(1 days)
The Cleo bracket line is intended to operate together with other orthodontic devices to apply forces to teeth. Under the supervision of a trained dental professional or orthodontist, this may result in changes to the position of teeth.
The Cleo bracket line is indicated for orthodontic treatment of malocclusions and craniofacial abnormalities as diagnosed by a trained dental professional or orthodontist.
The Cleo bracket line of products are single-use ceramic orthodontic brackets intended to be bonded to a tooth to hold an orthodontic archwire used to apply pressure to the tooth in order to alter the position of the tooth.
The Cleo bracket line of products are made of 99.9% alumina through the process of ceramic injection molding.
Visual placement aids (VPAs) are placed in the Cleo bracket line to help provide visual contrast at the arch wire slot and intertwin areas of the bracket. The VPA is removed from the bracket before orthodontic treatment begins; VPAs do not serve a function during the orthodontic treatment. The presence of the VPA within the bracket prior to treatment will not impact the safety and performance of the bracket during the device's intended use.
The VPAs are made of polyurethane raw material through the process of injection molding.
The provided text is a 510(k) summary for the "Cleo" orthodontic bracket. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and study results for a new AI/software device.
Therefore, the information required to answer the requested questions about acceptance criteria, study design (sample size, data provenance, ground truth, expert adjudication, MRMC, standalone performance, training set details) is not present in the provided document.
This document describes a physical medical device (orthodontic brackets) and its comparison to existing similar devices based on material, design parameters, and intended use, rather than a software or AI-based device that would typically undergo the type of performance evaluation outlined in your questions.
§ 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.