(71 days)
photo-polymerization in the 430-490 nm waveband of visible light cured (VLC) dental materials,
photo-polymerization in the 430-490 nm waveband of visible light cured (VLC) restorative composite materials, and
photo-polymerization in the 430-490 nm waveband of visible light cured (VLC) orthodontic brackets, and orthodontic bonding and sealing materials.
The Satelec Mini L.E.D. product is classified as an Ultraviolet Activator for Polymerization (21 C.F.R.§ 872.6070) because it is a device intended for the photopolymerization of light cured dental materials, restorative composite materials, and orthodontic bonding and sealing materials. The Mini L.E.D. is a universal photopolymerization light curing source working in cordless conditions and producing visible blue light in the 430 to 490 nm waveband of the spectrum with a power density comprised between 1,000 W/cm² (Universal 7.5 mm light-guide) and 2,000 W/cm² (BoosterTip 5.5 mm light-quide).
This Satelec Mini L.E.D. Polymerization Light-Curing Device 510(k) submission (K032465) focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a standalone study with a defined test set, ground truth, and expert adjudication.
Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not explicitly available or applicable in the provided 510(k) summary. The submission primarily relies on comparing the device's characteristics and intended use to already cleared devices.
Here's an attempt to answer the questions based on the provided text, indicating where information is not present:
1. A table of acceptance criteria and the reported device performance
The 510(k) summary does not present a formal table of acceptance criteria with corresponding device performance metrics in the way a clinical study or performance verification test would. Instead, the "performance" is implicitly demonstrated through the device's specifications and comparison to predicate devices, particularly regarding its ability to achieve sufficient power density within the stated wavelength band for polymerization.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Produces visible blue light in the 430 to 490 nm waveband. | Produces visible blue light in the 430 to 490 nm waveband of the spectrum. |
| Power density sufficient for intended uses. | Power density comprised between 1,000 W/cm² (Universal 7.5 mm light-guide) and 2,000 W/cm² (BoosterTip 5.5 mm light-guide). These power densities are sufficient for the Mini L.E.D. product intended uses. |
| Capable of photo-polymerization of VLC dental materials. | Intended for photo-polymerization in the 430-490 nm waveband of visible light cured (VLC) dental materials. Shared intended use with predicate devices implies capability. |
| Capable of photo-polymerization of VLC restorative composite materials. | Intended for photo-polymerization in the 430-490 nm waveband of visible light cured (VLC) restorative composite materials. Shared intended use with predicate devices implies capability. |
| Capable of photo-polymerization of VLC orthodontic materials. | Intended for photo-polymerization in the 430-490 nm waveband of visible light cured (VLC) orthodontic brackets, and orthodontic bonding and sealing materials. Shared intended use with predicate devices implies capability. |
| Substantially equivalent to predicate devices for safety and effectiveness. | The Mini L.E.D. has nearly identical characteristics and intended uses as the Satelec ACTA (K961735), 3M ESPE Epilar Freelight (K011154), and GC America GC E-Light (K012134). Predicates are "well established and determined 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)
This information is not provided in the 510(k) summary. The submission does not describe a clinical or performance test set. The submission relies on technical specifications and comparison to predicate devices rather than new performance data from a "test set."
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)
This information is not provided as there is no described test set or ground truth established by experts within the context of a performance study in the 510(k) summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided as there is no described test set or adjudication process in the 510(k) summary.
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
A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted as this is a dental polymerization light-curing device. This type of study is more relevant for diagnostic AI devices where human reader performance is being evaluated with and without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A "standalone" performance study in the context of an algorithm or AI is not applicable here. This device is a physical light-curing tool. Its performance is inherent to its physical properties (wavelength, power density) and its ability to cure dental materials, not an "algorithm only" performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The concept of "ground truth" as typically defined for diagnostic or AI-driven devices is not directly applicable here. The "truth" for this device's function is its physical specifications (power density, wavelength output) and its ability to effectively polymerize various dental materials. This is assessed through physical measurements and material science principles, not expert consensus or pathology on a clinical dataset. The implicit "ground truth" for showing effectiveness is the established ability of the predicate devices to cure materials effectively.
8. The sample size for the training set
This information is not provided and is not applicable to this type of device. The device does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
This information is not provided and is not applicable to this type of device. There is no training set mentioned in the context of this 510(k) submission.
§ 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.