(55 days)
The MZ Skin LightMAX Supercharged LED Mask 2.0 is an over-the-counter device intended to emit energy in the red and blue region of the light spectrum, specifically indicated to treat mild to moderate acne vulgaris of the face.
The MZ Skin LightMAX Supercharged LED Mask 2.0 is an over-the-counter device intended to emit energy in the red and Near Infra-red spectrum and is intended for the use in the treatment of full-face wrinkles.
The MZ Skin LightMAX Supercharged LED Mask 2.0 (LightMAX) is a home use wearable light emitting diode (LED) phototherapy device whose purpose is to produce an even, cool, narrow band of light for the treatment of full-face wrinkles and mild to moderate acne vulgaris of the face.
The system consists of a flexible silicon mask and a controller. The flexible silicon mask is manufactured from (Genvan GA 3-9) and contains the light emitting diodes (LEDs) The LEDs generate the light. The mask is worn on the face and is held in place by adjustable Velcro straps.
The LEDs produce blue, red and near infra-red (NIR) light in the visible spectrum (Blue: 412.5nm +/- 7.5nm, Red: 630nm +/- 10nm, NIR 830nm +/-15nm.). The device works through non-thermal mechanisms called Photobiomodulation (wrinkles) and endogenous Photodynamic therapy (acne vulgaris).
The controller (ABSKF757 / Polyac-757) allows the user to select one of two treatment programmes (acne or wrinkles) and switches the LEDs ON/OFF, controlling power to the mask. The programs are selected by the user pressing and holding the appropriate power button. The controller contains a countdown timer that activates once the user has selected the appropriate treatment program and counts down from 10:00 minutes. The user may stop the treatment program during the 10 minutes by pressing the appropriate ON/OFF button.
The controller contains a rechargeable Lithium-ion polymer battery. The controller uses a visible display comprising of 3 micro-LEDs to show the user the battery charge status of the device. The power supply (SK01T-0500100Z) is used to charge the Lithium battery and is connected to a suitable mains outlet via a 2 or 3 pin (3) input socket and wall plug. The power cable is connected to the controller by a standard micro-USB A-C connector. The MZ Skin LightMAX Supercharged LED Mask 2.0 cannot be operated while charging.
The mask compromises of 2 surfaces. An inner clear surface that contacts the skin and an outer surface. Both surfaces are constructed of the same silicone (Methyl vinyl silicone rubber GENVAN GA 3 series GA9 series).
The inner surface contacts with the user's skin. Contact is restricted to normal intact skin and only for a duration of 10 minutes (treatment time). Methyl vinyl silicone rubber Genvan GA 3 series GA9 series has been tested to those tests specified under ISO 10993-5:2009 tests for in vitro cytotoxicity and ISO10993-10:2010 Tests for irritation and skin sensitization.
The equipment is not used to make measurements of any sort, or to draw any conclusions regarding the indication to treat. The equipment does not require checks on the light output as the LEDs do not dim with age to any practical extent.
The provided text does not describe acceptance criteria and a study proving a device meets them in the typical sense of a clinical or performance study with quantitative outcomes. Instead, it details the non-clinical performance testing and a label comprehension study for the MZ Skin LightMAX Supercharged LED Mask 2.0.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table of acceptance criteria for clinical performance (e.g., reduction in acne lesion count or wrinkle severity) and direct device performance against those criteria. The "performance" described pertains to compliance with various electrical, safety, and software standards, as well as label comprehension.
| Acceptance Criteria Mentioned (Implicit) | Reported Device Performance |
|---|---|
| Compliance with AAMI/ANSI ES60601-1:2005 (Electrical safety) | The device has been found to conform to this standard. |
| Compliance with IEC 60601-1-2:2014 (EMC) | The device has been found to conform to this standard, including FCC 47 CFR Part 15, Sub Part B. |
| Compliance with IEC 60601-1-11:2015 (Home healthcare environment) | The device has been found to conform to this standard. |
| Compliance with IEC 62471:2008 (Photobiological safety) | The device has been found to conform to this standard. |
| Compliance with IEC62133:2012 (Batteries) | The device has been found to conform to this standard. |
| Compliance with ISO 10993-1:2018 (Biological evaluation) | The device has been found to conform to this standard. |
| Compliance with EN ISO 10993-5:2009 (In vitro cytotoxicity) | The silicone material has been tested to this standard. |
| Compliance with EN ISO 10993-10:2010 (Irritation and skin sensitization) | The silicone material has been tested to this standard. |
| Compliance with EN 62304:2006 (Medical device software life-cycle) | Verification and Validation of the firmware/software provides evidence that it passes specified acceptance criteria and meets all requirements. |
| Compliance with ISO 14971:2012 (Risk management) | The device has been found to conform to this standard. |
| Label comprehension by lay users for safe and effective operation | The label comprehension and use test demonstrated that the labeling could be used by lay persons to safely and effectively operate the device. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: 24 subjects
- Data Provenance: The text does not explicitly state the country of origin but implies it was conducted by the submitter (MZ SKIN LTD, located in London, UK). It was a prospective study (a "study was conducted").
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This study was a label comprehension test conducted with lay users, not an assessment requiring expert ground truth in a clinical sense. Therefore, experts were not used to establish a "ground truth" for the test set; rather, the test assessed the ability of the lay users themselves to comprehend the labeling.
4. Adjudication Method for the Test Set
Not applicable. This was a label comprehension study, not a diagnostic or clinical efficacy study requiring adjudication of expert interpretations.
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
No, an MRMC comparative effectiveness study was not done. The device is a "LightMAX Supercharged LED Mask 2.0," which is a light-emitting device, not an AI-powered diagnostic or assistive technology 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 direct-to-consumer LED mask for acne and wrinkle treatment. It does not involve an "algorithm" operating in a standalone capacity like an AI diagnostic tool.
7. The Type of Ground Truth Used
The "ground truth" for the label comprehension study was implicitly the correct understanding and safe/effective operation of the device as intended by its design and instructions. The study assessed whether lay persons could achieve this understanding and operation based on the provided labeling. It's not "expert consensus," "pathology," or "outcomes data" in the conventional sense.
8. The Sample Size for the Training Set
Not applicable. This document describes a medical device, not a machine learning algorithm that requires a "training set." The label comprehension study itself involved 24 subjects.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an algorithm.
§ 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.