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The dental delivery system is a device intended to support the instruments used by the dental practitioner, delivering those instruments to an accessible position during a dental procedure. This device may control and be the means of delivering compressed air, water, vacuum and low voltage electricity to a variety of instruments commonly used in dental practice.
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The provided text is a 510(k) clearance letter from the FDA for a Dental Delivery System Series 5 and 5 Plus.
This document does not contain any information about acceptance criteria or a study proving the device meets those criteria.
The 510(k) letter primarily addresses the substantial equivalence of the device to legally marketed predicates and outlines regulatory requirements. It does not delve into specific performance metrics, clinical study design, or ground truth establishment for a medical device that relies on diagnostic performance (like an AI algorithm).
Therefore, based solely on the provided text, it is impossible to answer the questions regarding acceptance criteria and the study that proves the device meets them. The device described (Dental Delivery System Series 5 and 5 Plus) is a physical piece of dental equipment, not a diagnostic algorithm or AI software for which the requested performance metrics and study details would be relevant.
To answer your questions, I would need a different type of document, such as a summary of safety and effectiveness data for a diagnostic device, or a clinical study report.
§ 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.