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Source of illumination for curing photo-activated dental restorative materials and adhesives.

The Le'pen is a battery-powered cordless unit designed for curing VLC materials whose initiator systems are sensitive to light in the 385-480 nm wavelength range of the visible spectrum. The unit is based on violet and blue LED (light emitting diode) technology for light generation in the desired wavelength and Li-Ion rechargeable batteries.

The Le'pen includes:

• A cordless rechargeable handpiece with a focusing light emitted from a multi LED package tip and controlled by built-in control electronics
• A base unit that plugs into main power as the handpiece stand and charger
• A cap at probe tip to block light scattering
• Disposable disinfectant barrier sleeves on the tip probe
• User manual

The provided text is a 510(k) summary for the Le'pen dental curing light. It describes the device, its intended use, and arguments for its substantial equivalence to a predicate device (Ultradent Valo Cordless K110582).

However, the document does not contain the kind of detailed information about acceptance criteria, a study proving device performance against those criteria, or clinical study specifics (such as sample size for test sets, number of experts, adjudication methods, MRMC studies, or standalone algorithm performance) that would be expected for a medical device cleared based on AI/ML or complex diagnostic capabilities.

The Le'pen is a dental curing light, a physical device used to cure photo-activated dental materials. Its clearance relies on benchtop testing demonstrating equivalent performance specifications (like radiometric power, wavelength range, depth of cure, thermal generation) and safety (electrical safety, EMC, software validation) compared to a predicate device, rather than on a study with human readers or AI-driven performance metrics.

Therefore, many of the requested items (e.g., related to AI/ML performance, ground truth establishment for test/training sets, expert adjudication, MRMC studies, effect size of human reader improvement) are not applicable to the information provided in this 510(k) summary.

Here's how to interpret the available information relative to your request:

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

The document doesn't explicitly state "acceptance criteria" in a tabular format as you might see for an AI-based diagnostic. Instead, it describes various non-clinical tests conducted and confirms that the Le'pen's performance is either "similar to or greater" than the predicate device or meets relevant standards.

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

• Sample Size: Not explicitly stated as "sample size" in the context of a clinical study or data set. The document refers to "testing" on the device itself, materials, or simulated scenarios. For example, "several dental composite resins and shades" were used for Depth of Cure testing, but the exact number isn't quantified.
• Data Provenance: The tests are benchtop, non-clinical tests performed on the physical device and related materials. No specific country of origin for test data is mentioned; it's likely from the manufacturer's testing facilities or contract labs. The tests are prospective in nature as they evaluate the specific Le'pen device.

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

This is not applicable. The ground truth for this device's performance is established by objective physical measurements and compliance with engineering standards (e.g., ISO 4049:2009 for depth of cure, IEC 60601-1 for electrical safety), not by expert consensus on medical images or diagnoses.

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

This is not applicable. No human adjudication or consensus process is mentioned for these non-clinical, objective benchtop tests.

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:

This is not applicable. No MRMC study was done as this is a dental curing light, not an AI-assisted diagnostic tool requiring human reader studies.

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

This is not applicable. There is no algorithm performance being evaluated in this context.

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

The "ground truth" for this device's performance is based on objective physical measurements (e.g., light output readings, temperature measurements, material cure depth, electrical parameters) and adherence to specified industry standards (e.g., ISO 4049:2009, IEC 60601-1).

8. The sample size for the training set:

This is not applicable. There is no "training set" in the context of an AI/ML model for this device. The device's design is based on established engineering principles for dental curing lights.

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

This is not applicable. As there is no training set for an AI/ML model, there is no ground truth established for one. The device's functionality is proven through direct physical testing against established performance metrics and industry standards. The "existing literature on LED-based dental curing lights" also contributes to the understanding of safety and efficacy.

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Source of illumination for curing photo-activated dental restorative materials and adhesives.

The Valiant Curing Light is a visible light activator for polymerization of dental materials and adhesives, such as dental resins and composites. The Valiant Curing Light is composed of a cordless handpiece, a charging base, disposable barrier sleeves, a light attenuating shield, and an instruction for use. The cordless handpiece is made of medical grade aluminum, electronic elements, glass lenses, and medical grade plastic elements. A plastic rotation switch provides an interface to switch between various modes of the cordless handpiece. Once a mode is selected, an ON/OFF button activates and executes the selected mode. The unit is battery operated and contains a removable and rechargeable Li ion battery. The charging base allows for placement and inductive charging of the handpiece when not in use. The light attenuating shield absorbs emitted light from the cordless handpiece to minimize ocular radiation to the patient and user. The Valiant Curing Light is provided non-sterile. Disposable barrier sleeves (510(k) number K132953, TIDI Shield, Model 21102, by TIDI Products) assist in mitigating patient contamination; additionally, the handpiece, charging base and light attenuating shield can withstand common surface disinfectants. Also included in the Valiant Curing Light is an instructions for use. The instructions for use details the function and four independently operable settings of the device: 1) standard curing mode, 2) ramp curing mode, 3) boost curing mode, and 4) white light mode (visualizing of dental anatomy). The white light mode can be used for intraoral illumination to aid in the visualization of dental anatomy (i.e. equivalent to a class I dental operating light, CFR 872.4630). The curing light modes 1-3 provide broad spectrum blue light (400 - 500mm, with peaks at 410nm and 475nm) to cure a variety of dental restorative materials and adhesives utilizing the most common photoinitiators (CQ and PPD). The white light mode 4 provides an aid for illuminating dental anatomy.

The document describes the Valiant Curing Light, a dental device for curing photo-activated dental restorative materials and adhesives. The submission aims to demonstrate substantial equivalence to a predicate device, the Valo Cordless (K110582).

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets these criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" for performance in a table format with pass/fail thresholds. Instead, it demonstrates performance by comparing the Valiant Curing Light to its predicate device, the Valo Cordless, and asserting "statistically similar" or "equivalent" performance in various non-clinical tests.

However, based on the non-clinical performance testing sections, we can infer the implied acceptance criteria:

Study Details

The document relies solely on non-clinical (benchtop) performance testing to demonstrate substantial equivalence. No clinical studies were deemed necessary.

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

• Sample Size: Not explicitly stated for each test (e.g., number of composite pucks, number of light measurements). The descriptions refer to "testing concluded," "measurements obtained," or "comparison testing" without specifying the number of samples or repetitions beyond general terms.
• Data Provenance: The studies were non-clinical, likely conducted in a laboratory setting by Inter-Med / Vista Dental Products. There is no mention of country of origin of the data as it's not patient data, nor is it retrospective or prospective in the clinical sense.

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

• This question is not applicable as the studies were non-clinical benchtop tests comparing physical properties and performance against a predicate device and engineering design specifications. The ground truth would be established by scientific measurement and engineering validation, not expert consensus in a clinical context.

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

• This question is not applicable as there were no human readers or expert adjudications involved in establishing ground truth for these non-clinical tests.

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:

• This question is not applicable. This is a dental curing light, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted.

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

• This question is not applicable. This device is a physical tool (a curing light), not an algorithm. Therefore, "standalone" algorithm performance is not relevant.

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

• The "ground truth" for the non-clinical tests was established through objective physical measurements and engineering validation, comparing the device's performance against its own design specifications and against the measured performance of a legally marketed predicate device (Valo Cordless). For example, microhardness measurements would be taken using standardized laboratory techniques.

8. The sample size for the training set:

• This question is not applicable. The Valiant Curing Light is a physical device, not an AI algorithm that requires a training set.

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

• This question is not applicable as there is no training set for this device.

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