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The Flexi-Lume LED System is intended to polymerize dental materials, restorative composite materials, orthodontic brackets bonding and sealing materials, restorative composite materials, enneded of visible light. It is matenals that are process poympatient's oral structures. It is also intended for bleaching arocedures to apply light to a tooth after it is treated with a bleaching agent.

The Flexi-Lume LED System is classified as an Ultraviolet Activator for Polymerization (21 CFR 872.6070) because it is a device intended for the photo-polymerization of light-cured dental materials. The Flexi-Lume contains a multifunction LED that directs light via a fiber optic gooseneck to the patient's mouth. The LED light has several modes: Daylight white (color temperature 5500K), Fluorescent white (color temperature 3500K), Transdental Illumination, Bleaching Light, Non-Curing light (all visible wavelengths excluding blue wavelengths), and Curing Light. The Curing Light mode produces visible blue light in the 430-490nm waveband of the light spectrum with a power density of 1,500mW/cm2. This power density is sufficient for the product intended uses, generally the photo-polymerization of visible light cured dental materials, restorative composite materials, orthodontic brackets and orthodontic bonding and sealing materials. The different lighting modes can be selected with touch controls on the housing. The touch controls also include a dimmer which allows the selection of light intensity in all modes except Curing and Bleaching, which have pre-set intensity levels. The Flexi-Lume runs on 12VDC, powered by a certified AC/DC adapter that can be hidden inside the dental chair.

Here's a breakdown of the acceptance criteria and study information for the Flexi-Lume LED System (K140281), based on the provided text:

Acceptance Criteria and Device Performance

Note: The provided document details substantial equivalence based on meeting the same performance metrics as the predicate device.

Study Information

The provided document describes non-clinical bench testing to establish substantial equivalence, rather than clinical studies involving human subjects or algorithm-only performance.

1. Sample size used for the test set and the data provenance: Not applicable. This was non-clinical bench testing. The "test set" would refer to the physical device and its components undergoing specific measurements. The document does not specify a "sample size" in the context of a dataset, nor does it refer to data provenance (e.g., country of origin, retrospective/prospective).

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for non-clinical bench testing typically relies on standardized measurement techniques and established engineering principles, not expert human interpretation of data in the same way a diagnostic study would.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as this was non-clinical bench testing.

4. 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 dental curing light, not an AI-powered diagnostic tool, so MRMC studies involving human readers are not relevant.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the non-clinical bench testing, the "ground truth" would be established by validated measurement equipment and standardized testing procedures (e.g., using a radiometer for light intensity, calibrated depths for curing depth measurements).

7. The sample size for the training set: Not applicable. This device does not involve a "training set" in the context of machine learning.

8. How the ground truth for the training set was established: Not applicable.

Summary of Nonclinical Tests Performed:

The nonclinical bench testing for the Flexi-Lume LED System included:

• Verification of Spectral Irradiance Output "Exitance"
• Verification of Irradiance Intensity (at peak wavelength)
• Depth of Cure
• Verification of Case Temperature Rise

These tests were conducted in accordance with IEC 60601-1 and FDA Guidance Document 1591 to demonstrate substantial equivalence to the predicate device (K121093). Software validation was performed in accordance with IEC 62304.

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