(182 days)
For MK-78, MK-04,
The LED Light Therapy Mask (Models: MK-78, MK-04) is an over the counter device that is intended for the use in the treatment of full-face wrinkles.
For MK66-H, EL00003
The LED Light Therapy Mask (Models: MK66-H, EL00003) 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 LED Light Therapy Mask (Models: MK66-H, EL00003) is an over the counter device intended to emit energy in the red and Near Infra-red spectrum and is intended for the treatment of full-face wrinkles.
The LED Light Therapy Mask is a home wearable light-emitting diode phototherapy device whose purpose is to produce an even, cool, narrow band of light for the treatment of full-face wrinkles, or mild to moderate acne vulgaris of the face.
The system consists of a flexible silicone mask that contains LEDs and a controller. The mask is worn on the face and is held in place by adjustable Velcro straps. The mask compromises of 2 surfaces. An inner surface that contacts the skin and an outer surfaces are constructed of silicone.
The controller contains a rechargeable Lithium battery, the power supply (adaptor) is used to charge the Lithium battery and is connected to a suitable mains outlet via a 2 or 3 pin input socket and wall plug. The LED Light Therapy Mask cannot be operated while charging.
The device is not used to make measurements of any sort, or to draw any conclusions regarding the indication to treat. The device does not require checks on the light output as the LEDs do not dim with age to any practical extent.
Models MK-78, and MK-04 produce red and near infra-red (NIR) light in the visible spectrum (Red: 630+/-5nm, NIR: 830nm) in intended to improve the appearance of wrinkles. The controller switches the LEDs ON/OFF and controls power to the mask. For MK-04, the cable for connecting with the controller is nondetachable, but the cable is detachable for MK-78. Model MK-04 contains many rose quartz crystals in inner surface for decoration purpose, the crystals do not contact with skin and there is no therapeutic effect.
Model MK66-H and EL00003 produce blue, red, and near infra-red (NIR) light in the visible spectrum (Blue: 415nm, Red: 630+/- 5nm, NIR: 830nm). The device works by emitting the specified wavelengths into the skin in order to improve the appearance of wrinkles or to target bacteria that can cause acne vulgaris. The controller switches the LEDs ON/OFF, controls power to the mask, and switches treatment modes. The cable for connecting with the controller is detachable. Both MK66-H and EL00003 have two pieces of removable eye protection which are for protect eyes from the light.
The provided document describes the safety and performance testing of an LED Light Therapy Mask (Models: MK-78, MK-04, MK66-H, EL00003) to support its 510(k) submission for market clearance. The device is intended for the treatment of full-face wrinkles and mild to moderate acne vulgaris of the face.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Standard/Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Safety & Performance | General requirements for basic safety and essential performance (IEC 60601-1:2005/AMD1:2012/AMD2:2020) | Test result is within the test acceptance range of the standard. | Pass |
| Electromagnetic disturbances (IEC 60601-1-2:2014+A1:2020) | No degradation of performance during test or Lower than limits of measurement. | Pass | |
| Requirements for medical electrical equipment and systems in home healthcare environment (IEC 60601-1-11:2015/AMD1:2020) | Device operates normally, and can provide basic safety and essential performance. | Pass | |
| Particular Requirements for Basic Safety And Essential Performance Of Non-Laser Light Source Equipment (IEC 60601-2-57:2011) | Test result is within the test acceptance range of the standard. | Pass | |
| Photobiological safety of lamps and lamp systems (IEC 62471:2006) | Test result is within the test acceptance range of the standard. | Pass | |
| Shelf Life Test | Device can meet the requirement of the performance test, Power Density test, and Leakage current test after accelerated aging and use. | Pass | |
| Biocompatibility | Biological evaluation of medical devices (ISO 10993-1:2018) | (Implicit: Device meets requirements for biological evaluation and risk management.) | (Details not provided beyond listing the standard, but assumed sufficient for clearance.) |
| Tests for In Vitro Cytotoxicity (EN ISO 10993-5:2009) | (Implicit: Device materials are non-cytotoxic.) | (Details not provided beyond listing the standard, but assumed sufficient for clearance.) | |
| Tests for irritation and skin sensitization (EN ISO 10993-10:2010) | (Implicit: Device materials do not cause irritation or sensitization.) | (Details not provided beyond listing the standard, but assumed sufficient for clearance.) | |
| Usability | Usability of medical devices (IEC 62366-1) and Usability for basic safety and essential performance (IEC 60601-1-6) | Device complies with standards. | Complies (Pass) |
| Software | Software verification and validation testing (FDA Guidance) | Documentation provided; software considered "moderate" level concern with no major safety issues. | Pass |
2. Sample size used for the test set and the data provenance
The document indicates that for the performance testing, the "test sample is the final, finished product." This suggests that presumably one or a few units of the final device were used for each non-clinical performance test. No specific sample size (N) for a test set of data or data provenance (e.g., country of origin, retrospective/prospective) is provided, as these were non-clinical bench tests (e.g., electrical safety, photobiological safety), not studies on patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The tests were non-clinical bench tests according to international standards (e.g., IEC, ISO). No human experts were required to establish ground truth as these tests evaluate device specifications and compliance rather than clinical outcomes or interpretations of medical images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As described above, no human adjudication was involved in these non-clinical performance tests.
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 light therapy mask, not an AI-assisted diagnostic or interpretive tool. Therefore, an MRMC study or evaluation of human reader improvement with AI assistance is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device does not involve an algorithm with standalone performance for diagnosis or interpretation. The device itself is the "standalone" treatment method.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical performance tests, the "ground truth" was compliance with established international standards (e.g., IEC, ISO) for electrical safety, electromagnetic compatibility, photobiological safety, and biocompatibility. For usability and software, compliance with relevant guidelines was the ground truth. There was no clinical ground truth (e.g., pathology, outcomes data) used in these tests since clinical trials were not performed.
8. The sample size for the training set
Not applicable. This device does not appear to utilize machine learning or AI models that would require a "training set" of data in the conventional sense for a software algorithm. The "training" here refers to the device's design and manufacturing processes adhering to established engineering and safety standards.
9. How the ground truth for the training set was established
Not applicable, as there is no mention of a training set for machine learning or AI. The "ground truth" for the device's design and manufacturing is established through adherence to recognized international standards and verification/validation processes for hardware and software components.
§ 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.