(7 days)
The FUSION Curing Light is a dental curing light that is intended for photopolymerization of dental resins, restorative composite materials, and orthodontic brackets, bonding, and sealing that are photo-polymerized in the 440 – 480 nm wavelength range.
The DentLight's FUSION Curing Light is a battery-powered cordless unit designed for curing VLC materials whose initiator systems are sensitive to light in the 440-480nm wavelength range of the visible spectrum. The unit is based on blue LED (light emitting diode) technology for light generation in the desired wavelength and Li-Ion rechargeable batteries.
The FUSION Curing Light includes:
- A handpiece with a focusing lens focusing light emitted from a single LED probe tip and controlled by built-in control electronics
- · A detachable rechargeable battery unit
- · A base unit that plugs into main power as the handpiece stand
- · An eye shield and disposable cap at probe tip
- · Disposable disinfectant barrier sleeves on the probe tube
The provided text describes the 510(k) summary for the FUSION Curing Light, which is a dental curing light. It discusses its intended use, technological characteristics, and performance testing. However, it does not contain specific acceptance criteria or detailed study results that would allow for a table of acceptance criteria versus reported device performance, or many of the other requested details for an AI/device study.
The document is a regulatory submission for a physical medical device, not an AI/ML-based device. Therefore, a significant portion of the requested information (e.g., sample size for AI, ground truth establishment, MRMC studies, standalone algorithm performance) is not applicable or present.
Here's what can be extracted based on the provided text, and where the requested information is not available:
Acceptance Criteria and Study Information for FUSION Curing Light
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly state specific numerical acceptance criteria for performance tests. It lists the types of tests conducted but does not provide the threshold values for success or the quantitative results achieved. Therefore, a complete table cannot be generated.
| Performance Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Optical Power | Not specified | Testing was conducted. (Specific values not provided) |
| Resin Curing Time | Not specified | Testing was conducted. (Specific values not provided) |
| Curing Range | Not specified | Testing was conducted. (Specific values not provided) |
| Optical Wavelength | 440-480nm range | Designed for 440-480nm range; testing was conducted. (Specific confirmation values not provided) |
| Electrical Safety | Compliance with IEC 60601 | Designed to comply; will comply. (Specific test results not provided) |
| Electromagnetic Compatibility | Compliance with IEC 60601-1-2 | Designed to comply; will comply. (Specific test results not provided) |
| Software and Hardware Verification and Validation | Not specified | Testing was conducted. (Details not provided) |
Notes:
- The document states that the "major difference between the proposed FUSION Curing Light and the predicate curing lights is the intensity of the light power delivered, the longer range of curing distance, size and weight." It also notes that "The increased light intensity of the proposed FUSION Curing Light allows the resin curing and tooth whitening agent activation to be conducted at faster speed. The longer range of curing distance enables more flexibility for operators." This implies performance benefits in these areas compared to predicates, but without quantitative acceptance criteria or results.
2. Sample Size for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document states "The following testing was conducted to evaluate the functionality performance..." but does not detail the number of units tested or specific samples used for each test.
- Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Not Applicable. This device is a physical dental curing light, not an AI/ML diagnostic or prognostic tool that requires expert-established ground truth for a test set.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
- Not Applicable. As per point 3.
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
- No. This is not an AI-assisted device. MRMC studies are not relevant to this type of regulatory submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable. For a physical curing light, "ground truth" would relate to measurable physical properties (e.g., light spectrum, power output, curing depth/hardness of resin), which are evaluated through standard industrial test methods. The document does not specify the exact methods or comparator "ground truth" materials/standards used for the resin curing tests, but it would be based on recognized dental material testing protocols.
8. The Sample Size for the Training Set
- Not Applicable. This device does not involve a "training set" in the context of AI/ML.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As per point 8.
§ 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.