(78 days)
The C-U2 is a digital intraoral camera system specifically designated for easy intraoral dental examinations, with an extremely lightweight handpiece, automatic brightness adjustment and fixed focus. It is conceived to assist the dentist during the day-by-day communications with the patient, to explain the treatment and to improve the patient's awareness.
The C-U2 is a digital intraoral camera system specifically designated for easy intraoral dental examinations, with an extremely lightweight handpiece, automatic brightness adjustment and fixed focus.
The provided text is a 510(k) clearance letter from the FDA for a dental operative unit and accessories (C-U2). It does not contain any information about acceptance criteria or a study proving the device meets those criteria, nor does it discuss device performance metrics, sample sizes, ground truth establishment, or any AI-related studies.
The letter essentially states that the FDA has reviewed the premarket notification and determined the device is "substantially equivalent" to legally marketed predicate devices. This means it has met the regulatory requirements for market clearance based on its equivalence to existing products, not necessarily through a detailed performance study with specific acceptance criteria as might be expected for novel AI-powered devices or those requiring a PMA.
Therefore, I cannot fulfill your request for the detailed information you've asked for, as it is not present in the provided document.
To summarize the requested points in relation to the provided text:
- A table of acceptance criteria and the reported device performance: Not present in the document.
- Sample sized used for the test set and the data provenance: Not present in the document.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present in the document.
- Adjudication method for the test set: Not present in the document.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not present in the document. The device is an intraoral camera, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not present in the document. The device is an intraoral camera, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not present in the document.
- The sample size for the training set: Not present in the document.
- How the ground truth for the training set was established: Not present in the document.
§ 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.