(246 days)
For orthodontic splinting
everStick® A&O is a semi-manufactured product made of glass fibers and polymer/resin matrix. The glass fiber in everStick® A&O is unidirectional which increases the strength and stiffness of the final product perpendicular to the direction of the fibers.
This document is a 510(k) summary and FDA letter regarding the everStick® A&O device. It does not contain information about acceptance criteria or a study proving device performance in the context of typical AI/diagnostic device evaluation (e.g., sensitivity, specificity thresholds, sample sizes for test sets, expert consensus, MRMC studies).
The document is a premarket notification for a medical device (glass fiber for orthodontic splinting) that is being evaluated for substantial equivalence to a predicate device, not for performance against specific diagnostic metrics.
Therefore, I cannot extract the requested information as it is not present in the provided text. The document focuses on regulatory approval based on material composition and clinical use comparison to existing devices, not on quantitative performance metrics typically associated with AI or diagnostic studies.
§ 872.5470 Orthodontic plastic bracket.
(a)
Identification. An orthodontic plastic bracket is a plastic device intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position.(b)
Classification. Class II.