(205 days)
The D-LUX is intended to polymerize resinous dental materials, restorative composite materials, and orthodontic brackets, bonding and sealing materials that are photo-polymerized in the 420~490nm waveband of visible light.
The D-Lux is a cordless LED curing light, which is intended to polymerize (set) resinous dental pit and fissure sealants or restorative materials by transmission of light through a rod. It is portable and battery rechargeable.
Here's a breakdown of the acceptance criteria and study information for the D-LUX device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Depth of Cure (via ISO 4049:2000) | 2.91mm (D-LUX) |
Notes:
- The document primarily relies on substantial equivalence to a predicate device (Cybird LED Curing Light).
- The key performance metric explicitly stated and compared is the depth of cure. The predicate device's depth of cure was 2.97mm, demonstrating the D-LUX device's comparable performance.
- The D-LUX also conforms to IEC 60601-1, IEC 60601-1-2, and ADA 48[2009] standards; however, specific acceptance values for these standards are not provided in this summary.
2. Sample Size Used for the Test Set and Data Provenance
The provided summary does not explicitly state the sample size used for the depth of cure test.
- Data Provenance: Not specified, but given the manufacturer is based in Korea and the testing aligns with international standards (ISO and IEC), it's likely the testing was conducted either in Korea or at a certified lab. The document does not indicate if the data was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable as the study described is a technical performance test (depth of cure measurement for a dental curing light) rather than a study requiring expert-established ground truth for diagnostic or interpretative tasks.
4. Adjudication Method for the Test Set
This information is not applicable for the same reason as point 3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not reported. The study focused on the technical performance of the device itself (depth of cure) and its equivalence to a predicate device, not on human reader performance with or without the device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not applicable as the D-LUX is a physical medical device (dental curing light), not an algorithm or AI solution. The "standalone" performance here refers to the device's intrinsic functional capabilities, which are assessed through the depth of cure test.
7. The Type of Ground Truth Used
The "ground truth" for the depth of cure test is established by the standardized measurement protocol outlined in ISO 4049:2000. This standard dictates how the depth of cure is measured, making the measurement itself the "ground truth" for the device's performance in this specific parameter.
8. The Sample Size for the Training Set
This information is not applicable as the D-LUX is a medical device, not an AI or machine learning model that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable (see 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.