Search Results

Enlight - 2 is a light-cured, two component, orthodontic bonding adhesive intended for attachment of orthodontic appliances to teeth.

The device is a visible light-cured, two component, orthodontic bonding adhesive. It is specifically designed to be used for the attachment of orthodontic appliances to teeth.

The provided text is a 510(k) Summary of Safety and Effectiveness for a medical device called "Enlight-2," an orthodontic bracket adhesive and sealant. This document focuses on demonstrating substantial equivalence to a predicate device for market clearance, rather than presenting a detailed study with acceptance criteria and device performance results as typically found in clinical trials or performance evaluations for AI/software-as-a-medical-device.

Therefore, most of the requested information regarding acceptance criteria, study design, expert involvement, and ground truth cannot be extracted from this document, as it is not a study report in that context. The clearance is based on the device being substantially equivalent to another legally marketed device, "Enlight," implying its formulation and intended use are similar enough not to raise new questions of safety and effectiveness.

Here's the available information based on your request categories:

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

• This document does not specify quantitative acceptance criteria or provide a table of reported device performance metrics. Its clearance is based on substantial equivalence to a predicate device, meaning its functional characteristics are considered similar enough to not warrant new, extensive performance testing data in the context of this 510(k) submission.

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

• Not applicable. This document does not describe a clinical or performance study with a test set. This is a regulatory submission for substantial equivalence.

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. This document does not describe a study involving human experts establishing ground truth for a test set.

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

• Not applicable.

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 device is an orthodontic adhesive, not an AI-powered diagnostic or assistive tool for human readers.

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

• Not applicable. This device is a physical product (adhesive), not an algorithm.

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

• Not applicable.

8. The sample size for the training set

• Not applicable. This document refers to the formulation of an adhesive, not a machine learning model.

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

• Not applicable.

Summary from the document:

This 510(k) submission states that "Enlight-2 is substantially equivalent to several other legally marketed devices in the United States. The modified formulation of Enlight functions in a manner similar to and is intended for the same use as the original Enlight formula currently manufactured by Ormco Corporation."

The "acceptance criterion" in this context is regulatory: demonstrating substantial equivalence to a predicate device (Ormco Corporation's "Enlight") that was already legally marketed in the US. The device performance is implicitly considered equivalent to the predicate based on its similar formulation and intended use. The FDA's letter (K984217) confirms this substantial equivalence determination.

Ask a specific question about this device