(59 days)
Curing camphorquinone-based visible light cured (VLC) materials.
The SLED CURING LIGHT is a cordless battery-powered unit designed for curing VLC materials whose initiators are sensitive to light in the 450-475 nm wavelength region of the visible spectrum. The light is based on LED (light emitting diodes) technology for light generation. The SLED CURING LIGHT SYSTEM includes: Handpiece with an LED and control electronics, Tapered fiber-optic probe to deliver the light to a well-defined site, Battery for sustained electronic power, Base unit - charges battery - stores handpiece when not in use, Transformer to supply wall power to the base unit, Optional amber-colored eye shield. The SLED CURING LIGHT handpiece contains three switches: one trigger to turn the curing LED on and off and two mode switches to cycle the curing time and type through several different settings. The battery in the handpiece is contained in a user-serviceable compartment.
Here's an analysis of the provided information regarding the SLED CURING LIGHT SYSTEM, focusing on the absence of specific acceptance criteria and study details.
Based only on the provided text, there is no detailed information about acceptance criteria or specific studies that prove the device meets those criteria. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than presenting detailed performance data from a specific study with defined acceptance criteria.
The 510(k) process primarily relies on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device. This often involves comparing device specifications and intended use, and may include some performance data to confirm equivalence, but it doesn't typically require the same level of detailed clinical or performance study reporting as a PMA (Premarket Approval).
Therefore, I cannot populate the table or answer most of your detailed questions directly from the provided text.
Here's how I would present the information based on the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance | Comments |
|---|---|---|---|
| Intended Use | Curing camphorquinone-based visible light cured (VLC) materials. | "Curing camphorquinone-based visible light cured (VLC) materials." | The device's intended use matches the predicate. This is a functional equivalence, not a quantitative performance metric with an acceptance threshold. |
| Technological Characteristics | - Intended use, appearance, design (source placement, probe style, on-board radiometer, control circuit, handpiece style) substantially equivalent to K982318 (Spectrum™ 800 Curing Unit). |
- Intended use, operation (range of light emitted, curing time, cooling) substantially equivalent to K000393 (Nova Cordless Light). | "The SLED CURING LIGHT SYSTEM is substantially equivalent to K982318 in intended use, appearance and design, including source placement, probe style, on-board radiometer, control circuit, handpiece style."
"The SLED CURING LIGHT SYSTEM is substantially equivalent to K000393 in intended use, operation, including the range of light emitted, curing time, and cooling." | These are statements of substantial equivalence, which is the primary "acceptance criterion" for a 510(k). No specific quantitative performance metrics or thresholds are provided in this summary. The "performance data provided" is mentioned but not detailed. |
| Safety and Effectiveness | Implied to be safe and effective for indicated use. | "We believe the similarity of the SLED CURING LIGHT SYSTEM to the legally marketed predicate devices and the performance data provided support the safety and effectiveness of the SLED CURING LIGHT SYSTEM for the indicated use." | No specific safety or effectiveness metrics or studies are described. The conclusion is based on substantial equivalence to predicate devices, which are assumed to be safe and effective. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not specified. The document does not describe any specific test set for an independent performance study. The "performance data provided" is mentioned in a general way, but its nature, sample size, or provenance are not detailed.
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)
- Not applicable/Not specified. There is no description of a test set requiring expert ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not specified. There is no description of a test set requiring adjudication.
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 device is a curing light, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is a physical medical device, a curing light, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not specified. No specific ground truth methodology is described in this document. Substantial equivalence relies on comparing the device's characteristics and performance to known predicate devices.
8. The sample size for the training set
- Not applicable/Not specified. This is not an AI/machine learning device that would typically have a "training set."
9. How the ground truth for the training set was established
- Not applicable/Not specified. As above, no training set is described.
Summary of what the document does provide:
- Device Name: SLED CURING LIGHT SYSTEM
- Intended Use: Curing camphorquinone-based visible light cured (VLC) materials.
- Predicate Devices: Spectrum™ 800 Curing Unit (K982318) and Nova Cordless Light (K000393).
- Basis for Approval: Substantial equivalence to the predicate devices in intended use, appearance, design, operation, range of light emitted, curing time, and cooling. The document states that "performance data provided" supports safety and effectiveness, but it does not elaborate on what that data entails.
§ 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.