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The Easy-Curing™ is a high intensity blue LED light source, used to polymerize standard, restorative materials, adhesives, and sealants which cure at a wavelength of 450 - 490 nm, off the shelf, dental curing materials in the dentist's clinic.

The Easy-Curing™ is a high intensity blue LED light source.

This document is a 510(k) clearance letter for the "Easy-Curing Pen-Style Led Curing Light" and does not contain the detailed study information typically found in a clinical trial report or a summary of safety and effectiveness (SSE) document. Therefore, I cannot provide a complete answer to your request based solely on the provided text.

Specifically, the document confirms that the device is substantially equivalent to legally marketed predicate devices, but it does not describe a new study conducted to establish performance beyond that. It primarily details regulatory information, product classification, and indications for use.

Here's what I can extract and what is missing:

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

• Acceptance Criteria: Not explicitly stated in this document as quantitative performance metrics. The implicit acceptance criterion is "substantial equivalence" to predicate devices for its intended use of polymerizing dental materials.
• Reported Device Performance: The document states the device is a "high intensity blue LED light source, used to polymerize standard, restorative materials, adhesives, and sealants which cure at a wavelength of 450 - 490 nm." No specific performance metrics (e.g., light intensity, curing depth, bond strength measurements) are provided within this letter. Such data would typically be in the 510(k) submission itself, not the clearance letter.

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

• Not provided. This document does not detail any specific test set or data provenance from a new study.

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

• Not provided. This information would pertain to a specific study, which is not described here.

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

• Not provided.

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 a curing light, not an AI-assisted diagnostic tool or an imaging device that would involve human "readers."

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

• Not applicable. This is a physical medical device (curing light), not an algorithm.

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

• Not provided. For a curing light, ground truth would likely involve laboratory measurements of curing efficacy, such as hardness, depth of cure, or bond strength, compared to a reference standard. This information is not in the provided text.

8. The sample size for the training set:

• Not applicable/Not provided. This is a physical device, not an AI model requiring a training set.

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

• Not applicable/Not provided.

In summary, the provided FDA 510(k) clearance letter confirms regulatory approval based on substantial equivalence but does not contain the detailed study results or performance data that would address your specific questions about acceptance criteria and study methodology. Such information would be found in the original 510(k) submission documentation, which is not included here.

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