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

Symetri Clear, is a single-use orthodontic bracket made from polycrystalline alumina. This device is intended for the orthodontic movement of teeth. It is used temporarily and is removed after Orthodontic treatment has been completed. After following standard office protocols for tooth preparation, the brackets are bonded to the teeth with an orthodontic adhesive or cement. To aid with visual placement of the bracket to the tooth surface, the bracket has a removable, color coded, plastic axis indicator that is lifted away from the bracket following tooth placement or temporary color coded labial tie wings that are removed with a toothbrush and water. To identify tooth designation, the brackets include a temporary ink dot that is removed with a toothbrush and water after the brackets have been placed on the tooth. After the brackets are placed, an archwire is then inserted / threaded through the bracket's archwire slot and is held in place with a ligature tie. These ligatures are tightened, or ligated, around the 'wings' of the bracket and over the archwire. To aid in optimal teeth movement, the individual brackets can also be ligated to other brackets or other orthodontic devices. After the teeth have moved into their proper positions, the orthodontic / dental professional will remove the brackets with the Symetri Clear Debonding Instrument / Pliers. This step is also known as debonding.

AI/ML Overview

The provided document is a 510(k) Pre-Market Notification for the Symetri Clear orthodontic bracket. This type of submission focuses on demonstrating substantial equivalence to pre-existing, legally marketed devices, rather than comprehensive clinical performance studies typical for novel medical devices.

Therefore, the document does not contain information about acceptance criteria and the study that proves the device meets those criteria in the context of typical AI/ML device evaluations. Instead, it describes non-clinical performance data to demonstrate equivalence.

Here's an analysis of what is provided, and what is missing based on your requested information:

Key Takeaways from the document:

Device Type: The Symetri Clear is an orthodontic bracket made from polycrystalline alumina, intended for the orthodontic movement of teeth. It is a physical medical device, not a software/AI device.
Regulatory Pathway: 510(k) Pre-Market Notification, demonstrating substantial equivalence to predicate devices (3M Unitek Corporation's Clarity™ ADVANCED Ceramic Brackets (K102803) and Damon™ 4Clear (K081415)).
Performance Data: The submission relies on non-clinical performance data and biocompatibility assessments to establish substantial equivalence. No clinical performance data was performed or submitted for Symetri Clear.
No AI/ML Component: There is no indication that the Symetri Clear device itself or its use involves any Artificial Intelligence or Machine Learning component.

Addressing your specific questions based on the provided document:

A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as pass/fail numeric thresholds in the document. The general acceptance criterion implied is "perform comparably to the predicate devices" for various non-clinical tests.
- Reported Device Performance: The document states: "The testing analysis shows that Symetri Clear brackets perform comparably to the predicate devices." Specific numerical results for each test (Torque Strength, Double Tie Wing Strength, Bond Strength Shear, Bond Strength Tensile, Wire Drag, Debonding Removal Fracture, Hook Strength, Staining) are not included in this summary.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in this document for the non-clinical tests.
- Data Provenance: Not specified. It's non-clinical lab testing.
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. This is a physical device submission demonstrating mechanical and material properties. There is no "ground truth" in the diagnostic sense, nor is there a panel of experts evaluating diagnostic performance. The "ground truth" would be the standard scientific methods and measurements for the physical properties being tested.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. See point 3.
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 not an AI-assisted device. No MRMC study was conducted or is relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable/Implied: For non-clinical tests, the "ground truth" is defined by the standardized measurement methodologies (e.g., ISO 27020 for dimensions) and the results obtained from those methodologies. It's not a diagnostic "ground truth."
The sample size for the training set
- Not Applicable. There is no "training set" as this is not an AI/ML device.
How the ground truth for the training set was established
- Not Applicable. See point 8.

In summary, the provided document is a regulatory submission for a traditional, physical medical device (an orthodontic bracket) and details non-clinical performance testing to demonstrate substantial equivalence to predicate devices, not an AI/ML device with associated acceptance criteria, ground truth, or clinical study designs typically associated with your questions.

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.