common and normal patient treatment procedures, including use of an ultrasonic scaler, performed in the dental operatory."
This indicates the device's function and intended use, but not the performance metrics or study results that would be used to establish equivalence or performance.
To answer your request, I would need a different type of document, such as a summary of safety and effectiveness (SSE), a clinical study report, or a detailed 510(k) submission document that includes performance data.
§ 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.