FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

CompleClear Plastic Orthodontic Bracket and Wire Appliance is an orthodontic appliance consisting of a polysulfone bracket with two separate components (tooth component and wire component) and an orthodontic wire pre-attached to the wire component of the bracket. The tooth and the wire components are capable of mechanically interlocking to form a detachable and reattachable bracket assembly. The tooth component of the bracket is cemented to the tooth, like regular orthodontic brackets. The wire components are pre-attached at specific positions along the orthodontic wire. The orthodontic wire is customized for each patient by creating various bends and rotations along the wire. This configuration of the customized wire, results in a specific position and orientation of the wire components of the bracket system along the customized wire. This customized orthodontic wire along with the series of pre-attached wire components constitutes the 'aligner'. When the wire components of the 'aligner' are engaged on to the corresponding tooth component cemented on the tooth, the orthodontic wire is activated like a spring. The tooth is gently moved to its desired position due to the elastic recoil of the wire.

The two component bracket assembly of the present device allows moment arms for mesiodistal rotation, labio-lingual inclination and mesio-distal angulations (tip) similar to conventional bracket-wire used in orthodontics.

The treatment uses a series of aligners, each incorporating a predefined amount to tooth movement toward the final desired end goal. The amount of tooth movement incorporated, the type of tooth movement incorporated and the final desired end goal are all determined and approved by the provider.

AI/ML Overview

This document, a 510(k) summary for the CompleClear Plastic Orthodontic Bracket and Wire Appliance (K150830), does not contain information about acceptance criteria or a study proving the device meets specific performance metrics in the format requested.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices (K110796 and K140807) based on indications for use, materials, aesthetic features, mode of use, physical properties, application, and manufacturing methods.

Here's what can be extracted from the document regarding testing, though it doesn't align with the detailed "acceptance criteria and study" structure you've requested for AI/software devices:

1. Acceptance Criteria and Reported Device Performance (as interpreted from the mechanical testing)

Acceptance Criteria (Implied)	Reported Device Performance
Force applied by deflection of wire within orthodontic range	Force applied by deflection of the wire was within the range of other orthodontic forces.
Force to break melt and remove wire from bracket > applied wire force	Force required to break the melt and remove the wire from the bracket was significantly higher than the force which could be applied by the wire.
Force to snap aligner from cemented brackets > orthodontic forces	Force necessary to snap the aligner away from the cemented brackets was also significantly higher than the orthodontic forces applied to the teeth.
Integrity of aligner during function	This ensures integrity of the aligner during function.
Aligner does not detach unintentionally	Aligner does not detach until the dentist or patient intends to remove it.
Shear bond strength statistically equivalent to predicate devices	There was no statistical difference in shear bond strength between CompleClear and Ortho Specialties' brackets.

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

The document does not specify general sample sizes for the mechanical tests. For the shear bond strength testing, it refers to "both CompleClear and Ortho Specialties' brackets" implying a comparison was made but no specific number of samples is given.
Data provenance is not mentioned (e.g., country of origin, retrospective/prospective).

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

Not applicable as this is a physical device and the testing described is mechanical, not involving human expert assessment for ground truth.

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

Not applicable. This type of testing does not involve adjudication by experts.

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. This is not an AI/software device and no MRMC study was performed or described.

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

Not applicable. This is not an AI/software device.

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

For mechanical tests, the "ground truth" would be established by the physical properties of the materials and the design of the device, measured through standard engineering and materials science testing methodologies. For shear bond strength, it was a direct measurement comparison.

8. The sample size for the training set:

Not applicable. This is not an AI/software device.

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

Not applicable. This is not an AI/software device.

In summary, this document is a 510(k) premarket notification for a physical orthodontic device. The "proof" of meeting acceptance criteria is primarily demonstrated through mechanical testing to show equivalency to legally marketed predicate devices, not through studies involving AI performance or human reader analysis as typically required for AI/ML-based medical devices.

Summary

Regulation Number and Section

§ 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.