(255 days)
OrthoAnalysis software is designed for use as a medical device providing tools for orthodontic model design and export, inspection, analysis and treatment simulation.
The use of the OrthoAnalysis software requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well as to have received a dedicated training in the use of the software.
Not Found
This FDA 510(k) clearance letter for "OrthoAnalysis Software" (K183695) primarily establishes substantial equivalence to a predicate device and outlines the general regulatory requirements. It does not contain information regarding specific acceptance criteria, a study proving device performance, sample sizes for test sets, expert qualifications, or details about training sets.
Therefore, I cannot provide a detailed answer to your request based on the provided input. This document is a regulatory clearance, not a technical performance report or a clinical study summary.
In summary, the provided document does not contain the information needed to answer your questions regarding acceptance criteria and study details.
§ 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.