(275 days)
The dental device is composed by two distinguished and physically connected equipments, that are: dental chair - dental unit (hydro-group) The dental chair is an equipment whose function is to support and position the patient during the dental operations. The dental unit is an equipment connected to the dental chair whose function is to lodge, support and functionally supply the professional instruments used by the dentist and it is combined with accessories. The Continental version can be identified by an instruments table type S.P.R.I.D.O. In this type of table a rod device supports the cord during the activation and the rest of the instrument. The International version can be identified by an instruments table with pending cords. In this type of table resting instruments are hold in specific housings that support them in an almost vertical position, while the cord is pending from the instruments table. The dental device is used by dentist in order to perform dental operations in the dentist's surgery. During the practice and use of the dentist can be helped by an assistant who can use some instruments of the dental unit.
The dental device is composed by two distinguished and physically connected equipments, that are: dental chair - dental unit (hydro-group) The dental chair is an equipment whose function is to support and position the patient during the dental operations. The dental unit is an equipment connected to the dental chair whose function is to lodge, support and functionally supply the professional instruments used by the dentist and it is combined with accessories. The Continental version can be identified by an instruments table type S.P.R.I.D.O. In this type of table a rod device supports the cord during the activation and the rest of the instrument. The International version can be identified by an instruments table with pending cords. In this type of table resting instruments are hold in specific housings that support them in an almost vertical position, while the cord is pending from the instruments table.
This document is an FDA 510(k) clearance letter for a dental operative unit, the "Stern's S250 NordAm" (also referred to as "S250 NordAm"). It does not contain information about acceptance criteria or a study proving that a device (in the context of an AI/software device) meets specific acceptance criteria.
The information provided describes a traditional medical device (a dental chair and unit) and its regulatory clearance process, which focuses on substantial equivalence to a predicate device rather than performance metrics like sensitivity, specificity, accuracy, or reader improvement in an AI context.
Therefore, I cannot provide the requested table and study details. If you have a different document describing an AI/software medical device's performance study, I would be happy to analyze that.
§ 872.6640 Dental operative unit and accessories.
(a)
Identification. A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.(b)
Classification. Class I (general controls). Except for dental operative unit, accessories are exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.