Search Results

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.

Ask a specific question about this device

The Omnilux Revive and Omnilux Plus Combination is intended to emit energy in the red and infra-red region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.

The Omnilux Revive and Omnilux Plus are two sources of high spectral purity. They provide uniform or "hot-spot" free illumination. The outputs are pre-tuned to one wavelength with a narrow spectral bandwidth. The output of the Omnilux Revive is 633 + 5 nm, and the output of the Ommilux Plus is 830 + 5 nm. The base unit contains the power supplies and the control unit. Attached to the base unit are three folding arms. The LED head can be attached to the end of the ams and then positioned for patient treatment. The control unit consists of an LCD and keyboard together with the control clectronics. The user interface software allows the operator to access and control all device functions.

The provided 510(k) summary for the Omnilux Revive and Omnilux Plus Combination device does not include information about acceptance criteria or a study that proves the device meets specific performance metrics.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices (K030426 for Omnilux Revive and K043317 for Omnilux Plus). The argument is that because the combination device comprises two components previously deemed safe and effective, and no significant differences exist, it raises no new issues of safety or effectiveness.

Therefore, most of the requested information cannot be extracted from the provided text.

Here is what can be stated based on the given document:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. The document does not define specific performance acceptance criteria or report performance against such criteria. The device's "performance data" section states: "Based upon an analysis of the overall performance characteristics for the device, Photo Therapeutics Limited believes that no significant differences exist between the Omnilux Revive and the Omnilux Plus Combination, the previously approved Omnilux Revive (K030426) and the Omnilux Plus (which is the subject of 510K submission K043317). Therefore, the Omnilux Revive and Omnilux Plus Combination raises no new issues of safety or effectivencss."

2. Sample size used for the test set and the data provenance

Not applicable. No new study for the combined device is described that would involve a test set. The submission relies on the substantial equivalence of its components to previously cleared devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No new study for the combined device is described that would involve a test set requiring ground truth establishment by experts.

4. Adjudication method for the test set

Not applicable. No new study for the combined device is described that would involve adjudication.

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 not an AI-based diagnostic tool, but rather a light therapy device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this submission.

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

Not applicable. This is not an algorithm-only device.

7. The type of ground truth used

Not applicable. No new study requiring ground truth is described.

8. The sample size for the training set

Not applicable. This submission is not for an AI/ML device that requires a training set.

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

Not applicable. As above, this is not an AI/ML device requiring a training set.

Ask a specific question about this device