(144 days)
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
| Descriptive Information | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| FDA-Recognized Standards: Electrical Safety | ||
| (IEC 60601-1:2005 + A1:2012, ISO 10650:2015) | Pass test and got Verification of Compliance | Test passed, Verification of Compliance obtained. |
| FDA-Recognized Standards: Electromagnetic Compatibility | ||
| (IEC 60601-1-2: 2014, ISO 10650:2015) | Pass test and got Verification of Compliance | Test passed, Verification of Compliance obtained. |
| Irradiation (Optical power testing) | Conformed to requirements of ANSI/ADA Spec. 48-2, 48, and FDA Guidance | Tests conformed to requirements of standards. |
| Spectral irradiance plot (Wavelength spectrum testing) | Conformed to requirements of ANSI/ADA Spec. 48-2, 48, and FDA Guidance | Tests conformed to requirements of standards. |
| Depth of cure (Composite hardness testing) | Conformed to requirements of ANSI/ADA Spec. 48-2, 48, and FDA Guidance | Tests conformed to requirements of standards. |
| Safety and Performance (per IEC 60601-1, ANSI/ADA Spec. No. 42, 42-2, and FDA Guidance) | No problems raised in safety and performance | Differences in operational modes did not raise any safety or performance problems. |
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.
§ 872.6070 Ultraviolet activator for polymerization.
(a)
Identification. An ultraviolet activator for polymerization is a device that produces ultraviolet radiation intended to polymerize (set) resinous dental pit and fissure sealants or restorative materials by transmission of light through a rod.(b)
Classification. Class II.