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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.

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.

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The Omnilux New-U is intended to emit energy in the red and IR region of the spectrum, specifically indicated to reduce periorbital wrinkles.
The Omnilux New-U is intended to emit energy in the red and IR region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.

The Omnilux New-U is a source of high spectral purity. It provides uniform or "hot-spot" free illumination. The outputs are pre-tuned to a particular wavelength with a narrow spectral bandwidth. The red output of the Omnilux New-U is 633 + 6 nm, and the IR output is 830 ± 5 nm. The Omnilux New-U device itself contains a selector switch (red/off/IR), the LED array assembly, and arrangements for air cooling. A separate, universal, power supply converts mains AC power to the DC power required by the Omnilux New-U. Treatment time is controlled by the operator.

The provided document describes the Omnilux New-U, a device intended to reduce periorbital wrinkles. However, it does not include detailed acceptance criteria or a specific study proving the device meets said criteria.

Instead, the submission relies on the assertion that its performance characteristics are not significantly different from previously approved predicate devices (Omnilux Revive, Omnilux plus, Omnilux revive/Omnilux plus combination). The FDA's 510(k) clearance process focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring new clinical efficacy trials for every new submission, especially for a device with a similar mechanism of action and intended use.

Therefore, many of the requested details about acceptance criteria, sample sizes, ground truth establishment, expert qualifications, and MRMC studies are not present in this 510(k) summary.

Here's a breakdown of what can be extracted and what information is missing:

1. A table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

• Not applicable / Not provided. The document does not describe a new clinical study to establish efficacy for the Omnilux New-U itself. Its clearance is based on substantial equivalence to predicate devices, for which clinical data would have been submitted in their respective 510(k)s.

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 / Not provided. Since no new clinical study data for the Omnilux New-U is presented, there is no mention of experts establishing ground truth for a test set.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not applicable / Not provided.

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 / Not provided. This device is for direct therapeutic application, not an AI diagnostic tool involving human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Not applicable / Not provided. This is a hardware device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Not applicable / Not provided for the Omnilux New-U. For the predicate devices, it would likely have involved clinical assessment of wrinkle reduction (e.g., photographic analysis by experts, patient self-assessment, or validated wrinkle scales).

8. The sample size for the training set:

• Not applicable / Not provided. No new clinical study data (and thus no training set) for the Omnilux New-U is presented.

9. How the ground truth for the training set was established:

• Not applicable / Not provided.

Summary of the Study (or lack thereof) provided:

The submission for the Omnilux New-U relies entirely on the concept of substantial equivalence to predicate devices (Omnilux Revive, Omnilux plus, Omnilux revive/Omnilux plus combination). The manufacturer, Photo Therapeutics Limited, asserts that "no significant differences exist" between the Omnilux New-U and these previously cleared devices in terms of "overall performance characteristics." Therefore, they argue the Omnilux New-U "raises no new issues of safety or effectiveness."

The FDA's clearance (K072459) of the Omnilux New-U indicates that they agreed with this assessment of substantial equivalence, allowing the device to be marketed. This is a common pathway for medical device clearance in the US, especially when new devices are similar in technology and intended use to existing ones. It means specific new clinical studies to prove efficacy were not required for this particular 510(k) submission.

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