(196 days)
For teething human infants to chew on. To soothe gums when teething.
fluid-filled teething ring
I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a "Fluid-Filled Teething Ring." It confirms the substantial equivalence of the device to legally marketed predicate devices and outlines regulatory requirements.
However, this document does not contain any information about acceptance criteria or a study proving the device meets those criteria.
Therefore, I cannot extract the requested information (table of acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details) from the text provided. This FDA letter is a regulatory approval, not a scientific study report.
§ 872.5550 Teething ring.
(a)
Identification. A teething ring is a divice intended for use by infants for medical purposes to soothe gums during the teething process.(b)(1)
Classification. Class I if the teething ring does not contain a fluid, such as water. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.(2) Class II (special controls) if the teething ring contains a fluid, such as water. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.