(142 days)
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.
| Acceptance Criteria (Type) | Reported Device Performance (Details) |
|---|---|
| Technical Equivalence | Demonstrated by comparing LED emission wavelengths, power, and treatment time to predicate devices (K163329 and K133896). |
| LED Emission (RED) | LG: 637 nm |
| LED Emission (IR) | LG: 854 nm |
| LED Power (total) | LG: 25 mW/cm² |
| Treatment Time | LG: 9 minutes daily, 5 days per week for 8 weeks |
| Non-Clinical Testing (Safety & Function) | Tested according to recognized consensus standards. |
| Basic Safety & Essential Performance | IEC 60601-1 (Tested and evaluated) |
| Electromagnetic Disturbances | IEC 60601-1-2 (Tested and evaluated) |
| Optical Hazard | IEC 62471-1 (Evaluated) |
| Risk Management | ISO 14971 (Recorded) |
| Usability | IEC 62366-1 (Documented) |
| Biocompatibility | "Portion of the device that touches patient body is made of polypropylene, polycarbonate plastic, and silicone, which have been used for other medical devices without any biocompatibility risk." (Implied acceptance based on material commonality) |
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.
§ 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.