FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

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.

AI/ML Overview

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:

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.

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.
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.
Adjudication method for the test set: Not applicable. No test set requiring adjudication is described.
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.
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.
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).
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.
How the ground truth for the training set was established: Not applicable. See point 8.

Summary

Regulation Number and Section

§ 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.