(49 days)
The EXPEDITION offers the dental professional the capability of carrying a complete dental operative system in one transportable case. The system is suitable for performing general dental procedures anywhere there is a suitable surface to contain and be operated on internal power source. Additionally, the internal power source can be recharged using a detachable solar panel.
The AEU-14CF Expedition is a portable electric dental system intended to provide basic dentistry capabilities in emergency and field situations. The Expedition features an "E" type autoclavable 30,000 RPM brushless micro motor with interchangeable headpieces, a 3-way air/water syringe, a self-contained water system, and an oil-less air compressor. The Expedition is powered by internal 27.6V battery packs, and may be connected to a 120V/230V AC power source or to a 12/24V vehicle battery for extended operation or recharging. A detachable solar panel is also provided for recharging the internal batteries when other sources are not available.
This document is a 510(k) Summary for the AEU-14CF Expedition Field Dental System. It lists the device description, features of substantial equivalence to a predicate device (Aseptico Model AEU-425, K022217), and other features. An FDA letter of substantial equivalence is also provided.
However, the provided text does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them because the necessary information is absent from the provided document.
The document primarily focuses on demonstrating substantial equivalence to a predicate device, which is a regulatory pathway for medical devices in the United States, and does not require explicit performance study data against defined acceptance criteria in the same way a new device with novel technology might.
§ 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.