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K Number
K112707
Device Name
GENERATION C AESTHETIC SELF-LIGATING BRACKET SYSTEM
Manufacturer
ORTHO TECHNOLOGY, INC
Date Cleared
2012-01-13

(116 days)

Product Code
NJM
Regulation Number
872.5470
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Generation CTM Aesthetic Self-Ligating Bracket System indication for use is to correct malocclusions of the teeth as determined by a licensed Orthodontist/Dentist. The brackets are intended to only be bonded to natural teeth. The brackets are used with orthodonic wire to control the direction of the tooth movement of the individual teeth by providing a slow and continuous force to the teeth.

Device Description

Generation CTM Aesthetic Self-Ligating Bracket System

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for an orthodontic bracket system. It is not a study report and therefore does not contain the detailed information requested regarding acceptance criteria, device performance results, sample sizes, expert qualifications, or ground truth establishment.

A 510(k) clearance letter primarily assesses substantial equivalence to a predicate device and does not typically include a detailed performance study with specific acceptance criteria and results in the manner a clinical trial report or a comprehensive validation study would.

Therefore, I cannot provide the requested information from the given document as it does not contain details about:

  1. A table of acceptance criteria and the reported device performance
  2. Sample sized used for the test set and the data provenance
  3. Number of experts used to establish the ground truth for the test set and their qualifications
  4. Adjudication method for the test set
  5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers improving with AI vs without AI assistance
  6. If a standalone (algorithm only) performance study was done
  7. The type of ground truth used
  8. The sample size for the training set
  9. How the ground truth for the training set was established

This document only confirms that the FDA reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices.

§ 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.