(76 days)
Glenroe glow in dark elastomeric ties are used to hold the archwire in orthodontic brackets during orthodontic treatment. They are normally used for a period of 4 to 6 weeks when they are replaced with new ties.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA to Mr. John Bozman regarding "Glenroe Glow In Dark Elastomeric Ligatures". This document is a regulatory clearance letter and does not contain any information about acceptance criteria or a study proving device performance.
Therefore, I cannot answer the questions regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment. This information is typically found in the scientific documentation or clinical evaluations submitted as part of the 510(k) application, not in the clearance letter itself.
§ 872.5410 Orthodontic appliance and accessories.
(a)
Identification. An orthodontic appliance and accessories is a device intended for use in orthodontic treatment. The device is affixed to a tooth so that pressure can be exerted on the teeth. This device includes the preformed orthodontic band, orthodontic band material, orthodontic elastic band, orthodontic metal bracket, orthodontic wire clamp, preformed orthodontic space maintainer, orthodontic expansion screw retainer, orthodontic spring, orthodontic tube, and orthodontic wire.(b)
Classification. Class I (general controls). 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.