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K Number
K123092
Device Name
CERAMIN BRACKETS Z
Manufacturer
TOMY, INC.
Date Cleared
2012-12-21

(80 days)

Product Code
NJM
Regulation Number
872.5470
Type
Traditional
Panel
DE
Reference & Predicate Devices
K102803,K060837
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The CERAMIC BRACKETS Z are indicated for orthodontic movement on natural teeth surfaces.

Device Description

The CERAMIC BRACKETS Z are designed to move teeth to improve their alignment.

The CERAMIC BRACKETS Z are bonded to natural teeth by dental professionals to connect with orthodontic wires to cause tooth movement to a more preferred position.

No accessories are marketed with the CERAMIC BRACKETS Z . The dental clinician is free to choose the bonding cement, supplemental ligatures and orthodontic wires for use with the brackets.

The CERAMIC BRACKETS Z are composed of a polycrystalline zirconia ceramic bracket, which includes an archwire slot and tiewings. The self-ligating CERAMIC BRACKETS Z have a metal clip so that no other ligation of the archwire is needed.

AI/ML Overview

Here's a summary of the acceptance criteria and study information for the CERAMIC BRACKETS Z, based on the provided 510(k) summary:

This device is an orthodontic bracket. The acceptance criteria and testing focus on the physical performance of the brackets, as is typical for this type of medical device. There is no information provided about studies involving human subjects, reader performance, or clinical outcomes that would typically be seen in studies for diagnostic devices or AI-powered devices.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria CategorySpecific Test PerformedReported Device Performance
Mechanical StrengthShear Bond TestsPerformed and validated
Mechanical StrengthTorque (Fracture) TestsPerformed and validated

Note: The 510(k) summary states that "Bench testing was performed to ensure that the CERAMIC BRACKETS Z performance was achieved and validated, including shear bond tests and torque (fracture) tests." However, specific numerical acceptance criteria (e.g., minimum bond strength in MPa, minimum torque resistance in Ncm) and the corresponding measured device performance values are not provided in this summary. It only indicates that the tests were performed and the performance was achieved and validated.

Study Details (Based on available information)

  1. Sample size used for the test set and the data provenance:

    • Test Set Sample Size: Not specified.
    • Data Provenance: The tests are described as "Bench testing," implying laboratory-based testing on the physical devices rather than patient data. The manufacturer is based in Japan (TOMY, Inc., Tokyo, Japan).

  2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

    • Not applicable. This device does not involve expert interpretation or ground truth derived from human assessments in the context of diagnostic or AI performance. The "ground truth" for mechanical testing would be the physical properties measured by testing equipment.

  3. Adjudication method for the test set:

    • Not applicable. As noted above, this does not involve human interpretation or adjudication.

  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:

    • No. This is a physical medical device (orthodontic bracket), not a diagnostic device or an AI-powered system designed to assist human readers. Therefore, an MRMC study is not relevant or performed for this product.

  5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

    • No. This is a physical medical device, not an algorithm or AI system.

  6. The type of ground truth used:

    • The "ground truth" in this context refers to the measured mechanical properties (shear bond strength, fracture torque) obtained through standard laboratory testing methods for orthodontic brackets. These are objective physical measurements.

  7. The sample size for the training set:

    • Not applicable. This device does not involve machine learning or an AI algorithm, so there is no "training set."

  8. How the ground truth for the training set was established:

    • Not applicable as there is no training set.

§ 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.