(253 days)
The Omnilux Clear-U is intended to emit energy in the red and blue region of the spectrum, specifically indicated to treat mild to moderate acne on the face
The Omnilux Clear-U is a source of high spectral purity It provides uniform or "hotspot" free illumination The outputs are pre-tuned to a particular wavelength with a narrow spectral bandwidth The red output of the Omnilux Clear-U is 633 + 6 nm, and the blue output is 415 ± 5 nm The Omnilux Clear-U device itself contains a selector switch (red/off/blue), the LED array assembly, and arrangements for aur cooling A separate, universal, power supply converts mains AC power to the DC power requred by the Omnilux Clear-U Treatment time is controlled by the operator
The provided text describes the 510(k) summary for the Omnilux Clear-U device, which is an LED array for treating mild to moderate acne. However, it does not include acceptance criteria for device performance or a study that directly proves the device meets specific performance criteria in terms of clinical efficacy.
Instead, the submission relies heavily on demonstrating substantial equivalence to predicate devices (Omnilux Revive, Omnilux blue, Omnilux revive/Omnilux blue combination) by arguing that "no significant differences exist" and therefore "raises no new issues of safety or effectiveness."
The "Performance Data" section mentions two tests related to user comprehension and usability, but these are about the user interface and labeling, not the therapeutic efficacy of the light treatment itself.
Here's a breakdown based on the information available and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided document, there are no specific performance-based acceptance criteria for the clinical efficacy regarding acne treatment explicitly stated, nor is there reported device performance against such criteria.
The document focuses on usability and safety, as well as substantial equivalence to predicate devices.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Clinical Efficacy: (e.g., reduction in acne lesions by X% in Y weeks) | Not provided in the document. The submission relies on substantial equivalence to predicate devices for efficacy claims. |
| Usability Test Critical Objectives Comprehension Rate | Minimum comprehension rate of 88% at 95% confidence level |
| Self-Selection Test Critical Objectives Comprehension Rate | Minimum comprehension rate of 93% at 95% confidence level |
| Overall Performance Characteristics Analysis | Performed (stated to be a basis for belief in no significant differences), but specific results or metrics are not detailed. |
2. Sample Size Used for the Test Set and Data Provenance
- Self-Selection Test: A "sample representative population" was used. The exact sample size is not specified, but it was sufficient to determine a minimum comprehension rate of 93% at a 95% confidence level.
- Usability Test: A "sample representative population" was used. The exact sample size is not specified, but it was sufficient to determine a minimum comprehension rate of 88% at a 95% confidence level.
Data Provenance: Not explicitly stated, but given the submitter's address (Carlsbad, California) and the context of a 510(k) submission to the FDA, it is highly likely these tests were conducted in the United States. The document does not specify if these were retrospective or prospective studies; however, usability and self-selection tests are typically prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable for the reported tests. The self-selection and usability tests evaluate user comprehension and ability to use the device based on labeling, not clinical outcomes that would require expert ground truth.
4. Adjudication Method for the Test Set
Not applicable. No expert adjudication methods (like 2+1, 3+1) are described as the tests were user comprehension/usability evaluations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. The document does not mention any MRMC study. The comparison is made to predicate devices based on perceived "no significant differences" rather than a direct comparative effectiveness study involving human readers or clinicians.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. The Omnilux Clear-U is a therapeutic light device, not an AI or algorithm. Therefore, "standalone (algorithm only)" performance is not applicable. The device itself is the standalone therapy.
7. The Type of Ground Truth Used
For the usability and self-selection tests, the "ground truth" was likely defined by pre-established correct answers or critical objectives of the product labeling, against which user responses were measured for comprehension. For instance, correctly identifying the treatment duration or safety warnings.
For the inherent therapeutic claims, the "ground truth" (or basis of equivalence) relied on the established safety and effectiveness profile of the predicate devices, which would have been supported by their own clinical data (not detailed in this specific 510(k) summary).
8. The Sample Size for the Training Set
Not applicable as this is not an AI/ML device that requires training.
9. How the Ground Truth for the Training Set was Established
Not applicable as this is not an AI/ML device that requires training.
§ 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.