(78 days)
The Neutrogena Light Therapy Acne Mask+ is intended to emit energy in the red and blue region of the spectrum, specifically indicated to treat mild to moderate acne on the face.
The Light Therapy Acne Mask + uses a known light emitting diode (LED) therapy, noncoherent light, in the red and blue range to treat mild to moderate acne bearing similar methods of operation, treatment regimen, and the ability to be recharged as the predicate K170111. The reference device bears the same technological characteristics including anatomical design and biocompatible materials as the Light Therapy Acne Mask +. Consistent with the intended use of the predicate and reference device, the Light Therapy Acne Mask + uses blue light to kill acne causing bacteria and the red light to decrease inflammation. The user wears the mask over their face, like a pair of glasses, and presses the button on the integrated module - holding for one second - to initiate the treatment. The device has a continuous working time of 10 minutes and shuts off automatically. Each use counts as a single dose. The module contains rechargeable batteries. The module is then recharged prior to the next treatment via a micro USB cable.
The provided text describes the Johnson & Johnson Neutrogena Light Therapy Acne Mask+ and its substantially equivalent determination by the FDA. However, the document does not contain specific acceptance criteria, performance metrics, or study details in the format required by your request (e.g., sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, training set details).
This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed clinical trial results with specific performance criteria and statistical analysis. The "Performance Data" section primarily lists compliance with various electrical, safety, and biocompatibility standards, and a Human Factors evaluation, not clinical efficacy data in the typical sense of measuring device performance against defined clinical acceptance criteria.
Therefore, many of the requested fields cannot be filled from the provided text.
Here's a summary of what can be extracted and what is missing:
Neutrogena Light Therapy Acne Mask+
1. Table of Acceptance Criteria and Reported Device Performance
| Metric / Acceptance Criteria | Reported Device Performance |
|---|---|
| Clinical Efficacy: (Based on the document, specific clinical performance acceptance criteria and their corresponding empirical results are not provided. The claim is based on substantial equivalence to predicate devices.) | Not explicitly stated in terms quantifiable clinical efficacy metrics and acceptance criteria. The document states: "The bench performance tests demonstrated that the Light Therapy Acne Mask + is as safe, and as effective as the predicate device." This implies an equivalence, but specific metrics like "X% reduction in lesions" against a target are absent. |
| Safety: (Compliance with standards) | Demonstrated compliance with: |
- IEC 60601-1: 2005 + A1: 2012
- IEC 60601-1-11 Ed. 2.0 2015-01
- IEC 60601-1-2 Ed. 4.0 2014-02
- IEC 60601-1-6 Ed. 3.1 2013-10
- IEC 60601-2-57 Ed. 1.0 2011-01
- IEC 62471 Ed. 1 2006-07
- IEC 62133-1:2012
- ISO 10993-1 (biocompatibility) |
| Treatment Regimen: | 10 minutes/day (Matches predicate) |
| Wavelength (Blue): | 425-450nm (Comparable to predicate 440+/-5nm) |
| Wavelength (Red): | 620-640nm (Comparable to predicate 630+/-5nm) |
| Total 30-day Energy Dose (J/cm²): | 38.38 J/cm2 (Higher than predicate 23.76 J/cm2, implying potentially similar or greater efficacy/safety profile) |
2. Sample size used for the test set and the data provenance
- Not specified. The document mentions "bench performance tests" and a "Human Factors (HF) evaluation" but does not detail a clinical test set with sample sizes or data provenance (country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable / Not specified. The document does not describe a clinical study for which experts would establish ground truth on a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not specified.
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 therapy mask, not an AI diagnostic/assistance tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a light therapy mask, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not specified for clinical efficacy. The document implies that the "effectiveness" is demonstrated by substantial equivalence to predicate devices that treat acne with similar light therapy, and by meeting various safety and performance standards. No specific clinical ground truth (e.g., lesion counts, photographs assessed by dermatologists) is described in this 510(k) summary for this device's performance study.
8. The sample size for the training set
- Not applicable / Not specified. The device is not an AI algorithm requiring a training set in the specified context. If there was a clinical trial, its participant numbers would be the "sample size," but none are detailed here.
9. How the ground truth for the training set was established
- Not applicable / Not specified.
§ 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.