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The Omnilux Revive and Blue Combination is intended to emit energy in the red and blue region of the spectrum to treat dermatological conditions, specifically indicated to treat mild to moderate acne vulgaris.

The Omnilux Revive and Blue is a combination of two sources of high spectral purity. They provide uniform or "hot-spot" headwidth. The output pre-tuned to one wavelength with a narcow spectral bandwidth: Rlue is 415 + 2 wavelength of Omnilux Revive is 63 + 5 mm, and Omnilux Blue is 415 + 5m. The Omnilux base unit contains the III I FD hose same attached to the end of the arms and then positioned for patient to the lesting. The user interface an LCD and keyboard together with the control devices functions an LCD and Reyboard together while the reasonal control all device functions.

This 510(k) summary does not contain the detailed information necessary to fully address all aspects of your request regarding acceptance criteria and a definitive study proving the device meets those criteria. The document explicitly states:

"Based upon an analysis of the overall performance characteristics for the device, Photo Therapeutics Limited believes that no significant differences exist between Photo Therapeutics Eamined an' and the previously approved the Onlinex Revive (K030426) and Omnilux Blue (K030883) devices and their Omnilux Revive (R050+20) and Onlines Revive and Blue Combination raises no new issues of safety or effectiveness."

This statement indicates that the submission relies on the substantial equivalence to previously approved devices (Omnilux Revive and Omnilux Blue), rather than presenting a new, dedicated clinical study with defined acceptance criteria for the combination device. Therefore, a table of acceptance criteria and the performance of this specific combination device against those criteria is not provided in this document.

However, I can extract the available information and indicate where details are not present:

Here's a breakdown of the information provided, or where it's absent:

1. Table of Acceptance Criteria and Reported Device Performance:

This document does not provide a table of acceptance criteria or performance metrics for the Omnilux Revive and Blue Combination device in the context of a new study designed for this specific combination. Instead, it asserts substantial equivalence to previously approved Omnilux Revive and Omnilux Blue devices. Therefore, the "reported device performance" for this combination is inferred to be similar to its predicate devices for their respective indications.

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

• Sample Size: Not applicable/not stated. The document doesn't detail a new clinical test set for the Omnilux Revive and Blue Combination. It relies on the performance characteristics of its predicate devices.
• Data Provenance: Not applicable/not stated for a new study. The predicate devices were likely approved based on data (country of origin, retrospective/prospective) from their respective submissions (K030426 and K030883), but those details are not provided here for reference.

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

• Not applicable/not stated, as no new test set is described for this combination device.

4. Adjudication Method for the Test Set:

• Not applicable/not stated, as no new test set is described for this combination device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

• No, an MRMC comparative effectiveness study is not mentioned or implied for the Omnilux Revive and Blue Combination device. The submission focuses on substantial equivalence.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

• Not applicable. This is a light therapy device, not an AI or algorithm-based diagnostic tool. "Standalone performance" in this context would refer to the device's physical output and direct therapeutic effect, not an algorithmic assessment.

7. The Type of Ground Truth Used:

• Not applicable/not stated for a new study. For the predicate devices, "ground truth" for acne treatment would typically be clinical assessment by dermatologists, possibly using standardized photographic scales or lesion counts. However, this is not detailed for the combination device here.

8. The Sample Size for the Training Set:

• Not applicable/not stated, as this is not an AI/machine learning device that involves a "training set."

9. How the Ground Truth for the Training Set Was Established:

• Not applicable/not stated, as this is not an AI/machine learning device.

Summary of Device and Indication:

• Device Name: Omnilux Revive and Blue Combination
• Indication for Use: "To emit energy in the red and blue region of the spectrum to treat dermatological conditions, specifically indicated to treat mild to moderate acne vulgaris."
• Mechanism: Combines two sources of high spectral purity light:
  • Omnilux Revive: Wavelength of 633 ± 5 nm (red light)
  • Omnilux Blue: Wavelength of 415 ± 5 nm (blue light)
• Basis for Approval: Substantial equivalence to previously approved Omnilux Revive (K030426) and Omnilux Blue (K030883) devices. The manufacturer asserts that "no significant differences exist" and that "the Omnilux Revive and Blue Combination raises no new issues of safety or effectiveness."

To find detailed performance data and acceptance criteria, one would need to review the 510(k) submissions for the individual predicate devices: K030426 (Omnilux Revive) and K030883 (Omnilux Blue).

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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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