(156 days)
The Logos Junior dental unit and accessories are indicated for the provision of dental treatment in the dental operatory by dentists, dental assistants and dental hygienists.
LOGOS JUNIOR DENTAL CHAIR AND UNIT
The provided document is a 510(k) clearance letter from the FDA for a dental chair and unit (Logos Junior Dental Chair and Unit, K023513). This document is not a study report for an AI/ML medical device. Therefore, it does not contain the information required to answer the questions about acceptance criteria, device performance, study design, or ground truth establishment for such a device.
The letter explicitly states that the device is a "Dental Operative Unit and Accessories" and its indication for use is "for the provision of dental treatment in the dental operatory by dentists, dental assistants and dental hygienists."
To answer your questions, I would need a different type of document, specifically a study report or clinical validation report for an AI/ML medical 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.