(164 days)
For light curing polymerization of dental composites, luting materials, cements and other light cured materials.
LED Curing Light is used to restore teeth on dental patient. The device can only be used by the dentist who is qualified and well trained. This product is used on dental patient in the place of hospital or professional medical site.
LED Curing Light adopts the principle of ray radiation to solidify the light sensitive resin by shooting at it in a short time. It is composed of high-power LED, main unit, curing light shield, charger and charge station. The main unit contains the ON/OFF button, display screen, mode button and time button.
LED Curing Light provides TURBO mode and NORMAL mode with different preset exposure time. The high-power LED can produce visible blue light in the 430nm to 490nm waveband of spectrum with a power density of 1000m W/cm² to 1800m W/cm². Using different modes gives dental professionals the flexibility to polymerize virtually almost all types of composites, boding agents and sealants available in the market.
The enclosure of main unit was composed of ABS material and Aluminum, and the light quide base (patient contact part) was made from ABS material.
Here's an analysis of the provided text regarding the acceptance criteria and study for the LED Curing Light (Model: VK-018), presented in the requested format.
It's important to note that this document is a 510(k) summary, which aims to demonstrate substantial equivalence to a predicate device, not necessarily to independently prove the device meets specific clinical acceptance criteria from a standalone study. The performance testing here focuses on technical and safety specifications against recognized standards, rather than direct clinical outcomes.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria & Standard | Reported Device Performance |
|---|---|
| Performance Testing: | |
| ANSI ADA 48: 2004 Visible light curing unit (FDA recognition number 4-139) | Light output performance evaluated. (Specific values within ANSI ADA 48 are not explicitly stated, but compliance is implied.) |
| IEC 80601-2-60 Medical Electrical Equipment - Part 2-60: Particular Requirements For The Basic Safety And Essential Performance Of Dental Equipment, Edition 1.0 2012-02 (FDA recognition number 4-229) | Evaluated for basic safety and essential performance. (Specific values within IEC 80601-2-60 are not explicitly stated, but compliance is implied.) |
| Electrical Safety & EMC: | |
| ANSI/AAMI 60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety, 2005+A1:2012 (FDA recognition number 19-4) | Found to comply. |
| IEC 60601-1-2, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests, 2014 (FDA recognition number 19-8) | Found to comply. |
| Biocompatibility Testing: | |
| ISO 10993-5:2009, biological evaluation of medical devices -- part 5: tests for in vitro cytotoxicity (FDA recognition number 2-245) | Evaluated. ABS plastic (patient contact material) found to comply. |
| ISO 10993-10 Third Edition 2010-08-01, biological evaluation of medical devices - part 10: tests for irritation and skin sensitization (FDA recognition number 2-174) | Evaluated. ABS plastic (patient contact material) found to comply. |
| Software Verification & Validation Testing: | |
| FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." (Software level of concern: "moderate") | Software verification and validation testing conducted, and documentation provided as recommended. (Compliance implied.) |
| Technical Specifications (Comparison to Predicate): | |
| Light intensity (implied range of predicate: 800-2700mW/cm²) | Subject device: 1000mW/cm²-1800mW/cm² ±10%. Light intensity range is within the effective power range of the predicate device and verified via tests. |
| Light wavelength (predicate: 430~490nm range) | Subject device: 430nm-490nm. |
| Peak wavelength (predicate: 460nm) | Subject device: 455nm. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of clinical trials or artificial intelligence evaluation with human data. The testing described is primarily bench testing and compliance testing against recognized standards for the device itself. Therefore, specific sample sizes for human subjects or patient data are not applicable here.
- Data Provenance: N/A (bench testing of the device hardware and software).
- Retrospective or Prospective: N/A (bench testing).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This submission focuses on technical and safety compliance based on recognized standards and bench testing, not on comparison to expert-established ground truth from clinical images or data.
4. Adjudication Method for the Test Set
Not applicable. There is no mention of a human-adjudicated test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document explicitly states: "Clinical data were not required in this submission to support a finding of substantial equivalence." (Page 6). Therefore, an MRMC study related to human reader performance with or without AI assistance was not conducted or reported.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This device is a hardware product (LED Curing Light), not a software algorithm that performs diagnostic or assistive functions. Therefore, a standalone algorithm performance study is not relevant.
7. Type of Ground Truth Used
The "ground truth" for this device's evaluation is defined by the recognized international and national standards (e.g., ANSI ADA 48, IEC 60601 series, ISO 10993 series) and the technical specifications of the predicate device. The device's performance against these standards and specifications serves as its ground truth.
8. Sample Size for the Training Set
Not applicable. As this is a hardware medical device and not an AI/Machine Learning algorithm, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set was used.
§ 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.