(529 days)
For light curing polymerization of dental composites, luting materials, cements and other light cured materials.
Hi-Light and Hi-Light plus are light-emitting diode (LED) type dental curing light that is used for polymerization of light cure resin based composites. They can be used on several different dental materials that are curable by light. The devices use LED that produce a narrow spectrum of blue light in the 420~490nm range, which is useful energy range for activating the CPQ molecule, most commonly used to initiate the photo polymerization of dental monomers. The devices are designed by considering lightweight and portability. They operate on a rechargeable battery, making it easier to carry and use.
The provided text describes a 510(k) summary for a dental curing light, Hi-Light and Hi-Light Plus. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical effectiveness through extensive clinical trials for new device types. Therefore, the information typically requested for AI/ML device performance studies (like sample sizes for test sets, number of experts for ground truth, MRMC studies, etc.) is not applicable here.
Instead, the acceptance criteria and proof of meeting them for this device are based on non-clinical performance testing and substantial equivalence to predicate devices.
Here's how to extract the relevant information within the context of a 510(k) for a dental curing light:
Acceptance Criteria and Device Performance for Hi-Light / Hi-Light Plus
For a 510(k) submission of a dental curing light, the primary "acceptance criteria" revolve around demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is achieved through comparisons of technological characteristics and performance specifications derived from non-clinical testing against recognized standards.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the specifications of the predicate devices and relevant industry standards. The reported device performance is presented in comparison to these.
| Feature / Performance Parameter | Acceptance Criteria (Predicate Devices & Standards) | Reported Device Performance (Hi-Light / Hi-Light Plus) |
|---|---|---|
| Intended Use | For light curing polymerization of dental composites, luting materials, cements and other light cured materials. | For light curing polymerization of dental composites, luting materials, cements and other light cured materials. (Identical) |
| Operating Principle | LED type dental curing light for polymerization of light cure resin based composites, using blue light in the 420-490nm range. | LED type dental curing light for polymerization of light cure resin based composites, using blue light in the 420-490nm range. (Identical) |
| Light Intensity (Optical Output) | Predicate Range: Bluephase 16i (650-1600 mW/cm²), VALO Cordless (1000-3200 mW/cm²) | Hi-Light: Max 2,000 mW/cm² (±10%) across various modes (Normal: 700 mW/cm², High: 1,400 mW/cm², Turbo: 2,000 mW/cm²). Hi-Light Plus: Max 3,000 mW/cm² (±10%) across various modes (Normal: 1,000 mW/cm², High: 1,600 mW/cm², Extra: 3,000 mW/cm²). (Falls within or provides similar range/functionality to predicates) |
| Wavelength Range | Predicate: 430-490nm (Bluephase 16i), 395-480nm (VALO Cordless) | 430-490nm (Hi-Light, Hi-Light Plus) (Comparable to predicates) |
| Peak Wavelength | Predicate: 460nm (Bluephase 16i), Unknown (VALO Cordless) | 460nm (Hi-Light, Hi-Light Plus) (Comparable where specified) |
| Depth of Cure | Implied by compliance with ADA/ANSI Specification No. 48 for Visible Light Curing Units, which sets standards for adequate cure depth. Predicate data for specific depth of cure per mode not explicitly provided in table. | Hi-Light: Normal: 5.5mm, High: 5.7mm, Turbo: 4.5mm, Soft Start: 6.3mm, Pulse: 4.9mm. Hi-Light Plus: Normal: 4.6mm, High: 4.4mm, Extra: 5.0mm, Soft Start: 4.5mm, Sequential power: 4.4mm. (Results of non-clinical testing indicating functional depth of cure across modes). |
| Electrical Safety & EMC | Compliance with IEC 60601-1 (Medical Electrical Equipment - General Requirements for Safety) and IEC 60601-1-2 (Electromagnetic compatibility Requirements). | Compliance with IEC 60601-1: 2005 and IEC 60601-1-2: 2007. (Met) |
| Biocompatibility | Compliance with ISO 10993-5 (Tests for in vitro cytotoxicity) and ISO 10993-10 (Tests for irritation and skin sensitization) for patient-contacting parts (if applicable, though here it states "FDA cleared barrier sleeve" for direct patient contact). | Compliance with ISO 10993-5:2009/(R) 2014 and ISO 10993-10: 2010. (Met for components if patient contact is direct; however, the primary patient contact is through an FDA cleared barrier sleeve, mitigating direct contact with the device material) |
| Mechanical/General Performance | Compliance with ADA/ANSI Specification No. 48 and No. 48-2 for Curing Units (Visible Light Curing Units & LED Curing Lights). This standard covers aspects like light output, light homogeneity, beam profile, and other performance characteristics relevant to dental curing lights. This is the primary standard for ensuring the device performs its intended function effectively and safely. | Non-clinical tests performed in accordance with ANSI/ADA Specification No. 48: 2004 and No. 48-2: 2010. The test results met the pre-set criteria. (Met) |
Study Proving Device Meets Acceptance Criteria:
The study proving the device meets the acceptance criteria is described as "Non-Clinical Testing" and "Basis for Substantial Equivalence."
2. Sample Size for the Test Set and Data Provenance:
- Sample Size for Test Set: Not applicable in the context of typical AI/ML validation studies. For this device, the "test set" refers to physical units of the Hi-Light and Hi-Light Plus devices themselves that underwent non-clinical performance and safety testing. The document doesn't specify the number of units tested, but it would typically involve a statistically relevant sample from a production batch to ensure consistency.
- Data Provenance: The testing was non-clinical (laboratory/bench testing) performed on the physical devices. The document implies this testing was conducted by or for Dentall Corporation in the Republic of Korea, as they are the applicant. The data is thus prospective in that it was generated for this specific regulatory submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable in the AI/ML sense. The "ground truth" for a dental curing light's performance (e.g., light intensity, wavelength, depth of cure) is established by using calibrated instruments and adherence to internationally recognized standards (ANSI/ADA, IEC, ISO). The "experts" would be qualified engineers and technicians proficient in conducting these specific tests according to the standards. No human experts are used to interpret images or diagnose conditions in this context.
4. Adjudication Method for the Test Set:
- Not applicable. Performance measurements are quantitative and are not subject to human interpretation or adjudication in the way clinical diagnostic studies are. Test results are compared against a numerical specification.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Not applicable. This is not a diagnostic device that involves human readers interpreting cases.
6. Standalone (Algorithm Only) Performance:
- Not applicable. This is a medical device (hardware) with an intended physical function, not a software algorithm.
7. Type of Ground Truth Used:
- Instrumental/Standardized Measurements: The ground truth for performance characteristics (light intensity, wavelength, depth of cure, electrical safety, biocompatibility) is established through highly precise and calibrated measurement equipment and standardized test protocols as defined by ANSI/ADA, IEC, and ISO standards. For example, depth of cure is measured according to the methodology outlined in ADA/ANSI Specification No. 48.
8. Sample Size for the Training Set:
- Not applicable. There is no machine learning model involved that requires a "training set." The device is a hardware product.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no training set for an algorithm.
§ 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.