(78 days)
The Neutrogena Light Therapy Aging Mask+ is an over the counter device that is indicated for the treatment of full face wrinkles.
The Neutrogena Light Therapy Aging Mask+ uses known LED light therapy technology for the treatment of facial wrinkles. The device emits a combination of red light and infrared light. Users place the lightweight mask over the face and press the "On" button on the controller module to start treatment. The device will automatically turn off after each 10-minute treatment.
The provided document focuses on the FDA's 510(k) clearance for the Neutrogena Light Therapy Aging Mask+ and primarily uses substantial equivalence to predicate devices, rather than establishing new acceptance criteria and proving the device meets them through clinical studies with specific performance metrics.
Therefore, the information required to answer your questions regarding acceptance criteria, study details, expert involvement, and ground truth establishment (as typically found in clinical trials for new efficacy claims) is not present in this document.
The document states: "Performance testing performed on the Neutrogena Light Therapy Aging Mask+ is sufficient to demonstrate that the subject device is as safe and effective as the legally marketed predicate devices." This indicates that the primary method for demonstrating effectiveness was through comparison to existing devices with established safety and efficacy profiles, rather than establishing new, quantitative performance criteria for wrinkle reduction itself.
However, I can extract the following information that is available:
1. Table of acceptance criteria and the reported device performance:
This document does not specify quantitative acceptance criteria for wrinkle reduction performance or report the device's performance against such criteria. Instead, it compares the technological characteristics and indications for use of the subject device to predicate devices to demonstrate substantial equivalence.
| Device Feature | Neutrogena Light Therapy Aging Mask+ (Subject Device) |
|---|---|
| Intended Use | Light-based treatment to reduce wrinkles on the body in general or specific anatomical area |
| Indications for Use | The Neutrogena Light Therapy Aging Mask+ is an over the counter device that is indicated for the treatment of full face wrinkles. |
| Wavelength (nm) | Red 620-640nm, IR 820-880nm |
| Intensity (mW/cm²) | 1.32 mW/cm² |
| Treatment Regimen | 10 minutes/day for 60 sessions |
| Total Energy Dose (J/cm²) | 47.58 J/cm² |
2. Sample size used for the test set and the data provenance: Not provided in the document for efficacy testing. The performance and safety testing mentioned are:
* Performance verification
* Human Factors Evaluation
* Biocompatibility testing
* Electrical Safety and Electromagnetic Compatibility testing
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided. This type of information would typically be relevant for studies involving qualitative assessments (e.g., by dermatologists for wrinkle severity), which are not detailed here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: 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. This device is 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 is a light therapy device, not an algorithm.
7. The type of ground truth used: Not explicitly stated for performance/efficacy, as the primary basis for clearance is substantial equivalence. For safety assessments, recognized standards (biocompatibility, electrical safety) serve as the "ground truth" or reference.
8. The sample size for the training set: Not applicable, as this refers to a medical device's clearance based on technological characteristics and comparison to predicates, not an AI model's training.
9. How the ground truth for the training set was established: Not applicable.
In summary, the FDA 510(k) clearance process for this device relies heavily on demonstrating substantial equivalence to pre-existing, legally marketed predicate devices, rather than presenting a novel clinical study with new, specific performance acceptance criteria for wrinkle reduction. The provided document details the technological characteristics and safety testing (bench, human factors, biocompatibility, electrical safety) that support this substantial equivalence claim.
§ 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.