(169 days)
The Clean Source One, or CS1, is indicated to be used as an in-line water treatment system to reduce microorganisms in dental unit water lines.
Clean Source I, Model CS1000
The provided document is a 510(k) clearance letter from the FDA for a dental unit water line treatment system called "Clean Source I, Model CS1000." This letter indicates that the device has been found substantially equivalent to a legally marketed predicate device.
However, a 510(k) clearance letter **does not typically contain the detailed information required to describe
- acceptance criteria,
- detailed study designs,
- sample sizes for test and training sets,
- specifics on ground truth establishment,
- expert qualifications, or
- MRMC study results**
that are typically found in a clinical study report or a 510(k) submission summary. The letter is a regulatory approval document, not a scientific study report.
Therefore,Based on the provided document alone, I cannot answer the specific questions about acceptance criteria and the study that proves the device meets them because this information is not present in the FDA clearance letter.
The letter only states that the device is "substantially equivalent" for its indicated use (reducing microorganisms in dental unit water lines). To find the kind of information requested, one would need to consult the original 510(k) submission document (K981144), which is not provided here.
§ 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.