(34 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 400-480 nm waveband of visible light.
Cybird is a LED curing light intended for rapid polymerization of light-cured materials by dental professionals. This product effectively reduces polymerization time on various lightcured materials and provides excellent treatment results every time. Cybird's body is made from industrial-grade aluminum which ensures its durability and excellent heat dissipation. The Cybird features multiple curing modes for maximum functionality.
The Cybird curing light produces visible blue light in the 405 nm (Gold) & 465 nm (Gold / XD) peak waveband of spectrum with a power density of 1,500mW/cm² (High Power Mode), 2,500 mW/cm2 (Ortho Mode, Gold), 2,700mW/cm2 (Ortho Mode, XD). These power densities are sufficient for the product intended uses.
405 nm (Gold) & 465 nm (Gold / XD) peak waveband of visible light cured (VLC) orthodontic brackets and orthodontic bonding and sealing materials.
Exposure times can be set for 1.5, 2, 2,5, 3 seconds for XD in Ortho Mode; 2, 3, 4 seconds for Gold in Ortho Mode; and 5,10,15, or 20 seconds in High Power Mode.
The provided text describes the 510(k) premarket notification for the "Cybird LED Curing Light" and its substantial equivalence to a predicate device. However, it does not explicitly detail acceptance criteria and a study proving the device meets those criteria in the way a clinical trial or algorithm performance study would.
Instead, the document focuses on demonstrating substantial equivalence to a legally marketed predicate device through non-clinical performance testing and compliance with various standards. The "acceptance criteria" here are implied to be the standards and measurements taken to show the device performs similarly or equivalently to the predicate and adheres to regulatory requirements.
Here's an attempt to structure the information based on your request, acknowledging the limitations of the provided text:
Acceptance Criteria and Device Performance
The "acceptance criteria" for this device are primarily demonstrated through non-clinical performance tests and compliance with established standards, aiming to show substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Standard | Acceptance Goal (Implied) | Reported Device Performance (Cybird LED Curing Light) |
|---|---|---|---|
| Curing Performance | Curing hardness | Sufficient polymerization for intended use | Performed; results not explicitly quantified as pass/fail against specific target, but implies successful curing. |
| Curing Performance | Depth of cure (per ADA Specification No. 48) | Sufficient depth of cure for intended use (e.g., 2.5mm of predicate) | Plasma mode (2 sec): 2.035mm - 2.380mm (for various materials); High Power mode (10 sec): 2.370mm - 3.795mm (for various materials). |
| Light Intensity | Maximum light intensity measurements at 2mm | Within acceptable range for intended use; comparable to predicate | 1,500mW/cm² (High Power Mode), 2,500 mW/cm2 (Ortho Mode, Gold), 2,700mW/cm2 (Ortho Mode, XD). |
| Light Spectrum | Spectral irradiation plots of all power modes | Appropriate waveband for polymerization (e.g., 400-480 nm) | Dual peak: 405nm, 465nm (GOLD); Single peak: 465nm (XD) - within 400-480 nm range. |
| Biocompatibility | In vitro cytotoxicity (AAMI / ANSI / ISO 10993-5) | No cytotoxicity | Conformity with AAMI / ANSI / ISO 10993-5:2009(R) 2014. |
| Biocompatibility | Irritation and skin sensitization (AAMI / ANSI / ISO 10993-10) | No irritation or sensitization | Conformity with AAMI / ANSI / ISO 10993-10:2010. |
| Electrical Safety | Essential performance testing (AAMI ANSI ES 60601-1) | Compliance with safety standards | Conducted in accordance with AAMI ANSI ES 60601-1:2005/(R) 2012 and A1:2012. |
| EMC Testing | Electromagnetic Compatibility (IEC 60601-1-2) | Compliance with EMC standards | Conducted in accordance with IEC 60601-1-2 Ed.3: 2007-03. |
| Software | Verification and Validation (IEC 62304) | Compliance with software lifecycle processes | Conducted as recommended in IEC62304:2006 and FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." |
| Substantial Equivalence | Comparison to predicate device | No new questions of safety or effectiveness compared to predicate | All differences (LED light source, light guard diameter, power mode, exposure time) found not to raise new questions of safety and effectiveness. |
2. Sample Size and Data Provenance
- Test Set Sample Size: The document does not specify a "test set" in the context of discrete data points for a predictive model. The testing involved various materials (e.g., Handae Chemical, Hanfil; Spident Escom 100; Dentkist Charmfil Plus; Mediclus Anycom) for depth of cure and hardness. The number of samples for each material or measurement is not provided.
- Data Provenance: The tests are non-clinical (laboratory-based performance tests) and were conducted by DXM Co., Ltd. (Republic of Korea). The data is prospective in the sense that it was generated specifically for this 510(k) submission.
3. Number of Experts and Qualifications for Ground Truth
- This information is not applicable as the document describes non-clinical performance testing of a physical device, not an AI/ML algorithm requiring expert-established ground truth for image interpretation or diagnosis. The "ground truth" for these tests would be the physical measurements and observations made by trained technicians and engineers in a laboratory setting.
4. Adjudication Method for the Test Set
- This information is not applicable for the reasons stated above. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in clinical data reviewed by multiple experts, not for physical device performance measurements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This type of study is relevant for evaluating the impact of AI on human reader performance for tasks like diagnostic interpretations. The "Cybird LED Curing Light" is a physical dental device, not a diagnostic AI tool.
6. Standalone (Algorithm Only) Performance Study
- No, a standalone (algorithm only) performance study was not done. This is also not applicable as the device is not an algorithm but a medical device.
7. Type of Ground Truth Used
- The "ground truth" for the tests described is based on physical measurements and adherence to recognized standards. For example, Depth of Cure was measured per ADA Specification No. 48, biocompatibility per ISO 10993 standards, and electrical safety per IEC 60601 standards. These are objective, empirically verifiable metrics, not expert consensus or pathology in a clinical sense.
8. Sample Size for the Training Set
- This information is not applicable. There is no "training set" as this is not an AI/ML device.
9. How Ground Truth for the Training Set Was Established
- This information is not applicable for the reasons stated above.
§ 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.