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LEDEX WL-120 is a visible curing unit programmed for polymerization of dental light cured materials by dental professionals.

The LEDEX WL-120 device using highly efficient LEDs with a thermal management system, while maintaining consistent performance even in the most challenging and demanding curing needs. The light has four LED curing chips with a range of 390 nm, thus effectively curing all composites. About the light guide rod, it is made of genuine optical fiber which can optimize light conduction and minimize loss of light from source to tip. It therefore ensures the most possible intensity of light at the light guide tip. Furthermore, we design advanced efficient cooling heat sink which accompanies with over temperature protection. The thermal protection circuits prevent the light from overheating and help to keep the device in a safety mode. Automatic memorizing the last group of operation is another unique feature of this device.

The provided documentation describes the acceptance criteria and the study that proves the device, LEDEX WL-120, meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size used for the test set in terms of the number of devices or number of materials tested. It refers to specific standards for performance testing (ANSI/ADA Specification No. 48-2, No. 48, and FDA Guidance). These standards typically define the procedures and potentially the sample sizes for testing medical devices.

The data provenance is implied to be from in-vitro testing conducted by DENTMATE TECHNOLOGY CO., LTD. for regulatory submission, rather than data from human subjects or from a specific country of origin in terms of clinical data. It is a prospective generation of data for the purpose of the 510(k) submission.

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

Not applicable. This is a medical device clearance based on engineering and performance testing against recognized standards, not on expert-adjudicated clinical or imaging data. The "ground truth" is defined by the technical specifications and performance limits set by the referenced standards (ANSI/ADA, IEC, and FDA guidance documents).

4. Adjudication method for the test set

Not applicable. The tests performed are objective measurements against established technical specifications and performance requirements defined in the cited standards, not subjective assessments requiring expert adjudication.

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. The LEDEX WL-120 is a dental curing light, not an AI-powered diagnostic or assistive device for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device.

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

Not applicable. The LEDEX WL-120 is a physical medical device (dental curing light), not an algorithm or software. It is designed to be used by dental professionals (human-in-the-loop operates the device). The performance tests are for the device's physical output and effect on dental materials, not for an algorithm's standalone performance.

7. The type of ground truth used

The "ground truth" for the performance of the LEDEX WL-120 is based on established technical specifications and performance requirements outlined in recognized national and international standards. These include:

• American National Standard/American Dental Association (ANSI/ADA) Specification No. 48-2: 2010, Reaffirmed 2015, LED Curing Lights
• American National Standard/American Dental Association (ANSI/ADA) Specification No. 48: 2020, Approved 2020, Curing Lights (Powered Polymerization Activators)
• FDA Guidance for Industry and FDA Staff, Dental Curing Lights - Premarket Notification 510(k) Submissions, Clause 8. Performance Specifications
• IEC 60601-1 (Electrical safety)
• IEC 60601-1-2 (Electromagnetic compatibility)
• ISO 10650:2015 (Dentistry - Powered polymerization activators)

These standards define acceptable ranges for parameters like irradiation, spectral irradiance, and depth of cure, as well as safety criteria.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a training set. The performance evaluation is based on testing a physical device against specified criteria.

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

Not applicable, as there is no training set for this device.

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LEDEX WL-070+ is a visible curing unit programmed for polymerization of dental light cured materials by dental professionals.

Not Found

This is a 510(k) summary document for K163605, a dental curing light, not an AI/ML device. Therefore, the requested information about acceptance criteria, study details, expert involvement, and training/test sets for an AI/ML device cannot be extracted from this document. The document describes the FDA's clearance of a physical medical device (LEDEX WL070+) and confirms its substantial equivalence to a predicate device, based on its intended use as a visible curing unit for polymerization of dental light-cured materials.

The provided text does not contain any details about the acceptance criteria or a study proving that an AI/ML device meets such criteria.

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LEDEX (Family model: WL-090, WL-090+) is a visible curing unit programmed for polymerization of dental light cured materials by dental professionals.

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The provided document is a 510(k) premarket notification letter from the FDA for a dental light curing unit (LEDEX WL-090 and WL-090+). This type of document does not typically contain detailed information about acceptance criteria and the specifics of a study proving device performance in the way requested.

The letter primarily states that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has similar indications for use and technological characteristics to an existing device. The FDA's review for substantial equivalence generally relies on a comparison to predicate devices rather than requiring new, extensive performance studies with detailed acceptance criteria and ground truth establishment as would be expected for a novel AI/software medical device.

Therefore, most of the requested information cannot be extracted from this document, as it pertains to a different type of device and regulatory review process.

However, I can extract the following limited information:

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

• Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for a study. The acceptance criterion from the FDA's perspective is "substantial equivalence" to a predicate device.
• Reported Device Performance: Not detailed in a study format within this document. The device is described as a "visible curing unit programmed for polymerization of dental light cured materials." Its performance is implicitly considered sufficient because it was found substantially equivalent to existing devices that perform this function.

2. Sample size 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 performance study with a test set.

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 clinical performance study requiring ground truth establishment by experts.

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 is not an AI-assisted device.

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

• Not Applicable. This is not an AI/algorithm device.

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 is not an AI/machine learning device that requires a training set.

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

• Not Applicable.

In summary, the provided document is an FDA 510(k) clearance letter for a dental light curing unit, not a study report for an AI/software medical device. As such, the detailed information regarding acceptance criteria, study design, ground truth establishment, and expert involvement that you've requested is not present in this type of regulatory correspondence.

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This LEDEX WL-070 is a visible curing unit programmed for polymerization of dental light cured materials by dental professionals.

Not Found

The provided document is a 510(k) clearance letter from the FDA for a dental curing light, the Ledex WL-070. It confirms that the device is substantially equivalent to a legally marketed predicate device. However, this document does not contain the detailed information necessary to complete the requested table and answer the specific questions about acceptance criteria and a study design.

Here's why and what information is missing:

• Substantial Equivalence (SE) vs. Performance Studies: The FDA's 510(k) clearance process for most devices (especially Class II) primarily relies on demonstrating "substantial equivalence" to a predicate device. This often involves showing that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness. While performance data are usually submitted, the FDA letter itself generally does not detail the specific acceptance criteria, study methodologies, or the results in the comprehensive way you've requested for an AI/CADe type of device.
• Device Type: The Ledex WL-070 is an "Ultraviolet Activator For Polymerization" (a dental curing light). This is a hardware device, not an AI/CADe (Computer-Aided Detection/Diagnosis) software. The questions you've posed (e.g., MRMC studies, human readers with/without AI assistance, training/test sets, ground truth establishment for AI) are highly specific to AI/CADe systems, which are designed to assist human interpretation or to perform standalone diagnostic tasks with learned algorithms. A dental curing light hardens dental materials, and its performance is typically evaluated by criteria like light intensity, wavelength, curing depth, and temperature, not by AI-specific metrics.

Therefore, I cannot populate the table or answer the questions with the provided document. The document confirms market clearance but does not delve into the specific study details for acceptance criteria and performance as would be relevant for an AI/CADe device.

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