LogoFDA 510(k) Search
K Number
K160615
Device Name
ORTHODONTIC CERAMIC BRACKETS 1.1
Manufacturer
TOMY, INC
Date Cleared
2016-08-26

(176 days)

Product Code
NJM
Regulation Number
872.5470
Type
Traditional
Panel
DE
Reference & Predicate Devices
K102803,K123094
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

ORTHODONTIC CERAMIC BRACKETS 1.1 are indicated for orthodontic movement of natural teeth.

Device Description

ORTHODONTIC CERAMIC BRACKETS 1.1 are designed to move teeth to improve their alignment. ORTHODONTIC CERAMIC BRACKETS 1.1 are bonded to natural teeth by dental professionals to connect with orthodontic wires to cause tooth movement to a more preferred position.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for Orthodontic Ceramic Brackets 1.1 by Tomy Inc. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed clinical study for an AI/CADe device. As such, most of the requested information regarding acceptance criteria, study design, expert involvement, and ground truth for an AI system is not applicable or present in this document.

However, I can extract the information relevant to the performance data and equivalence claims for the physical device as described:

Acceptance Criteria and Device Performance (for physical device)

The device, Orthodontic Ceramic Brackets 1.1, claims conformance to a recognized consensus standard and reports performance based on specific mechanical tests.

Acceptance Criteria (Standard / Test)Reported Device Performance
ISO 27020 First edition 2010-12-15: Dentistry - Brackets and Tubes for use in OrthodonticsThe device conforms to this standard.
Shear Bond StrengthTested. (Specific numerical results not provided in this summary, but the implication is that it met acceptable levels for equivalence).
Torque StrengthTested. (Specific numerical results not provided in this summary, but the implication is that it met acceptable levels for equivalence).

Note: The document states that the device was tested for Shear Bond Strength and Torque Strength, and it conforms to the ISO standard. It does not provide specific numerical acceptance thresholds or the measured performance results in this summary. The primary goal of this submission is to demonstrate substantial equivalence, implying these tests would have shown comparable performance to the predicate devices.

Study Information (for this physical device, not AI/CADe)

Since this document pertains to a physical orthodontic bracket and not an AI/CADe device, most of the detailed study and AI-specific questions are not applicable.

  1. Sample size used for the test set and the data provenance: Not applicable. This document refers to bench testing of physical brackets, not a test set of data for an AI system.
  2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI system is not relevant here.
  3. Adjudication method for the test set: Not applicable.
  4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI device.
  5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI device.
  6. The type of ground truth used: Not applicable for an AI device. For this physical device, the "ground truth" or standard of comparison is the performance of the predicate devices and conformance to the ISO standard for mechanical properties.
  7. The sample size for the training set: Not applicable. This is not an AI device, so there is no training set.
  8. How the ground truth for the training set was established: Not applicable.

Summary of Relevant Information from the Document:

  • Device Type: Physical orthodontic ceramic brackets.
  • Purpose of Submission: To demonstrate substantial equivalence to previously cleared predicate devices, specifically the addition of brackets for mandibular bicuspids.
  • Performance Data Provided: Conformance to ISO 27020 and bench testing for Shear Bond Strength and Torque Strength. Specific numerical results are not detailed in this summary.
  • Biocompatibility: Not re-evaluated because the materials are the same as legally marketed predicate devices, and no material or manufacturing changes were made.
  • Clinical Testing: No animal studies or clinical testing were required for these devices.
  • Conclusion: The manufacturer believes the device is substantially equivalent to predicate devices based on design, principles of performance, and intended use, and the added mandibular bicuspid brackets do not raise new questions of safety or effectiveness.

§ 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.