(140 days)
Radiance is an orthodontic bracket. Orthodontic brackets are prescribed for patients with teeth that are not normally positioned in the mouth.
An orthodontic bracket is a device consisting of a base, an arch wire slot and four tie wings. The bracket bases are attached to a patient's teeth with adhesive. A metal arch wire is placed in the arch wire slot of a set of brackets (typically ten brackets on each of the upper and lower arches) and the wire is held in place in each bracket slot with an elastic o-ring placed under the tie wings and over the arch wire.
This looks like a 510(k) clearance letter for an orthodontic bracket, not a study report for an AI/ML medical device. Therefore, the requested information regarding acceptance criteria and study details for an AI-powered device cannot be extracted from this document.
The document discusses the device "Radiance" which is an orthodontic plastic bracket, and the FDA's determination of its substantial equivalence to predicate devices. It does not contain information about software algorithms, performance metrics for AI, test sets, ground truth establishment, or human reader studies.
Therefore, I cannot fulfill the request based on the provided input.
§ 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.