(76 days)
The A-dec Delivery System is intended to provide a mounting location to providing arr, water, vacuum, and electrical power to dental devices for use during diagnostic treatment by licensed health care professionals. Delivery systems may be mounted to dental carts, dental cabinets, and walls.
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I'm sorry, but this document does not contain the information requested in your prompt. The document is an FDA 510(k) clearance letter for the A-dec 300 and A-dec 500 Delivery Systems, which are dental operative units.
The letter discusses regulatory classifications, general controls, and compliance requirements for these devices. It also includes an "Indications for Use" section.
However, the document does not describe any AI/device performance study, acceptance criteria, or related data such as sample sizes, expert qualifications, ground truth establishment, or MRMC studies. The device cleared is a dental operative unit and accessories, not an AI-powered diagnostic or assistive device that would typically undergo the type of performance studies you are asking about.
§ 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.