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Source of illumination for curing photo-activated dental restorative materials and adhesives.

Fusion Plus Curing Light is a portable dental LED curing light system. It provides a source of illumination for polymerization of photo-activated dental materials. The principle of operation is the same as the predicate devices: illumination for polymerization or curing of photo-activated dental materials. It uses our patented Fusion optical technology in combination with high-power LED to deliver high efficiency and high-power curing light.

The system consists of a curing handpiece, a charging stand, 100 barrier sleeves, light shields, a power adapter, and instructions for use. The handpiece is constructed of aluminum and consists of a main control, a light head, and a rechargeable battery assembly. The main control houses the control circuitry with microprocessor and user interface consisting of LCD display and two control buttons. A mode button selects operation timer and two curing modes: plasma or pulse mode. A ON/OFF button activates and deactivates the light. The handpiece is non-sterile utilizing the barrier sleeves for infection control. Similar to the predicate devices, the light shield and curing cap absorb emitted light and perform the function of eye protection. The charging stand allows for the placement of the handpiece in a holder with electrical connection to the power adapter as the source for charging the rechargeable battery. FUSION Plus has an interchangeable LED light head. Depending on the light head connected with the main control or added later, the kit can be configured in three options:

Trade Name: FUSION Plus, LED Peak Wavelength (nm): 395-480
Trade Name: FUSION Plus Standard, LED Peak Wavelength (nm): 440-480
The instructions for use detail the use of each head in curing of dental materials.

The DentLight FUSION Plus Curing Light is a dental LED curing light system designed for the polymerization of photo-activated dental restorative materials and adhesives. The manufacturer asserts its substantial equivalence to the predicate device Valo (K083647) by Ultradent Products Inc. and the reference device FUSION (K052593) by DentLight Inc., based on similarities in indications for use, technology, and performance test results.

Below is a detailed breakdown of the acceptance criteria and the study proving the device meets these criteria:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

The provided document does not specify a separate "test set" in the context of human data or image data for the FUSION Plus Curing Light. The non-clinical performance testing involved evaluating the device's functionality and performance directly, rather than using a dataset of clinical cases. The data provenance is essentially from the internal testing conducted by the manufacturer, DentLight Inc.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:

Not applicable. This device is a dental curing light, a physical device, not an AI or diagnostic tool that requires expert-established ground truth from clinical cases. The testing focused on the physical and electrical properties of the device.

4. Adjudication Method for the Test Set:

Not applicable, as no ground truth requiring adjudication was established from clinical or imaging data.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs Without AI assistance:

Not applicable. This device is a dental curing light and does not involve AI assistance for human readers or interpretation of medical images.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done:

Not applicable. This device is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):

Not applicable in the conventional sense. The "ground truth" for this device's performance is established by direct measurement of its physical and electrical characteristics against established industry standards and the performance of predicate devices. For instance, optical irradiance and spectral irradiance are directly measured and compared.

8. The Sample Size for the Training Set:

Not applicable. This device is a physical medical device, not an AI model that requires a training set.

9. How the Ground Truth for the Training Set was Established:

Not applicable. As there is no training set for an AI model, there is no ground truth to establish for it.

Study Proving Device Meets Acceptance Criteria:

The study that proves the FUSION Plus Curing Light meets its acceptance criteria is a series of non-clinical performance tests conducted by DentLight Inc. These tests were performed to evaluate the device's functionality, performance, safety, and substantial equivalence to the predicate devices. The study was guided by the FDA's "Dental Curing Lights – Premarket Notification [510(k)] Submissions" guidance document.

The non-clinical tests included:

• Device performance: This category covered specific technical parameters such as optical irradiance, spectral irradiance, curing time, curing modes and safety controls, and heat management.
• Software and hardware verification and validation: This ensured that the device's internal systems operate correctly and reliably.
• Risks to health and traceability analysis: This involved assessing potential hazards and ensuring the device's components and manufacturing processes are traceable.
• Electrical safety and electromagnetic compatibility (EMC): The device was tested for compliance with relevant electrical and safety standards, specifically IEC 60601-1, IEC 60601-1-2, and ANSI/ADA 48-2.

The conclusion drawn from these tests was that, based on similarities in indications for use and technology, coupled with the results from the performance testing, the FUSION Plus Curing Light is substantially equivalent to the predicate devices. The listed performance values in the table above demonstrate that the FUSION Plus Curing Light performs within acceptable ranges established by the predicate devices, and in some cases, exceeds them (e.g., Pulse/High curing optical intensity). Compliance with relevant IEC and ANSI/ADA standards confirms its safety and electromagnetic compatibility.

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