(117 days)
The Skin Care Beauty Mask (Model: MJ-06) emits energy in the red and blue region of the spectrum, specifically indicated to treat full face wrinkles and/or mild to moderate acne.
The Skin Care Beauty Mask (Model: MJ-06) is a facemask-shaped device, which makes use of specific light spectral characteristics and directly applies light onto the face skin surface. The Skin Care Beauty Mask can emit two different kinds of wavelengths. The blue light (465nm) is intended to help reduce the appearance of mild to moderate inflammatory acne. Red light (640nm) is intended to improve the appearance of wrinkles. There are 150 LED lights with a center wavelength of 465nm and 150 LED lights with a center wavelength of 640nm, and the energy provided by each mode is 30mw/cm2 . The user wears the mask on their face for the treatment, and the device will shut down automatically after finishing a 5-minute treatment or 10-minute treatment selected.
The provided text is a 510(k) Summary for the Skin Care Beauty Mask (Model: MJ-06), which is a premarket notification to the FDA for demonstrating substantial equivalence to a legally marketed predicate device. This document focuses on demonstrating that the new device is as safe and effective as existing products, rather than proving a novel clinical benefit through extensive clinical studies with acceptance criteria and statistical analysis.
Therefore, the requested information regarding detailed acceptance criteria, specific study designs (like MRMC or standalone performance), sample sizes for test and training sets, expert qualifications, and ground truth establishment, is largely not present within this type of regulatory submission.
The "Test Summary" section primarily refers to bench testing against recognized safety and performance standards, not clinical trials to measure effectiveness against specific numerical acceptance criteria for clinical outcomes. The FDA clearance is based on substantial equivalence to a predicate device (K202390), indicating that its technological characteristics and intended use are similar enough not to raise new questions of safety or effectiveness.
Here's a breakdown of what can be extracted and what is missing, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable in the typical sense of clinical performance acceptance criteria. The "acceptance criteria" here are compliance with recognized electrical safety, EMC, and biocompatibility standards, and demonstrating substantial equivalence to a predicate device in terms of design, function, and intended use. The table below reflects the comparison to the predicate device and the standards met.
| Element of Comparison / Standard | Acceptance Criteria (Implicit: Similar to Predicate / Compliance with Standard) | Reported Device Performance |
|---|---|---|
| Intended Use / Indications for Use | To treat full face wrinkles and/or mild to moderate acne (similar to predicate) | The Skin Care Beauty Mask (Model: MJ-06) emits energy in the red and blue region of the spectrum, specifically indicated to treat full face wrinkles and/or mild to moderate acne. SE to predicate. |
| Wavelengths | Red: 640nm±10nm, Blue: 465nm±10nm (similar to predicate) | Red: 640nm±10nm, Blue: 465nm±10nm. SE to predicate. |
| Power Density | 30mW/cm² (similar to predicate) | 30mW/cm². SE to predicate. |
| Treatment Time | 5 or 10 minutes/day, 3 times per week (similar functionality to predicate) | 5 or 10 minutes/day, 3 times per week. SE to predicate. |
| Safety and EMC | Compliance with listed IEC/ANSI standards | Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-57. SE to predicate. |
| Biocompatibility | Compliance with listed ISO standards | Complies with ISO 10993-1, ISO 10993-5, ISO 10993-10. SE to predicate. |
| Overall Conclusion | Does not raise new types of questions of safety or effectiveness compared to predicate | Performance testing supports safe and effective use. Substantially equivalent to predicate K202390. |
2. Sample Size for the Test Set and Data Provenance
- Sample Size for Test Set: Not mentioned. The document primarily refers to "lab bench testing" (Section 6) against recognized standards and a comparison to a predicate device. There is no indication of a clinical "test set" with human subjects specifically for evaluating the effectiveness of the MJ-06 model in a clinical trial setting to establish new performance claims.
- Data Provenance: The document does not specify country of origin for any clinical data because detailed clinical performance data in a trial setting is not provided. It mentions the manufacturer as Shenzhen Kaiyan Medical Co Ltd, China, and a distributor in Denver, CO, USA. The "Test Summary" only lists engineering and biocompatibility standards.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not applicable. This information would be relevant for clinical studies where expert consensus or diagnostic interpretation is needed to establish ground truth for a test set. This document relies on compliance with engineering standards and comparison to a previously cleared device.
4. Adjudication Method for the Test Set
- Not applicable. As no clinical test set requiring expert adjudication is described, this information is not present.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. An MRMC study is a type of clinical study assessing diagnostic performance, usually comparing human readers with and without AI assistance. This document is a 510(k) submission for a physical light therapy device, not a diagnostic AI algorithm, and does not mention any such study.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical light therapy mask, not an algorithm.
7. The Type of Ground Truth Used
- For the technical and biocompatibility testing, the "ground truth" is compliance with the specified international standards (e.g., IEC 60601 series for electrical safety, ISO 10993 series for biocompatibility).
- For the overarching claim of effectiveness, the "ground truth" is established by the predicate device's prior clearance by the FDA for similar indications. The current device demonstrates substantial equivalence to this predicate.
8. The Sample Size for the Training Set
- Not applicable. This information is relevant for AI/machine learning models. The device is a hardware light therapy system.
9. How the Ground Truth for the Training Set was Established
- Not applicable.
In summary: The provided 510(k) summary is a regulatory document focused on demonstrating equivalency to a predicate device and adherence to safety standards. It does not contain the detailed clinical study data typically associated with a novel device proving its effectiveness against specific clinical acceptance criteria. The FDA's clearance (K220168) is based on the argument that the device is "substantially equivalent" to an already approved device (K202390) and meets relevant safety standards, meaning it does not raise new questions of safety or effectiveness.
§ 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.