(76 days)
The Planmeca Intracam Station intra oral video camera system is intended for use by practitioners in the dental field for use as an aid or adjunct to assist in viewing intra oral anatomies and capturing and storing images for later retrieval. The camera interfaces with video printers, TV/monitors, capture boards etc. The Intracam Station is an independent system, i.e. it can be used separate from a dental unit.
Planmeca Intracam Station intra oral video camera system
I am sorry, but the provided text from the FDA 510(k) clearance letter for the Planmeca Intracam Station does not contain the information requested regarding acceptance criteria and details of a study proving device performance.
The letter is a standard FDA clearance document, which:
- Confirms substantial equivalence to a predicate device.
- States the indications for use.
- Outlines general regulatory requirements.
It does not include:
- A table of acceptance criteria.
- Reported device performance metrics (e.g., sensitivity, specificity, accuracy).
- Details about a specific study (sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance).
- Information about training sets.
Therefore, I cannot fulfill your request based on the provided input.
§ 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.