(137 days)
The intended use of the Solstice is for the polymerization of light-cured materials by dental professionals.
The Solstice is a Light Emitting Diode (LED) visible light used for the polymerization of light-cured materials by dental professionals. The Solstice consists of an LED curing handpiece and a charging system. The plastic molded handpiece contains an LED light engine, battery, and printed circuit board containing the electronics. A digital circuit and microprocessor will be utilized to control two (2) different curing modes (10 and 20 seconds). Each mode specifies LED curing output and audible beep timing. The Solstice uses a single pushbutton trigger to activate the LED curing output and select the curing mode.
This document describes the Solstice LED Curing Light, identified by K102621, and its substantial equivalence to the predicate device, Kerr Corporation's Demi. The device is intended for the polymerization of light-cured materials by dental professionals.
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state quantitative acceptance criteria or a direct comparison table for performance metrics between the Solstice and the predicate device. However, it mentions specific performance aspects for which data was submitted to demonstrate substantial equivalence.
| Performance Metric | Acceptance Criteria (Implicit) | Solstice Performance | Study/Proof |
|---|---|---|---|
| Biocompatibility | Non-toxic, non-irritating | Representative resin (similar to handle material) passed biocompatibility tests. | Statement from component manufacturer. |
| Depth of Cure | Comparable to predicate device | Data included in submission demonstrating performance compared to predicate. | Non-Clinical Test Data |
| Irradiance | Appropriate light intensity and peak wavelength for curing dental materials | Data included showing light intensity and peak wavelength. | Non-Clinical Test Data |
| Software Validation | Software functions as intended | Successfully validated. | Non-Clinical Test Data |
| Thermal Management | Does not require a cooling fan (i.e., operates within acceptable temperature limits without external cooling) | Temperature data demonstrated no cooling fan needed. | Non-Clinical Test Data |
| Light Output Stability | Constant light output during curing (unlike predicate which has shifting output) | Emits a constant light output. | Device Description / Non-Clinical Test Data |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" in the context of machine learning or AI. Instead, it refers to non-clinical tests conducted on the device itself or representative materials.
- Biocompatibility: "samples from typical production lots of the resin" were tested. No specific number is given.
- Depth of Cure, Irradiance, Thermal Management: Data was generated from testing the Solstice device. The sample size (number of devices, number of measurements) is not provided.
- Data Provenance: All data appears to be prospective and generated by Sybron Dental Specialties Inc. or its component manufacturers in the United States (Orange, CA, where the submitter is located).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is a medical instrument, not an AI/ML product where expert-established ground truth for a test set would be relevant. The performance evaluation is based on objective physical and chemical measurements.
4. Adjudication Method for the Test Set
Not applicable. As noted above, this relates to expert review of data for AI/ML models, which is not relevant here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement
Not applicable. This is a medical device, not an AI/ML diagnostic or assistive tool for human readers. No MRMC study was conducted.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This device is a physical instrument, not an algorithm.
7. The Type of Ground Truth Used
For the non-clinical tests:
- Biocompatibility: The "ground truth" is established by standard biocompatibility testing protocols, with the definition of "passing" those tests serving as the benchmark.
- Depth of Cure, Irradiance, Thermal Management: The "ground truth" is derived from direct physical measurements of the device's output and behavior, and comparison against established scientific/engineering principles for effective light curing and safety, as well as comparison to the predicate device's known performance.
- Software Validation: The "ground truth" is defined by the software requirements and specifications, with successful validation meaning the software performs according to these predefined criteria.
8. The Sample Size for the Training Set
Not applicable. This device does not involve machine learning and therefore does not have a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. See #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.