(30 days)
Polymerization of light-cured dental materials Polymerization of restorative composite materials Polymerization of bonding and sealing materials.
The Satelec Mini L.E.D. OEM Module 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. OEM Module is a universal photo-polymerization light curing source and producing visible blue light in the 430 to 480 nm waveband of the spectrum with a power density comprised between 1,000 400 mm Waveband of the Spottain Mar 2,000 W/cm2 (BoosterTip 5,5 mm lightguide).
This document describes a 510(k) premarket notification for the "Mini L.E.D. OEM Module," a polymerization light-curing device. The 510(k) process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new performance studies against specific acceptance criteria in the way a PMA (Premarket Approval) might.
Therefore, the information you're requesting regarding explicit acceptance criteria and a study proving those criteria are met, particularly with details like sample sizes, expert qualifications, and ground truth methodologies, is generally not found within a 510(k) summary for a device like this.
The "study" in this context is the comparison demonstrating substantial equivalence. The device's performance is reported relative to the predicate device's established performance.
Here's the breakdown based on the provided text, highlighting what is (and isn't) present:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied by Predicate) | Reported Device Performance (Mini L.E.D. OEM Module) |
|---|---|
| Intended Use: Photopolymerization of light-cured dental materials, restorative composite materials, and orthodontic bonding and sealing materials. | Same intended uses as the predicate device. |
| Wavelength: Visible blue light in the 430 to 480 nm waveband. | Produces visible blue light in the 430 to 480 nm waveband. |
| Power Density: Sufficient for intended uses (implied by predicate's efficacy). | Power density comprised between 1,000 and 2,000 W/cm2 (with BoosterTip 5.5mm lightguide), stated as "sufficient for the Mini L.E.D. product intended uses." |
| Safety and Efficacy: Safe and efficacious for its intended use (implied by predicate's clearance). | Stated as having "nearly identical characteristics and intended uses" to the predicate, which "has been determined to be safe and efficacious." |
| Classification: Ultraviolet Activator for Polymerization (21 C.F.R.§ 872.6070). | Classified as an Ultraviolet Activator for Polymerization (21 C.F.R.§ 872.6070). |
Explanation: In a 510(k), the "acceptance criteria" for the new device are essentially that it performs as safely and effectively as the predicate device for the same intended use. The performance of the predicate device (Satelec Mini L.E.D., K032465) sets the benchmark. The submitter asserts that the Mini L.E.D. OEM Module meets these, primarily by having "nearly identical characteristics and intended uses."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable in the context of this 510(k) summary. There is no mention of a clinical "test set" or patient data for evaluation of this device. The demonstration of equivalence is based on technical specifications and comparison to the predicate.
- Data Provenance: Not applicable.
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. This type of expert review for ground truth is typically associated with clinical performance studies or diagnostic device evaluations, which are not detailed in this 510(k) summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No adjudication method is mentioned as there is no "test set" requiring such.
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 polymerization light-curing device, not an AI-assisted diagnostic or imaging system. Thus, MRMC studies and AI assistance metrics are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a standalone medical device (light curing unit), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable in the typical sense. The "ground truth" for the predicate device's safety and efficacy would have been established through its own clearance process, likely based on performance testing and potentially clinical data (though not detailed here). For the OEM module, the "ground truth" is its demonstrated equivalence to the predicate's established performance.
8. The sample size for the training set
- Not applicable. There is no mention of a "training set" as this device does not involve machine learning or AI models that require training data.
9. How the ground truth for the training set was established
- Not applicable. See above.
Summary of 510(k) Approach:
The core of this 510(k) submission is the argument of substantial equivalence to a previously cleared device (Satelec Mini L.E.D., K032465). This is a regulatory pathway that relies on demonstrating that the new device has the same intended use and similar technological characteristics to a predicate device, and does not raise different questions of safety and effectiveness. Clinical studies with explicit acceptance criteria, detailed sample sizes, and ground truth establishment methods as you've requested are typically more prominent in PMA submissions or for novel devices, not for demonstrating substantial equivalence based on similar design and function.
§ 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.