(35 days)
The Skylight LED Curing Light is intended to polymerize resinous dental materials, restorative composite materials, and orthodontic brackets, bonding, and sealing materials that are photo-polymerized in the 440-490 nm waveband of visible light.
Skylight by DMETEC Co., Ltd is classified as an Ultraviolet Activator for polymerization(21 C.F.R. 872.6070) because it is a device intended for the photo-polymerization light cured dental materials.
The Skylight is a universal photo-polymerization light curing source working in cordless conditions and producing visible blue light in the 440 to 490 nm waveband of spectrum with a power density comprised 1,000W/cif, 13-11mm light quide.
These power densities are sufficient for photo-polymerization in the 440-490nm waveband of visible light cured (VLC) dental materials of restorative composite, orthodontic brackets, orthodontic bonding and sealing.
The exposure time can be set by one second to 99 seconds with 3 modes of operation: Standard, Pulse, and Soft Start. It has also memory storage functions for 5 exposure programs set by the practitioner.
The provided텍스트 describes a 510(k) summary for the "Skylight LED Curing Light." It includes information about the device, its intended use, and a comparison to a predicate device, but it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.
The document explicitly states:
- "No clinical testing was conducted" This means there are no studies regarding human performance, MRMC, or standalone performance against a ground truth.
Therefore, I cannot provide the requested table or detailed information on the acceptance criteria and study as that information is not present in the provided text.
Based on the available text, here's what can be inferred riguardo testing, though it doesn't directly address acceptance criteria or performance against a ground truth in the way typically associated with AI/diagnostic device studies:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated in terms of measurable performance targets (e.g., accuracy, sensitivity, specificity). The closest concept to "acceptance" is the determination of substantial equivalence based on non-clinical testing and comparison to a predicate device.
- Reported Device Performance:
- Power Density: Comprised of 1,000 W/cm² with a 13-11mm light guide.
- Waveband: 440 to 490 nm.
- Exposure Time: Can be set from one second to 99 seconds.
- Operating Modes: Standard, Pulse, and Soft Start (3 modes).
- Memory Storage: For 5 exposure programs.
- Performance Claim: "These power densities are sufficient for photo-polymerization in the 440-490nm waveband of visible light cured (VLC) dental materials of restorative composite, orthodontic brackets, orthodontic bonding and sealing." This is a functional claim, not a measurement of diagnostic accuracy.
2. Sample size used for the test set and the data provenance:
- Not applicable. No "test set" in the context of an AI/diagnostic study was used. The testing described is non-clinical, focusing on electrical safety and electromagnetic compatibility standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No ground truth was established by experts for a test set in the context of an AI/diagnostic study.
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:
- No. The document explicitly states: "No clinical testing was conducted."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. The device is a physical light-curing unit, not an algorithm.
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 device is not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable. This device is not an AI/ML algorithm.
Summary of Study (Based on Provided Text):
The study performed was non-clinical testing to demonstrate safety and effectiveness, and to establish substantial equivalence to a predicate device (Mini L.E.D by SATELEC).
- Tests Conducted: In accordance with several EN (European Norm) standards related to electrical safety (EN 60601-1), electromagnetic compatibility (EN 60601-1-2, EN 61000-3-2, EN 61000-3-3, EN 55011).
- Purpose: To show that the device meets the requirements of these standards and does not pose safety hazards, thus supporting its safety and effectiveness in the intended environment.
- Conclusion: The tests "demonstrated safety and effectiveness of the Skylight LED curing light in the intended environment of use" and "None of the testing demonstrated any design characteristics that violated the requirements of the standards or resulted in any safety hazards."
This type of submission focuses on validating the device against established engineering and safety standards, rather than proving diagnostic performance against a medical ground truth or evaluating human performance with the 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.