(86 days)
The Omnilux CLEAR acne facemask is an over-the-counter device intended to emit energy in the red and blue region of the light spectrum, specifically indicated to treat mild to moderate acne vulgaris on the face.
The Omnilux CLEAR consists of:
- Silicon flexible face mask
- Controller
- Power supply and country specific adaptors
- USB C to USB A connector
- 2 x Velcro Straps
The Omnilux CLEAR acne facemask is an over-the-counter device intended to emit energy in the red and blue region of the light spectrum, specifically indicated to treat mild to moderate acne vulgaris on the face. The system consists of a flexible silicon mask (1) that contains light emitting diodes (LEDs) and a controller (2). The LEDs generate the light. The mask is worn on the face and is held in place by two adjustable Velcro straps (5). The mask compromises of 2 surfaces. An inner surface that contacts the skin and an outer surface. Both surfaces are constructed of medical grade silicon.
The controller (2) switches the LEDs ON/OFF and controls power to the mask. The controller contains a rechargeable Lithium-ion polymer battery. The controller uses a visible display comprising of 3 micro-LEDs to show the user the battery charge status of the device.
The power supply (3) is used to charge the Lithium battery and is connected to a suitable mains outlet via a 2 or 3 pin input socket and wall plug. The power cable is connected to the controller by a standard micro-USB A-C connector (4). The Omnilux CLEAR mask cannot be operated while charging.
The equipment is not used to make measurements of any sort, or to draw any conclusions regarding the indication to treat. The equipment does not require checks on the light output as the LEDs do not dim with age to any practical extent.
The provided document is a 510(k) premarket notification for the Omnilux CLEAR device, intended for treating mild to moderate acne vulgaris. It focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing a clinical study with acceptance criteria and performance data in the typical sense of a comparative effectiveness study for an AI/ML algorithm.
Therefore, many of the requested details about acceptance criteria, ground truth establishment, expert adjudication, MRMC studies, and standalone performance for an AI/ML device are not present in this document because it describes a light therapy device, not an AI/ML system.
However, I can extract information related to the device's performance based on the provided text, particularly concerning its comparison to predicate devices and the non-clinical testing performed.
Here's an analysis of the provided text in the context of your request:
1. A table of acceptance criteria and the reported device performance
The document does not present "acceptance criteria" for clinical performance in the way an AI/ML algorithm might (e.g., target specificity, sensitivity, or AUC threshold). Instead, it demonstrates substantial equivalence to predicate devices by comparing technological characteristics and intended use. The "performance" is implicitly tied to meeting similar specifications as the predicates and demonstrating general safety and functionality through non-clinical testing.
Here's a table summarizing the device's characteristics compared to predicates, which are implicitly its performance against established acceptable characteristics for such devices:
| Characteristic | Acceptance Criteria (Predicate K160691) | Reported Device Performance (Omnilux CLEAR) | Remarks |
|---|---|---|---|
| Intended Use | Treat mild to moderate acne vulgaris | Treat mild to moderate acne vulgaris | Identical |
| Device Classification | Class II | Class II | Identical |
| Product Code | OLP | OLP | Identical |
| Energy Type | Light emitting diodes | Light emitting diodes | Identical |
| Peak Wavelength (Red) | 633 ± 4nm | 630nm +/- 5nm | Equivalent |
| Peak Wavelength (Blue) | 442 ± 4nm | 412.5nm +/- 7.5nm | Equivalent |
| Intensity (Blue) | 26.5 mW/cm² | 28 mW/cm² | Equivalent |
| Intensity (Red) | 7.5 mW/cm² | 16 mW/cm² | Equivalent |
| Total Intensity | 34 mW/cm² | 44 mW/cm² | Equivalent |
| Treatment Time | 6 minutes | 10 minutes | Equivalent |
| Dose (Blue) | 9.6 J/cm² | 16.8 J/cm² | Equivalent |
| Dose (Red) | 2.6 J/cm² | 9.6 J/cm² | Equivalent |
| Treatment Protocol (Freq.) | Daily | 4 x weekly, 6 weeks | Similar (Differences are acceptable for light therapy devices) |
The justification for "equivalence" in parameters like wavelength, intensity, treatment time, and dose is that these differences "can be negated by appropriate clinical or scientific data demonstrating that the proposed device is as safe and effective as the predicate device, and that the proposed device does not raise any different questions of safety and effectiveness than the predicate device for the same intended use." In this case, the document argues that the non-clinical testing (electrical safety, EMC, photobiological safety, biocompatibility, software, risk management) addresses these differences, implying no new safety/efficacy concerns.
2. Sample size used for the test set and the data provenance
For the device itself (Omnilux CLEAR, a light therapy mask), there isn't a "test set" in the sense of a dataset of images/cases for an AI algorithm.
However, there was a label comprehension testing study, which can be considered a form of human factors "test set":
- Sample Size: 27 subjects
- Data Provenance: Not explicitly stated, but the study implies it was conducted with participants, presumably in a controlled environment. Retrospective/Prospective is not specified but usually, such studies are prospective. Country of origin not specified, but the submission is to the US FDA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable in the context of this 510(k) submission for a light therapy device. There was no medical "ground truth" to establish for a diagnostic AI system's performance.
For the label comprehension study:
- There were no "experts" establishing a ground truth in the medical sense. The "ground truth" for label comprehension was the correct understanding of the device's labeling by lay users, assessed against pre-defined correct answers to comprehension questions. The study assessed user comprehension, not medical ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for this type of device. No medical adjudication was performed as there was no diagnostic "test set" requiring it.
For the label comprehension study:
- No adjudication method like 2+1 was described. The study likely involved participants answering comprehension questions based on the labeling, and their answers were scored against a pre-determined correct set.
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
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI systems in diagnostic imaging, not for a light therapy device. The document explicitly states: "Since the Omnilux CLEAR mask raises no new questions in terms of safety and efficacy, clinical data is not required." This means no human-in-the-loop or clinical efficacy study was required for this 510(k) clearance due to the device's substantial equivalence to predicates.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML algorithm. It is a physical light therapy device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable for the device's therapeutic function, as clinical data was not required.
For the label comprehension study, the "ground truth" was simply the intended meaning and safe usage instructions contained within the device's labeling.
8. The sample size for the training set
Not applicable. This refers to AI/ML algorithms. The Omnilux CLEAR is a hardware device.
9. How the ground truth for the training set was established
Not applicable. This refers to AI/ML algorithms.
Summary of what was presented in the document:
The submission focuses heavily on demonstrating substantial equivalence of the Omnilux CLEAR to predicate light therapy devices (K160691 and K081307) based on:
- Identical intended use.
- Similar technological characteristics (energy type, wavelengths, intensities, doses, treatment times).
- Compliance with relevant non-clinical performance and safety standards (electrical safety, EMC, photobiological safety, biocompatibility, software life cycle, risk management).
- Label comprehension testing to ensure lay users can operate the device safely and effectively without professional medical intervention.
The document argues that because the Omnilux CLEAR is substantially equivalent to existing devices and presents no new questions of safety or efficacy, a full clinical study with human patients for therapeutic effectiveness was not required for its 510(k) clearance.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.