(169 days)
The Vanguard Dental Unit is intended to supply power to and serve as a base for dental devices; and accessories. It is intended for use in the dental clinic /office environment and used by trained dentists and/or dental technicians and assistants. This product is attached with a dental chair.
Not Found
The provided document is a 510(k) premarket notification letter from the FDA for a dental unit. It does not contain any information about acceptance criteria or a study proving that an AI/ML device meets those criteria.
The document solely focuses on:
- Device: Vanguard Dental Unit
- Regulation Number: 21 CFR 872.6640 (Dental Operative Unit and Accessories)
- Regulatory Class: Class I
- Product Code: EIA
- FDA Determination: Substantially equivalent to legally marketed predicate devices.
- Indications for Use: To supply power to and serve as a base for dental devices and accessories, intended for use in dental clinics/offices by trained personnel, and attached to a dental chair.
Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment for an AI/ML device.
§ 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.