(190 days)
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.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.