(261 days)
For light curing polymerization of dental composites, luting materials, cements and other light cured materials.
The LED Curing Light is used for light curing polymerization of dental composites, luting materials, cements and other light cured materials. The device is a cordless pen style, LED light polymerization device for use by dental professionals in dental offices or dental laboratories.
The LED Curing Light protect the handpiece from gross contamination and prevent cross infection between patients by applying the single use protective sleeve. The protective sleeve (patient contact part) is made of PP material.
DB686 NANO:
The LED Curing Light DB686 NANO adopts the principle of ray radiation to solidify the light sensitive resin by shooting at it in a short time. It is composed of handpiece, cure tip, battery pack, charging base, adapter and protective sleeve. The handpiece contains the Rotary switch, Indicator light and Start key.
The LED Curing Light DB686 NANO has one mode namely: Curing light mode.
DB686 SWIFT:
The LED Curing Light DB686 SWIFT adopts the principle of ray radiation to solidify the light sensitive resin by shooting at it in a short time. It is composed of handpiece, cure tip, battery, charging base, adapter and protective sleeve. The handpiece contains the Power/Start button, Mode/ Timer button and LED Display.
The LED Curing Light DB686 SWIFT integrates three modes namely: soft up mode, high power mode and orthodontic mode.
The provided text describes a 510(k) premarket notification for a medical device called "LED Curing Light" (models DB686 NANO and DB686 SWIFT). It aims to demonstrate substantial equivalence to a predicate device (D-Lux+) and a reference device (Bluephase Style 20i) rather than presenting a study where the device meets specific acceptance criteria in a clinical or performance assessment.
Therefore, much of the requested information (acceptance criteria table, sample size, ground truth, expert qualifications, MRMC study, standalone performance) is not available in this document. The document focuses on regulatory compliance and comparison to existing devices.
Here's an attempt to extract the relevant information based on the prompt's structure:
1. A table of acceptance criteria and the reported device performance
This document does not present a table of acceptance criteria and reported device performance in the typical sense of a clinical study or a specific performance benchmark for the device itself. Instead, it demonstrates compliance with recognized medical device standards and outlines the specifications of the proposed device compared to predicate devices to establish substantial equivalence.
The "acceptance criteria" here are essentially the standards the device was tested against to confirm its safety and effectiveness, inferred from the non-clinical tests. The "reported device performance" is given in terms of features and conformity to these standards.
| Acceptance Criteria (Inferred from Standards & Equivalence) | Reported Device Performance (LED Curing Light) |
|---|---|
| Biological Safety: | |
| ISO 10993-5:2009 (Cytotoxicity) | Complies |
| ISO 10993-10:2010 (Irritation & Skin Sensitization) | Complies |
| ISO 10993-11:2017 (Systemic Toxicity) | Complies |
| Disposable Protective Sleeves (ISO 10993-5, -10, -11) | Complies |
| Electrical Safety & Performance: | |
| IEC 60601-1:2012 (Basic Safety & Essential Performance) | Complies |
| IEC 60601-1-2:2014 (EMC) | Complies |
| IEC 80601-2-60:2019 (Dental Equipment Specific) | Complies |
| IEC 62133-2:2017 (Lithium Batteries) | Complies |
| Optical/Photobiological Safety: | |
| IEC 62471:2006 (Photobiological Safety) | Complies |
| Wavelength Range: 385 - 515 nm | 385 - 515 nm (Same as predicates) |
| Light Output Intensity (DB686 NANO): 1600 - 1800 mW/cm² | 1600 - 1800 mW/cm² |
| Light Output Intensity (DB686 SWIFT): 1600 - 1800 mW/cm² | 1600 - 1800 mW/cm² (Comparable to Ref. 2000 mW/cm²) |
| Protection against blue light hazards | Achieved via Cure Tip, protective sleeves, and/or protective glasses |
| Intended Use: | |
| Polymerization of dental composites, luting materials, cements, and other light-cured materials | Matches predicate and reference devices |
| Sterility: | Non-sterile (Same as predicates) |
| Infection Control: | Use disposable Protective Sleeve and surface disinfection |
| Power Supply: | Adapter: 100-240V, 50-60Hz; Output: 5V 1.5A |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a "test set" in the context of clinical data or performance data with a specific sample size. The tests conducted are non-clinical, related to compliance with standards (e.g., biological evaluation, electrical safety). The nature of these tests does not typically involve sample sizes in the same way clinical studies do. The data provenance is implied by the testing against international standards, but specific country of origin or retrospective/prospective nature isn't stated for the non-clinical tests.
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 refers to non-clinical tests and demonstrations of compliance with standards, not a study involving expert-established ground truth for a test set of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no mention of a test set requiring adjudication in the context of this 510(k) submission.
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 device is an "LED Curing Light," which is a physical device used for polymerization, not an AI-assisted diagnostic or interpretative tool. Therefore, an MRMC study or AI-related effectiveness is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. The device is a physical LED curing light and does not involve an algorithm working in "standalone" mode.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. For the non-clinical tests, "ground truth" would be defined by the technical specifications of the device and the requirements of the standards themselves (e.g., a certain current tolerance for electrical safety, or lack of cytotoxic effect in a cell culture test). There is no "expert consensus" or "pathology" in the context of this device's non-clinical testing.
8. The sample size for the training set
Not applicable. This is a 510(k) submission for a physical medical device, not an AI/machine learning model, so there is no training set.
9. How the ground truth for the training set was established
Not applicable. As there is no training set, this question is not relevant.
§ 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.