(203 days)
This dental operating unit system is intended for use by professionally trained demists and their supervised dental hygienists and assistants to support their general, nonsurgical dental diagnostic and restorative procedures performed within contemporary standards of dental patient care. When properly used and cared for, the system is safe and effective and meets advertised claims. When equipped with isolated patient water (bottle) system that is properly installed and cared for, it has been shown to reduce the number of microbes in the water dispensed.
Dental Operating Unit
This document is a 510(k) clearance letter from the FDA for a dental operating unit, not a study report or a detailed description of acceptance criteria and performance. Therefore, most of the requested information cannot be directly extracted from this document.
The document does not contain:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for test sets or data provenance.
- Number or qualifications of experts used for ground truth.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness study results.
- Standalone algorithm performance.
- Training set sample size or how its ground truth was established.
However, based on the provided text, here's what can be gathered, addressing the relevant points:
1. A table of acceptance criteria and the reported device performance
- Not available in the provided text. The document is an FDA clearance letter, which confirms substantial equivalence to a predicate device, but does not detail the specific performance metrics or acceptance criteria used in the underlying studies.
- The "Indications for use" section states: "When properly used and cared for, the system is safe and effective and meets advertised claims. When equipped with isolated patient water (bottle) system that is properly installed and cared for, it has been shown to reduce the number of microbes in the water dispensed." This is a general statement about effectiveness but not quantified performance against specific acceptance criteria.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not available in the provided text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not available in the provided text.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not available in the provided text.
5. 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 applicable and not available in the provided text. This device is a dental operating unit, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable and not available in the provided text. This device is a physical dental operating unit, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The only specific claim related to performance is the "reduction of microbes in the water dispensed" when equipped with an isolated patient water system. The "ground truth" for this claim would presumably be microbiological testing results comparing water samples with and without the system, but the specifics are not detailed.
8. The sample size for the training set
- Not applicable and not available in the provided text. This is not an AI/algorithm-based device requiring a training set.
9. How the ground truth for the training set was established
- Not applicable and not available in the provided text. This is not an AI/algorithm-based device.
§ 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.