(198 days)
The Sapphire PAC Light is a source of illumination for curing dental restorative materials and is a source of illumination for tooth whitening activities performed in dentistry.
The Sapphire Supreme Plasma Arc Dental Curing Light consists of a xenon plasma arc light source (lamp), power supply with user interface controls, and a light guide with a priol-type handpiece with user interface compls. The light from the xenon arc lamp is transmitted through optical litters that largely eliminate unnecessary ultraviolet (UV), visible, and infrared (IR) wavelengths into the proximal end of the light guide, where it is conducted through a fiber-optic bundle and focused through a removable tip at the light guide. Controls on both the light source and the handpiece activate the lamp and time of exposure. The Sapphire PAC Light safely and effectively transmits blue light at wavelengths and with sufficient intensity to initiate photopolymerization of light-cured dental restorative naterials. Ultraviolet (UV) and infrared (IR) blocking filters are placed between the xenon arc lamp and the light guide. The wavelength of the blue light transmitted by the device is chosen to cure all common dental photoinitiators; its irradiant intensity is powerful enough to initiate rapid polymerization while not so strong as to be a thermal hazard.
The provided document is a 510(k) summary for a dental curing light, not an AI software or diagnostic device. Therefore, much of the requested information regarding AI-specific criteria (like expert adjudication, MRMC studies, training/test set details, and ground truth for AI models) is not applicable.
However, I can extract the relevant information regarding performance testing and acceptance criteria as described for this medical device.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Conformance to ANSI/ADA Specification No. 48, Visible Light Curing Units (2004) | Conforms to the requirements. |
| Conformance to normalized standards for electromagnetic compatibility | Conforms to the requirements. |
| Conformance to normalized standards for safety characteristics of medical equipment | Conforms to the requirements. |
| Safely and effectively transmits blue light at wavelengths to initiate photopolymerization of light-cured dental restorative materials. | Wavelength of blue light transmitted is chosen to cure all common dental photoinitiators. |
| Sufficient intensity to initiate rapid polymerization. | Irradiant intensity is powerful enough to initiate rapid polymerization. |
| Intensity not so strong as to be a thermal hazard. | Irradiant intensity is not so strong as to be a thermal hazard. |
| Presence of UV and IR blocking filters. | UV and IR blocking filters are placed between the xenon arc lamp and the light guide. |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of data used for algorithm validation as it's not an AI device. Instead, it refers to the physical device undergoing performance testing. The sample size for the device testing (e.g., how many units were tested) is not explicitly stated. The provenance of this physical testing data would be "in-house" or "laboratory testing" conducted by the manufacturer (Den-Mat Holdings, LLC).
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 physical product (dental curing light), not an AI algorithm requiring expert consensus for ground truth. Its performance is validated against established industry standards and physical measurements.
4. Adjudication method for the test set
Not applicable. This is not an AI algorithm 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 is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is established by conformance to recognized industry standards (ANSI/ADA Specification No. 48, Visible Light Curing Units (2004)) and normalized standards for electromagnetic compatibility and safety characteristics of medical equipment. This involves objective physical measurements and technical evaluations rather than human expert interpretation of data.
8. The sample size for the training set
Not applicable. This is not an AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI device that requires a 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.