(148 days)
Source of illumination for curing photo-activated dental restorative materials and adhesives.
The Valiant Curing Light is a visible light activator for polymerization of dental materials and adhesives, such as dental resins and composites. The Valiant Curing Light is composed of a cordless handpiece, a charging base, disposable barrier sleeves, a light attenuating shield, and an instruction for use. The cordless handpiece is made of medical grade aluminum, electronic elements, glass lenses, and medical grade plastic elements. A plastic rotation switch provides an interface to switch between various modes of the cordless handpiece. Once a mode is selected, an ON/OFF button activates and executes the selected mode. The unit is battery operated and contains a removable and rechargeable Li ion battery. The charging base allows for placement and inductive charging of the handpiece when not in use. The light attenuating shield absorbs emitted light from the cordless handpiece to minimize ocular radiation to the patient and user. The Valiant Curing Light is provided non-sterile. Disposable barrier sleeves (510(k) number K132953, TIDI Shield, Model 21102, by TIDI Products) assist in mitigating patient contamination; additionally, the handpiece, charging base and light attenuating shield can withstand common surface disinfectants. Also included in the Valiant Curing Light is an instructions for use. The instructions for use details the function and four independently operable settings of the device: 1) standard curing mode, 2) ramp curing mode, 3) boost curing mode, and 4) white light mode (visualizing of dental anatomy). The white light mode can be used for intraoral illumination to aid in the visualization of dental anatomy (i.e. equivalent to a class I dental operating light, CFR 872.4630). The curing light modes 1-3 provide broad spectrum blue light (400 - 500mm, with peaks at 410nm and 475nm) to cure a variety of dental restorative materials and adhesives utilizing the most common photoinitiators (CQ and PPD). The white light mode 4 provides an aid for illuminating dental anatomy.
The document describes the Valiant Curing Light, a dental device for curing photo-activated dental restorative materials and adhesives. The submission aims to demonstrate substantial equivalence to a predicate device, the Valo Cordless (K110582).
Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets these criteria:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" for performance in a table format with pass/fail thresholds. Instead, it demonstrates performance by comparing the Valiant Curing Light to its predicate device, the Valo Cordless, and asserting "statistically similar" or "equivalent" performance in various non-clinical tests.
However, based on the non-clinical performance testing sections, we can infer the implied acceptance criteria:
| Acceptance Criteria (Implied from Bench Testing Goals) | Reported Device Performance (Valiant Curing Light) |
|---|---|
| Composite Hardness: Effectively cure dental composite to depths of 2mm, with statistical similarity to the predicate device. | Hardness measurements from cured composite pucks using the Valiant Curing Light were statistically similar to those obtained with the Valo Cordless. Testing confirmed the Valiant adequately cures dental composite to depths of 2mm. (DHF 10018 TR002) |
| Wavelength Spectrum: Matches design criteria and is nearly identical to the predicate device. | The spectrum emitted from the Valiant matches design criteria. Comparison testing showed both curing lights emit nearly identical wavelength spectrums for curing dental materials. (DHF 10018 TR003) |
| Optical Power: Matches design criteria and is identical to or lower than the predicate device. | The Valiant's optical power matches design criteria. Comparison testing showed the Valiant has identical or lower optical power results compared to the Valo. The light attenuating shield blocks >99% of emitted optical power. (DHF 10018 TR004) |
| Heat Generation: Does not reach unsafe temperatures within typical use. | Testing concluded that the Valiant Curing Light did not reach unsafe temperatures within typical use. No hazard or warning statement is required. (DHF 10018 TR001) |
| Software Functionality: Software functions properly and complies with FDA guidance. | Software was developed in full compliance with the 2005 FDA Software Guidance. Testing verified that the Valiant's software functions properly. (DHF 10018 TR005) |
| Electrical Safety & EMC: Complies with relevant standards. | The Valiant Curing Light complies with IEC 60601-1 for electrical safety and electromagnetic compatibility. |
| Biological Evaluation: Complies with relevant standards. | The device complies with ISO 10993-1 (Biological Evaluation of Medical Devices). |
| Radiation Safety: Complies with relevant standards (ADA 48, IEC 62471). | The device complies with ADA 48 / ISO 10650-2 (radiation safety) and IEC 62471 (Photobiological Safety). |
Study Details
The document relies solely on non-clinical (benchtop) performance testing to demonstrate substantial equivalence. No clinical studies were deemed necessary.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for each test (e.g., number of composite pucks, number of light measurements). The descriptions refer to "testing concluded," "measurements obtained," or "comparison testing" without specifying the number of samples or repetitions beyond general terms.
- Data Provenance: The studies were non-clinical, likely conducted in a laboratory setting by Inter-Med / Vista Dental Products. There is no mention of country of origin of the data as it's not patient data, nor is it retrospective or prospective in the clinical sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable as the studies were non-clinical benchtop tests comparing physical properties and performance against a predicate device and engineering design specifications. The ground truth would be established by scientific measurement and engineering validation, not expert consensus in a clinical context.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This question is not applicable as there were no human readers or expert adjudications involved in establishing ground truth for these non-clinical tests.
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:
- This question is not applicable. This is a dental curing light, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This question is not applicable. This device is a physical tool (a curing light), not an algorithm. Therefore, "standalone" algorithm performance is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the non-clinical tests was established through objective physical measurements and engineering validation, comparing the device's performance against its own design specifications and against the measured performance of a legally marketed predicate device (Valo Cordless). For example, microhardness measurements would be taken using standardized laboratory techniques.
8. The sample size for the training set:
- This question is not applicable. The Valiant Curing Light is a physical device, not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established:
- This question is not applicable as there is no training set for this 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.