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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

AI/ML Overview

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.

Test Performed	Acceptance Criterion (Implicit)	Reported Device Performance
Radiometric Power Testing	Similar to or greater radiometric power compared to the predicate device, Valo Cordless, supporting similar functionality.	"Testing concluded that the Le'pen provided similar to or greater radiometric power compared to the predicate device, Valo Cordless. These results, in conjunction with 'Depth of Cure' testing, supports a designation of substantial equivalence as similar functionality is provided by the Le'pen and Valo Cordless."
Spectral Irradiance Testing	Spectrum emitted matches intended specifications and is nearly identical to the predicate device for curing dental materials.	"Testing verified the spectrum emitted from the Le'pen matches the intended specifications. Comparing the spectrum results between the Le'pen and Valo Cordless supports a substantial equivalent designation as both curing lights emit nearly identical wavelength spectrums for curing dental materials."
LED Lifetime	Device longevity over a three-year period.	"Testing verified device longevity through simulating LED use over a three year period. This test supports product efficacy and longevity."
Depth of Cure	Satisfactory depth of cure for various dental composite resins and shades, in line with ISO 4049:2009.	"Testing was performed in-line with the ISO 4049:2009 standard... Results confirm that satisfactory depth of cure was achieved for several dental composite resins and shades. Results support device efficacy as well as substantial equivalence as compliance with the ISO 4049:2009 standard was observed." Also, for "soft start mode" differences: "...confirmed that the Le'pen provides satisfactory depth of cure results..."
Thermal Generation	Device does not reach unsafe temperatures during typical and worst-case use.	"Testing verified that the device does not reach unsafe temperatures during typical use and simulated worst-case scenarios. Results support device safety as well as substantial equivalence as the predicate device exhibits thermal safety during routine use."
Software Validation	Device software functions properly.	"Testing confirmed the device's software is functioning properly. This test supports product efficacy and safety."
Electrical Safety and EMC	Compliance with IEC 60601-1 and IEC 60601-1-2 standards.	"Testing confirmed that the device is safety [sic] and in compliance with relevant electrical safety and electromagnetic compatibility standards (IEC 60601-1 and IEC 60601-1-2)."

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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