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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

• 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.

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The LG BEAUTY LED MASK is an over the counter device that is intended for the use in the treatment of full face wrinkles.

The LG BEAUTY LED MASK is a device which allows emission of LED light in the RED (637 nm) and IR (854 nm) spectrum on to the face, which induces photobiological effect to the face for reduction of wrinkle. The LG BEAUTY LED MASK include the mask that contains LEDs on the inner surface, the controller which turns on and off the device, and the power supply unit that delivers electrical power to the controller for operation or for charging the battery contained in the controller. Users place the lightweight mask over the face, and use the controller to operate the LG BEAUTY LED MASK. The device will automatically turn off after each treatment. Emitted light from LEDs are not intended for ocular or ophthalmic treatment. To prevent irradiation of LED lights to eyes during the treatment, LG BEAUTY LED MASK has protective eyecup which blocks light energy from LEDs.

This document is a 510(k) premarket notification for the "LG Beauty LED Mask," seeking clearance from the FDA. It does not contain a study proving the device meets specific acceptance criteria based on clinical performance metrics (like sensitivity, specificity, accuracy, or effect sizes for human readers). Instead, it primarily focuses on demonstrating substantial equivalence to predicate devices through technical characteristics and non-clinical testing.

Therefore, many of the requested details about acceptance criteria, clinical study design, ground truth establishment, and multi-reader multi-case studies cannot be extracted from this document, as they were not performed or reported in this submission for this type of device.

Here's an attempt to answer the questions based only on the provided text, indicating where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present clinical performance data in the form of a table with specific acceptance criteria (e.g., minimum sensitivity, specificity) and corresponding device performance. Instead, substantiation for this OTC (Over-The-Counter) device focuses on technical equivalence to predicate devices and non-clinical testing for safety and basic function.

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

This document does not describe a clinical test set with a sample size for evaluating the device's efficacy in treating wrinkles. The "tests" mentioned are non-clinical (e.g., measurement of wavelength, power output, safety tests against standards).

• Sample Size: Not applicable for clinical testing as described here.
• Data Provenance: Not applicable for clinical data. The non-clinical tests were likely conducted in a controlled lab environment. The submitter is LG Electronics, Inc. from Republic of Korea (South Korea).

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

Not applicable. This type of information would be relevant for devices involving image interpretation or diagnostic accuracy studies, which is not the primary focus or justification described for this OTC LED mask.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set requiring ground truth 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 an LED mask for wrinkle reduction, not an AI-assisted diagnostic tool requiring MRMC studies.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is not an algorithmic device. The device's function is direct light emission for treatment.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc)

Not applicable for clinical efficacy. The "ground truth" for the non-clinical tests refers to the established standards (e.g., IEC, ISO) and the device's measured physical properties (e.g., measured wavelength, power output).

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning/AI device requiring a training set.

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

Not applicable. This is not a machine learning/AI device.

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