(75 days)
The SplatrFree Swangle 360 Disposable Prophy Angle is to be used during a prophylaxis treatment to polish the tooth surfaces of a patient.
Not Found
The provided text describes a 510(k) premarket notification for a medical device called the "SplatrFree Swangle 360 Disposable Prophy Angle." This document is a letter from the FDA informing the manufacturer that their device is substantially equivalent to legally marketed predicate devices.
However, the provided text does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies related to the device. The document is strictly an FDA clearance letter based on substantial equivalence to a predicate device, which for Class I general controls devices often means the regulatory burden for clinical performance data is minimal or non-existent in the 510(k) submission itself.
Therefore, I cannot fulfill your request for the specific details outlined in your prompt based on the provided text. The document focuses on regulatory clearance, not on a detailed scientific study demonstrating performance against specific criteria.
§ 872.6510 Oral irrigation unit.
(a)
Identification. An oral irrigation unit is an AC-powered device intended to provide a pressurized stream of water to remove food particles from between the teeth and promote good periodontal (gum) condition.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.