(86 days)
LED MASK EXCLUSIVE MD is an over the counter device that is indicated for the treatment of full face wrinkles with red light and infrared light and treat mild to moderate acne vulgaris of the face.
The LED MASK EXCLUSIVE MD is an over the counter device that is intended for the treatment of full face wrinkles with red light and infrared light and mild to moderate acne with blue light. This product irradiates the skin with blue light in the wavelength range of 400 ~ 440mm, red light in the wavelength range of 630 ~ 690mm, and infrared light in the wavelength range of 820 ~ 880mm. This product is designed as a portable personal medical device with a built-in battery, not a wired power supply. It is a mask-type product that is worn on the face. The operating mode of the product can be easily changed by hand. After connecting the charging adapter to the cradle, attach the main unit to the cradle to wirelessly charge the main unit with only the cradle. In addition, eye shield (for eye protection, opening/closing covers, vacuum cleaner towels, power cables, etc. are provided for convenient service use.
The provided document is a 510(k) summary for a medical device called "LED Mask Platinum Exclusive MD." This document primarily focuses on demonstrating substantial equivalence to predicate devices based on technical characteristics and intended use, rather than presenting a detailed study proving the device meets specific performance acceptance criteria for clinical efficacy.
Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment are not present in this regulatory submission for this type of device. The document generally discusses non-clinical tests for safety and performance standards, but not clinical efficacy studies with the requested level of detail.
Here's what can be extracted and what cannot be from the provided text:
1. A table of acceptance criteria and the reported device performance:
This document does not provide a table of acceptance criteria for clinical performance (e.g., reduction in wrinkles or acne) with corresponding reported device performance. It only states the intended uses related to wrinkles and acne. The "performance tests" mentioned are related to basic safety and essential performance according to international standards (e.g., IEC 60601-1, IEC 62471), not clinical efficacy.
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not applicable/not provided. This document does not describe a clinical performance test set with a patient sample size. The tests mention standards like IEC 60601-1 (electrical safety), IEC 62471 (photobiological safety), ISO 10993 (biocompatibility), and IEC 62304 (software), which are typically laboratory or bench tests, not patient studies.
- Data Provenance: Not applicable/not provided. Since no clinical study is described, there's no information on data origin (country, 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 provided. No clinical test set with human subject data requiring expert ground truth establishment is described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/not provided. No clinical test set 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/not provided. This device is an LED mask, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable/not provided. This device is not an algorithm, but a hardware device (LED mask).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable/not provided. No clinical ground truth was established for the performance evaluation detailed in this document. The "tests" refer to compliance with safety and electrical standards.
8. The sample size for the training set:
- Not applicable/not provided. This document relates to a hardware medical device (LED mask), not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable/not provided. As above, this is not an AI/ML device requiring a training set.
Summary of Device Information Available in the Document:
Device Name: LED Mask Platinum Exclusive MD (Trade Name: LED MASK EXCLUSIVE MD)
Indications for Use: Over the counter device indicated for the treatment of full face wrinkles with red light and infrared light, and to treat mild to moderate acne vulgaris of the face.
Technology: Emits light at specific wavelengths (415 nm, 655 nm, 845 nm).
Regulatory Class: Class II
Non-clinical tests performed (focused on safety and device performance under standards, not clinical efficacy):
- Basic safety and essential performance (ES 60601-1)
- Photobiological safety (IEC 62471:2006)
- Basic safety and essential performance of non-laser light source equipment (IEC 60601-2-57:2011)
- Basic safety and essential performance in home healthcare (IEC 60601-1-11:2015)
- Risk management (ISO 14971)
- Usability (IEC 60601-1-6:2010)
- Biocompatibility (ISO 10993-11:2017, ISO 10993-5:2009, ISO 10993-10:2010)
- Software lifecycle process (IEC 62304:2006, FDA Guidance for Content of Premarket Submissions for Software)
- Electromagnetic compatibility (IEC 60601-1-2:2014)
- Sterility and Shelf Life (not supplied sterile, shelf life recorded per ISO 14971)
This 510(k) summary aims to demonstrate substantial equivalence to predicate devices (MMSphere and LED Mask Platinum MD) for its intended use, based on similar technology and non-clinical safety/performance evaluations. It does not contain primary clinical study data or detailed efficacy trial results.
§ 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.