(46 days)
The DentaSeptic HPC device is intended as a single use, disposable, transparent, plastic, disposable, non-sterile protective cover to be placed over various high speed and low speed dental handpieces used in the dental/ clinical setting. The cover acts as a physical barrier that assists in providing surface protection for the handpieces, reducing cross contamination of equipment, augmenting existing infection control techniques and making clean up and disinfection less time consuming.
The DentaSeptic HPC device is a disposable plastic cover that is made of high density polyethylene (HDPE), that fits over the ends of various high speed and low speed dental handpieces used in the dental/ clinical setting. The cover allows for the attachment and/or protrusion, where applicable, of those parts of the devices that are inserted into the patient's mouth.
This looks like a 510(k) premarket notification for a medical device called DentaSeptic HPC, a disposable cover for dental handpieces. The document is a submission to the FDA, not a study report. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria, study details, expert qualifications, or ground truth establishment.
A 510(k) submission primarily demonstrates substantial equivalence to a legally marketed predicate device rather than providing extensive clinical study data with acceptance criteria in the manner you've described for AI/ML device evaluations. Such submissions often rely on bench testing, material safety, and performance comparisons to predicates, not typically large-scale human-centric studies.
Therefore, I cannot provide the requested information based on the provided text.
§ 872.4200 Dental handpiece and accessories.
(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.