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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 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 Omnilux Plus is intended to emit energy in the IR spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue and temporarily increase local blood circulation where applied.

The Omnilux Plus is a near infra-red light source of high spectral purity. It provides uniform or "hot-spot" free illumination. The output wavelength is 830 ± 5 nm. The Omnilux Plus 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 arms and then positioned for patient treatment. The user interface consists of an LCD and keyboard together with the control electronics. The user interface software allows the operator to access and control all device functions.

The provided document is a 510(k) Summary for the Omnilux Plus device, which is an infrared lamp. It does not contain information about acceptance criteria or a study proving that the device meets those criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices and detailing the general information and indications for use.

Therefore, I cannot provide the requested information based on the given text. The document states "Based upon an analysis of the overall performance characteristics for the device, Photo Therapeutics Limited believes that no significant differences exist. Photo Therapeutics Limited believes that no anges of safety or effectiveness." This statement, however, is a general assertion rather than a description of an actual study with acceptance criteria and results.

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The Omnilux Revive is indicated for use in dermatology for treatment of superficial, benign vascular, and pigmented lesions.

The Omnilux Revive is an intense visible light source of high spectral purity. It provides uniform or "hot-spot" free illumination. The output is pre-tuned to one wavelength with a narrow spectral bandwidth. The output wavelength is 633 ± 5 nm. The Omnilux Revive 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 arms and then positioned for patient treatment. The control unit consists of an LCD and keyboard together with the control electronics. The user interface software allows the operator to access and control all device functions.

The provided text for K030426, "510(k) Summary of Safety and Effectiveness for the Photo Therapeutics Limited Omnilux Revive," does not contain specific acceptance criteria or details of a study demonstrating the device meets such criteria.

The document indicates that the submission is a 510(k) premarket notification, which relies on demonstrating substantial equivalence to legally marketed predicate devices rather than proving specific performance against predefined acceptance criteria through new clinical studies.

Here's a breakdown of why this information is missing based on the provided text:

• No detailed performance data: Section 6, titled "Performance Data," explicitly states: "Based upon an analysis of the overall performance characteristics for the device, Photo Therapeutics Limited believes that no significant differences exist. Therefore, the Omnilux Revive raises no new issues of safety or effectiveness." This statement refers to a comparison with predicate devices, not a new study with acceptance criteria.
• Reliance on substantial equivalence: The FDA letter (page 2-3) confirms the review is for a 510(k) premarket notification and that the device is deemed "substantially equivalent" to predicate devices. This regulatory pathway primarily assesses if a new device is as safe and effective as a legally marketed one, without necessarily requiring new clinical trials to establish de novo performance metrics.

Therefore, most of the requested information regarding acceptance criteria and a study to prove they are met cannot be extracted from this document.

However, based on the principle of substantial equivalence, the implicit "acceptance criteria" are that the device's performance characteristics (e.g., wavelength, spectral purity, indication for use) are comparable to established predicate devices.

Here's what can be inferred or stated as absent:

1. Table of acceptance criteria and reported device performance:

   Acceptance Criteria (Inferred from Substantial Equivalence to Predicate Devices)	Reported Device Performance (from K030426)
   Wavelength and Spectral Purity (comparable to predicate devices)	Output wavelength: 633 ± 5 nm; Narrow spectral bandwidth
   Intended Use (comparable to predicate devices)	Indicated for use in dermatology for treatment of superficial, benign vascular, and pigmented lesions.
   Safety and Effectiveness (comparable to predicate devices)	"no significant differences exist," "raises no new issues of safety or effectiveness."

   Note: The document
   does not explicitly state numerical acceptance criteria nor does it provide a formal comparison table against such criteria. The reported performance is what the device claims to output.

2. Sample size used for the test set and the data provenance: Not applicable. No test set or associated study is described in the provided 510(k) summary for establishing new performance metrics. The submission relies on existing data/knowledge of predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No test set requiring expert ground truth is described.

4. Adjudication method for the test set: Not applicable. No test set requiring adjudication is described.

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 a light source for dermatological treatment, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is a hardware light source, not an algorithm.

7. The type of ground truth used: Not applicable. No new ground truth was established for this submission. The basis is substantial equivalence to legally marketed predicate devices, which would have had their safety and effectiveness established through prior means (e.g., clinical evidence, recognized standards).

8. The sample size for the training set: Not applicable. This device is a medical device (light source) that seeks substantial equivalence based on its physical characteristics and intended use, not an AI algorithm requiring a training set.

9. How the ground truth for the training set was established: Not applicable. See point 8.

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The Omnilux Blue is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.

The Omnilux Blue is a visible light source of high spectral purity. It provides uniform or "hot-spot" free illumination. The output is pre-tuned to one wavelength with a narrow spectral bandwidth. The output wavelength is 415 + 5 nm. The Omnilux Blue 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 arms and then positioned for patient treatment. The control unit consists of an LCD and keyboard together with the control electronics. The user interface software allows the operator to access and control all device functions.

The provided text does not contain information about specific acceptance criteria or a detailed study with performance metrics for the Omnilux Blue device. Instead, it is a 510(k) summary indicating substantial equivalence to a predicate device, the Lumenis Clearlight (K013623).

Here's a breakdown of the information that is available and what is not:

1. Table of Acceptance Criteria and Reported Device Performance

Not available. The document states: "Based upon an analysis of the overall performance characteristics for the device, Photo Therapeutics Limited believes that no significant differences exist. Therefore, the Omnilux Blue raises no new issues of safety or effectiveness." This implies that the device is considered to perform similarly to the predicate, but no specific performance metrics or acceptance criteria are provided for the Omnilux Blue itself in this summary.

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

Not applicable, as no specific test set data or study details are provided.

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

Not applicable, as no specific test set data or study details are provided.

4. Adjudication Method for the Test Set

Not applicable, as no specific test set data or study details are provided.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not mentioned. The document does not describe any MRMC studies or a comparison of human readers with and without AI assistance.

6. Standalone Performance Study

Not mentioned. No details about a standalone algorithm performance study are provided. The document outlines the physical device and its intended use.

7. Type of Ground Truth Used

Not applicable, as no specific data or study details are provided that would require a ground truth definition.

8. Sample Size for the Training Set

Not applicable, as this is a physical medical device (LED light source) and not an AI/algorithm-based device that would typically have a training set.

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

Not applicable (see point 8).

Summary of available information from the provided text:

• Device Name: Omnilux Blue
• Indication for Use: Generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.
• Predicate Device: Lumenis Clearlight (K013623)
• Manufacturer's Claim: Substantially equivalent to the predicate, raising no new issues of safety or effectiveness.
• FDA Determination: FDA found the device to be substantially equivalent to legally marketed predicate devices.

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