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K Number
K080246
Device Name
COMPOSITE ALIGNER BUTTON
Manufacturer
DENTSPLY INTERNTIONAL
Date Cleared
2008-04-11

(71 days)

Product Code
NXC
Regulation Number
872.5470
Type
Traditional
Panel
DE
Reference & Predicate Devices
K981095,K072522
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The COMPOSITE ALIGNER BUTTON is an accessory that is attached to dental or orthodontic aligners to assist in minor tooth movement.

Device Description

The COMPOSITE ALIGNER BUTTON is made of plastic and is bonded to an aligner for attaching elastics and other appliances.

AI/ML Overview

The provided documentation is a 510(k) summary for the DENTSPLY COMPOSITE ALIGNER BUTTON. This submission primarily focuses on establishing substantial equivalence to predicate devices based on technological characteristics and intended use, rather than presenting a study demonstrating performance against specific acceptance criteria in the manner often seen for more complex diagnostic or image analysis AI/ML devices.

Therefore, much of the requested information (acceptance criteria, device performance, sample sizes, ground truth establishment, expert roles, MRMC studies) is not applicable or not present in this type of regulatory submission for this specific device.

Here's an breakdown based on the information available and what is not applicable:

1. A table of acceptance criteria and the reported device performance:

  • Not Applicable / Not Provided. This 510(k) relies on demonstrating that the Composite Aligner Button has similar technological characteristics (made of plastic, components used in legally marketed devices, biocompatibility) and the same intended use as legally marketed predicate devices. The "performance" in this context is the general safety and effectiveness implied by its composition and intended use, which is established through comparison to predicates rather than a specific performance metric against a defined acceptance criterion.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

  • Not Applicable / Not Provided. No "test set" in the context of performance metrics (like sensitivity, specificity, accuracy) is mentioned or required for this type of device submission. The submission is based on the characteristics of the device itself and its components, not on its performance in a clinical study with a test set of data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

  • Not Applicable / Not Provided. No ground truth establishment for a test set is discussed, as there was no performance study of this nature.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

  • Not Applicable / Not Provided. No test set or adjudication method is mentioned.

5. 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 / Not Provided. This device is an accessory for orthodontic aligners, not an AI/ML diagnostic or image analysis tool. Therefore, an MRMC study related to AI assistance is irrelevant and was not conducted.

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

  • Not Applicable / Not Provided. This device is a physical accessory and does not involve an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

  • Not Applicable / Not Provided. No ground truth is referenced as no performance study requiring a ground truth was conducted.

8. The sample size for the training set:

  • Not Applicable / Not Provided. No training set for an AI/ML algorithm is involved with this physical accessory.

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

  • Not Applicable / Not Provided. As no training set is discussed, there's no ground truth establishment for it.

Summary of available relevant information from the 510(k) submission:

  • Device Name: COMPOSITE ALIGNER BUTTON
  • Intended Use: An accessory that is attached to dental or orthodontic aligners to assist in minor tooth movement.
  • Technological Characteristics claimed to ensure safety and effectiveness:
    • Made of plastic.
    • Components have been "used in legally marketed devices and/or were found safe for dental use."
    • Appropriate biocompatibility testing has been completed.
  • Predicate Devices:
    • Align System K981095
    • Thermoform Sheet Materials and Accessories K072522
  • Basis for Acceptance: The device was found substantially equivalent to the predicate devices based on its intended use and technological characteristics, particularly the prior safe use of its components and biocompatibility data. This type of submission does not involve a clinical study with performance metrics against acceptance criteria, but rather a regulatory review of equivalence.

§ 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.