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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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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.

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The Dermillume Pro1000 phototherapy lamp is intended for dermatological use by trained licensed practitioners, specifically for the treatment of mild to moderate inflammatory acne vulgaris.

The Dermillume Pro1000 device is a compact light source that delivers high intensity narrow band blue and red light to the body for the treatment of acne vulgaris. The light sources are narrow wavelength LEDs that supply a spectral output of 414 ± 5 nm (blue) and 633 ± 5 nm (red). The device supplies 20 and 10 mW/cm² for blue and red light, respectively, at 4.6 inches distance from the skin surface. The principal parts of the device are a light unit, positioning arm and firmware timer to control duration of exposure. Additional off-the-shelf electronic devices related to treatment data acquisition and storage may be supplied as user options.

The Care Electronics, Inc. Dermillume Phototherapy Device is a blue/red light acne treatment lamp (K043575).

Here's an analysis of its acceptance criteria and the supporting study, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "current clinical studies" and a "recent clinical acne treatment study" but does not specify the sample size for any test set from these studies. It also does not directly state the data provenance (e.g., country of origin) or whether the data was retrospective or prospective for these studies. The performance data specifically cited for Dermillume (irradiance, wavelength) comes from "bench testing."

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not provided in the document. The document refers to "recommendations of current clinical studies" and a "recent clinical acne treatment study" but does not detail how ground truth was established within those studies or if experts were involved in a consensus process for a test set specific to this device's submission.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size.

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. It focuses on the device's technical specifications and its substantial equivalence to predicate devices, along with general claims of efficacy and safety supported by unnamed "clinical studies" and "this technology" broadly.

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

The Dermillume Phototherapy Device is a physical light-emitting device for treatment, not an AI algorithm. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" does not apply to this device.

7. The Type of Ground Truth Used

The document refers to "recommendations of current clinical studies" and a "recent clinical acne treatment study" as supporting evidence for the efficacy of blue and red light therapy. However, the specific type of ground truth used (e.g., expert consensus on clinical severity scores, photographic assessment, microbiological culture for P. acnes, patient-reported outcomes) within these clinical studies or for this device's specific validation is not detailed. For the physical parameters (irradiance, wavelength), the ground truth is based on bench testing measurements against established specifications.

8. The Sample Size for the Training Set

The document does not provide information on a training set sample size. As a non-AI device, the concept of a "training set" in the context of machine learning does not apply. The device's design is based on established scientific principles of phototherapy and comparison to existing predicate devices.

9. How the Ground Truth for the Training Set was Established

As this is not an AI device, there is no training set in the machine learning sense, and therefore no ground truth establishment for a training set. The device's design and performance claims are based on engineering specifications and the scientific understanding of phototherapy for acne, benchmarked against predicate devices and existing clinical literature.

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