(90 days)
This Device is to be used by a Dentist or A Dental Hygienist for cleaning procedures on teeth.
Disposable Prophy Angle
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves a device meets such criteria.
The document is an FDA 510(k) clearance letter for a device called "Disposable Prophy Angle Project's 020,021." This letter confirms that the FDA has reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices.
The letter explicitly states that the FDA's issuance of a substantial equivalence determination "does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies." It focuses on regulatory compliance rather than performance data or study results.
Therefore, I cannot provide the requested table or answer the specific questions about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.
§ 872.4200 Dental handpiece and accessories.
(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.