(266 days)
The Bluemoon is intended to polymerize resinous dental materials, restorative composite materials, and orthodontic brackets, bonding and sealing materials that are photopolymerized in the 385~515nm waveband of visible light.
The Bluemoon Dental Curing Light is an instrument for photopolymerizing dental materials and starting agents by irradiating them with visible light between 385-515nm wavelength. It offers four modes (HYPER, TURBO, LOW, and SOFT START) depending on the output intensity and irradiation time.
The FDA 510(k) clearance letter for the Bluemoon Dental Curing Light provides information on several aspects of device testing, but it does not detail acceptance criteria for all performance metrics, nor does it present the study in a format that directly addresses the specific questions about AI/human-in-the-loop and ground truth establishment for AI models. This device is a dental curing light, a hardware device, not an AI/ML software. Therefore, the concepts of "AI assistance," "human readers," "test set," "training set," "ground truth" as typically defined for AI/ML performance studies are not directly applicable here.
However, I can extract and interpret the provided information to answer the relevant questions as best as possible for a hardware medical device.
1. A table of acceptance criteria and the reported device performance
The document lists "Performance Data" which includes various properties and their corresponding values. These values can be interpreted as the acceptance criteria for those specific properties, and the implicit reported performance is that the device meets these criteria, as stated in the conclusion.
| Acceptance Criterion (Property) | Acceptance Value | Reported Device Performance |
|---|---|---|
| Irradiation time | SOFT START: 10 ± 1s | |
| LOW: 10 ± 1s | ||
| TURBO: 5 ± 1s | ||
| HYPER: 3 ± 1s | "All test results demonstrate that the materials chosen, the manufacturing process, and the design utilized for the Bluemoon met the established specifications necessary for consistent performance according to its intended use." (Implicitly, the device met these times.) | |
| Peak wavelength | Check that the wavelength maxima occur within 5% of 400 nm and 455 nm respectively. |
- Purple: 400nm ± 5%
- Blue: 455nm ± 5% | "All test results demonstrate that the materials chosen, the manufacturing process, and the design utilized for the Bluemoon met the established specifications necessary for consistent performance according to its intended use." (Implicitly, the device met these wavelength specifications.) |
| Polymerization strength measurement | ≥ 80 MPa | "All test results demonstrate that the materials chosen, the manufacturing process, and the design utilized for the Bluemoon met the established specifications necessary for consistent performance according to its intended use." (Implicitly, the device achieved ≥ 80 MPa.) |
| Depth of cure | ≥ 2.0 mm | "All test results demonstrate that the materials chosen, the manufacturing process, and the design utilized for the Bluemoon met the established specifications necessary for consistent performance according to its intended use." (Implicitly, the device achieved ≥ 2.0 mm.) |
| Light Probe temperature | ≤ 41 ℃ | "All test results demonstrate that the materials chosen, the manufacturing process, and the design utilized for the Bluemoon met the established specifications necessary for consistent performance according to its intended use." (Implicitly, the device maintained ≤ 41 ℃.) |
| Energy-saving mode | 60 ± 2s | "All test results demonstrate that the materials chosen, the manufacturing process, and the design utilized for the Bluemoon met the established specifications necessary for consistent performance according to its intended use." (Implicitly, the device functioned within 60 ± 2s for energy-saving mode.) |
| Turn off energy-saving mode | 1) Buzzer sounds once, - LCD on | "All test results demonstrate that the materials chosen, the manufacturing process, and the design utilized for the Bluemoon met the established specifications necessary for consistent performance according to its intended use." (Implicitly, the device demonstrated these behaviors.) |
| Auto power off | 10 minutes ± 2 seconds | "All test results demonstrate that the materials chosen, the manufacturing process, and the design utilized for the Bluemoon met the established specifications necessary for consistent performance according to its intended use." (Implicitly, the device auto-powered off correctly.) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document describes "performance bench testing" but does not explicitly state the sample size (e.g., number of devices tested, number of dental material samples cured) for each test. Given it's a hardware device, the "test set" would refer to the units of the device and the materials it acts upon, rather than a dataset of clinical cases. The provenance of the data is not specified; however, the company is based in the Republic of Korea. The testing would be prospective (i.e., new tests conducted on the manufactured device) rather than retrospective clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This question is not applicable to a hardware dental curing light. "Ground truth" for this device is established by objective physical measurements (e.g., wavelength, power output, temperature, polymerization depth and strength measured by calibrated instruments) rather than expert interpretation of images or clinical findings. Therefore, no experts in the sense of trained clinicians interpreting data were used for establishing ground truth for the performance tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable to a hardware dental curing light. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in clinical or image-based studies where expert consensus is required for ambiguous cases. The performance tests for this device involve objective measurements.
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. The Bluemoon is a dental curing light, not an AI-powered diagnostic or assistive tool. It does not involve "human readers" or "AI assistance."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The Bluemoon is a hardware device; there is no standalone algorithm to evaluate.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the performance data listed (Irradiation time, Peak wavelength, Polymerization strength, Depth of cure, Light Probe temperature, Energy-saving mode, Auto power off), the "ground truth" is established through objective physical measurements using calibrated instruments and standardized test methods. For biocompatibility, the ground truth is established by the results of specific biocompatibility tests (Cytotoxicity, Skin Sensitization, Intracutaneous reactivity) conducted according to ISO 10993 standards.
8. The sample size for the training set
This question is not applicable. The Bluemoon is a hardware device and does not involve a "training set" in the context of machine learning or AI models. Its design and manufacturing process are validated through engineering principles and bench testing.
9. How the ground truth for the training set was established
This question is not applicable as there is no training set for this hardware 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.