(47 days)
The AirFlow handy is a dental handpiece intended for use in the cleaning and polishing of teeth by the projection of water, air, and bicarbonate powder onto the tooth surface. The device removes soft deposits and areas of discoloration and can be used to clean teeth prior to dental procedures which require a clean tooth surface such as the placement of composite fillings, inlays, and laminate veneers. The device can also be used to clean the following: - implant abutments and teeth prior to treatments such as shade matching, fluoridation, and bleaching - crowns and bridges - fixed bands and brackets prior to placement on orthodontic appliances.
The AirFlow handy is a hand-held device containing air and water lines, powder chamber, and powder inflow nozzle. The device connects to a standard turbine tube which supplies air and water. When the AirFlow handy is connected to the tube which supplies air and water and the turbine is activated, an air/powder stream enveloped by a water spray is generated which can be directed onto the tooth surface for cleaning and polishing.
I am sorry, but the provided text does not contain a study that proves the device meets specific acceptance criteria. The document is a 510(k) summary for a dental handpiece, AirFlow handy. It describes the device, its intended use, and its technological characteristics in comparison to predicate devices.
Section 7, titled "PERFORMANCE TESTING," mentions that "Testing was performed to support a minimal reuse life of 130 treatments, which corresponds to 15 hours of use. Connection-integrity testing demonstrated that the connection between the turbine adaptor and the dental unit remained intact when subjected to air pressures of 10 bar."
However, this section describes the testing performed but does not report the specific acceptance criteria for these tests, nor does it provide detailed results or a full study proving that the device met those (unspecified) criteria. It simply states that testing was performed to support certain claims and that connection-integrity testing "demonstrated" a certain outcome, without providing the quantitative acceptance limits or the exact results obtained.
Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document, nor can I answer questions about sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, types of ground truth, or details about the training set, as this information is not present in the provided text.
§ 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.