(18 days)
The Planmeca IntraCam intra oral video camera is a dental operative unit accessory, which 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., and is designed to be located as an instrument in a dental unit.
The Planmeca IntraCam intra oral video camera is a dental operative unit accessory. The camera interfaces with video printers, TV/monitors, capture boards etc., and is designed to be located as an instrument in a dental unit.
The provided document is a 510(k) premarket notification letter from the FDA for a device called "Planmeca Intracam" in 1997. This type of regulatory document typically does not contain the detailed study information requested, such as specific acceptance criteria for performance metrics, sample sizes, ground truth establishment, or expert qualifications for studies.
Therefore,Based on the provided document, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample sizes and data provenance for a test set.
- Number and qualifications of experts for ground truth.
- Adjudication method for the test set.
- Results of a multi-reader multi-case (MRMC) comparative effectiveness study, including effect size.
- Results of a standalone (algorithm-only) performance study.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This document is a marketing clearance letter, not a detailed technical report of a clinical or performance study. It states that the device is "substantially equivalent" to predicate devices, meaning it has met the regulatory requirements for marketing based on a comparison to existing, legally marketed devices. It does not elaborate on the specific performance studies that might have been conducted to demonstrate this equivalence in terms of quantitative metrics.
§ 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.