(255 days)
CL-DP40 (Dr's Light PRIME)/CL-DP40 (Dr's Light CHOICE)is a hand held LED polymerization light intended to cure dental composites using visible light.
This unit is a battery type wireless LED curing light. User can adjust light intensity and time by selecting six program modes. Both of Dr's Light PRIME and Dr's Light Choice are characterized by high power intensity, slim head height, large irradiation area (12mm), adjustable intensity power, highly readable color touch screen, 360° twistable head and big capacity of the battery.
The provided text describes a 510(k) premarket notification for a dental curing light, CL-DP40 (Dr's Light PRIME) / CL-DP40 (Dr's Light CHOICE). This submission aims to demonstrate substantial equivalence to legally marketed predicate devices.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly derived from the technical specifications of the predicate device, particularly the primary predicate, "Dr's Light 2" (K173157). The subject device is deemed substantially equivalent because its performance metrics are comparable or superior to the predicate.
| Acceptance Criteria (from Primary Predicate) | CL-DP40 (Dr's Light PRIME) / CL-DP40 (Dr's Light CHOICE) Reported Performance |
|---|---|
| Operational Modes: 7 Modes | 6 Modes (Note: The submission states this difference "does not raise a question in safety and performance") |
| Light Source: 8W LED | 8W LED |
| Power Source: Battery 3.7V | Battery 3.7V |
| Wavelength Range: 400nm-490nm | 400nm-490nm (Dr's Light PRIME), 440nm-490nm (Dr's Light CHOICE) |
| Accessories: Guide Tip, Shield | Guide Tip, Shield |
| Material Composition: Glass Guide Tip | Glass Guide Tip |
| Light Intensity: Max 1600W/cm² | Max 1600W/cm² |
| Peak Wavelength: 460nm & 405nm | 460nm & 405nm |
| Depth of Cure: 2.3mm (avg.) | 2.3mm (avg.) |
| Electrical Safety: IEC 60601-1 | IEC 60601-1 |
| EMC & EMI: IEC 60601-1-2 | IEC 60601-1-2 |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of a clinical study with patients or samples. Instead, non-clinical tests were performed on the device itself.
- Sample Size: Not explicitly stated for each test (e.g., how many devices were tested for depth of cure, electrical safety).
- Data Provenance: The tests were non-clinical, likely conducted in a laboratory setting. There is no information regarding country of origin or whether they were retrospective or prospective.
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 dental curing light, and the evaluation did not involve human interpretation of medical images or data requiring expert-established ground truth. The "ground truth" for its performance is based on established engineering and materials science principles and measurements (e.g., light intensity, depth of cure).
4. Adjudication method for the test set
Not applicable, as there was no test set requiring expert adjudication for ground truth.
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
Not applicable. This document is for a dental curing light, not an AI-powered diagnostic device. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device does not use an algorithm or AI. It is a manually operated medical device.
7. The type of ground truth used
The "ground truth" for the performance evaluation relies on:
- Physical measurements: For parameters like light intensity, peak wavelength, and depth of cure, standardized measurement techniques appropriate for dental curing lights would have been used. These measurements serve as the factual basis for performance.
- Engineering standards: Compliance with standards like IEC 60601-1 (Electrical Safety) and IEC 60601-1-2 (EMC & EMI) serves as the "ground truth" for electrical safety and electromagnetic compatibility.
8. The sample size for the training set
Not applicable. This device does not involve machine learning or AI, so there is no training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set.
§ 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.