(12 days)
The Cybird 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 430-490 nm waveband of visible light.
Cybird by DXM 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 Cybird is a universal photo-polymerization light curing source working in cordless conditions and producing visible blue light in the 440 to 490nm waveband of spectrum with a power density comprised 1,000W/cm², 11-8mm light-guide).These power densities are sufficient for the product intended uses ,namely, Photopolymerization in the 440-490 nm waveband of visible light cured (VLC) dental materials , Photo – polymerization in the 440-490nm waveband of visible light cured(VLC) restorative composite materials, and Photo-polymerization in the 440-490 nm waveband of visible light cured (VLC) orthodontic brackets and orthodontic bonding and sealing materials. Exposure times can be set for 5,10,15, or 20 seconds.
The DXM Co., Ltd. Cybird LED Curing Light is a device intended for the photo-polymerization of light-cured dental materials. The submission states that no clinical testing was conducted to establish its safety and effectiveness. Instead, the device's substantial equivalence to a predicate device, the Satelec Mini L.E.D (K032465), was demonstrated through non-clinical testing.
Therefore, the following information cannot be extracted from the provided text: A table of acceptance criteria and the reported device performance, sample size used for the test set and data provenance, number of experts for ground truth and qualifications, adjudication method, MRMC comparative effectiveness study results, standalone performance, type of ground truth used, sample size for training set, and how ground truth for the training set was established.
However, based on the provided text, the following details regarding the acceptance criteria and the study that "proves" the device meets them can be summarized:
Non-Clinical Acceptance Criteria and Reported Performance (via equivalence to a predicate device):
The acceptance criteria for the Cybird LED Curing Light were not explicitly stated as quantitative thresholds for performance metrics. Instead, the device's acceptability was based on demonstrating substantial equivalence to a legally marketed predicate device (Satelec Mini L.E.D, K032465) through non-clinical testing. This implies that the device's performance, as measured by these non-clinical tests, should be comparable to or within acceptable limits relative to the predicate device and established safety standards.
| Acceptance Criteria Category | Reported Device Performance (via Non-Clinical Testing) |
|---|---|
| Intended Use | Demonstrated substantial similarity to the predicate device in its intended use, which is the photo-polymerization of resinous dental materials, restorative composite materials, and orthodontic brackets, bonding, and sealing materials that are photo-polymerized in the 430-490 nm waveband of visible light. |
| Operational Characteristics | Produces visible blue light in the 440 to 490nm waveband of spectrum with a power density comprised of 1,000W/cm² (11-8mm light-guide). Exposure times can be set for 5, 10, 15, or 20 seconds. These power densities are sufficient for the intended uses. |
| Safety - Electrical Safety | Conforms to EN 60601-1: 1990 +A,+B. No design characteristics violated the requirements of this standard or resulted in safety hazards. |
| Safety - Electromagnetic Compatibility (EMC) | Conforms to EN 60601-1-2: 2001, EN 61000-3-2:2000, EN61000-3-3: 1998/A1:2001, and EN 55011: 1998/A1:1999, Class B. No design characteristics violated the requirements of these standards or resulted in safety hazards. |
| Function | Demonstrated substantial similarity to the predicate device without any design characteristics violating standard requirements or resulting in safety hazards. |
Study Information (Non-Clinical Equivalence Study):
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Sample size used for the test set and the data provenance: Not applicable in the traditional sense of a clinical trial. The "test set" consisted of the Cybird LED Curing Light itself, undergoing various engineering and electrical safety tests. The "data provenance" is from these specific non-clinical tests performed on the device by DXM Co., Ltd. There is no mention of country of origin for the data or whether it was retrospective or prospective in the context of human subjects.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in this context, was established by compliance with international and national standards for electrical safety and electromagnetic compatibility (e.g., EN 60601-1, EN 61000 series, EN 55011). These standards themselves are established by expert consensus in their respective fields, but no specific number or qualification of experts for this particular device's testing is mentioned beyond the presumption that the company performing the tests had qualified personnel.
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Adjudication method: Not applicable. The process was one of compliance testing against defined standards. Either the device met the standard (passed) or it did not (failed). There was no independent adjudication of test outcomes by multiple parties mentioned.
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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 device is an LED curing light, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was performed.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a standalone hardware product for polymerization, not an algorithm.
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The type of ground truth used: The ground truth for proving the device's safety and effectiveness was based on compliance with established international and national standards for electrical safety (EN 60601-1), electromagnetic compatibility (EN 60601-1-2, EN 61000 series, EN 55011), and demonstration of functional equivalence (power output, wavelength) to the predicate device for its intended use.
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The sample size for the training set: Not applicable. There was no machine learning model or algorithm to train.
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How the ground truth for the training set was established: Not applicable, as there was no training set.
§ 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.