(26 days)
The LG PRA.L DERMA LED MASK is an over the counter device that is intended for the use in the treatment of full face wrinkles.
The LG PRA.L DERMA 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. The LG PRA.L DERMA LED MASK includes 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 PRA.L DERMA 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 PRA.L DERMA LED MASK has protective eye-shield which blocks light energy from LEDs.
This document is a 510(k) summary for the LG PRA.L DERMA LED MASK, outlining its substantial equivalence to a previously cleared device (LG BEAUTY LED MASK). The information provided focuses on the device's technical specifications and intended use for wrinkle treatment, rather than an AI/ML algorithm's performance.
Therefore, many of the specific criteria related to AI/ML device testing (e.g., sample size for test set, number of experts for ground truth, MRMC studies, standalone performance, training set details) are not applicable or not explicitly stated in this type of FDA submission for a physical device like an LED mask.
However, I can extract the relevant information regarding the device's performance data and acceptance criteria based on the available text:
Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are implicitly tied to demonstrating substantial equivalence to the predicate device, specifically that changes in the modified device (LG PRA.L DERMA LED MASK) do not raise new questions of safety or effectiveness. The performance tests conducted are primarily non-clinical, focusing on confirming functionality and safety standards.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Intended Use Equivalence: Same indications for use as predicate. | Met. "The LG PRA.L DERMA LED MASK is an over the counter device that is intended for the use in the treatment of full face wrinkles." This matches the predicate's intended use. |
| Material Equivalence: Same or biocompatible materials. | Met. "The 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." The materials list is identical to the predicate device. |
| LED Emission Equivalence: Same wavelengths and power density. | Met. "RED (637 nm) and IR (854 nm)" for wavelengths, and "25 mW/cm² total" for LED power density are identical to the predicate. |
| Treatment Parameters Equivalence: Same treatment time/frequency. | Met. "9 minutes daily 5 days per week for 8 weeks" is identical to the predicate. |
| Safety and Performance Standards Compliance: Conformity to recognized standards. | Met. Non-clinical tests performed: |
- Measurement of wavelength, average output power, and total irradiance.
- IEC 60601-1 (Basic safety and essential performance).
- IEC 60601-1-2 (Electromagnetic disturbances).
- IEC 62471-1 (Optical hazard).
- ISO 14971 (Risk management).
- IEC 62366-1 (Usability).
The "performance test shown that there is no technical characteristic difference in the modified device." and "The external design changes do not raise any concerns regarding the device performance and safety." |
| No New Safety/Effectiveness Concerns: Differences (like number of LEDs) do not introduce new risks. | Met. The primary difference noted is the number of LEDs (160 in proposed vs. 120 in predicate). The submission implies that despite this difference in component count, the overall power density and intended effect remain equivalent and safe, as indicated by the "LED power: 25 mW/cm² total" being the same for both devices. |
Regarding Specific AI/ML-related Questions:
- Sample size used for the test set and the data provenance:
- Not applicable/Not specified. This is a physical device submission, not an AI/ML algorithm. Performance evaluation is based on non-clinical engineering tests (e.g., optical power, safety standards) and comparison of specifications to a predicate device, not a data-driven test set of patient images/records.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth, in the context of AI/ML, refers to clinically validated outcomes or expert annotations. For this device, "ground truth" is established through engineering specifications, compliance with medical device standards, and the safety/efficacy profile of the predicate device.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable.
- 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 a standalone personal cosmetic device for wrinkle treatment, not an AI-assisted diagnostic or interpretation tool for human readers.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is electro-optical hardware with a fixed treatment protocol, not an algorithm.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- The "ground truth" for this medical device's clearance is primarily based on engineering specifications, compliance with recognized safety and performance standards (e.g., IEC, ISO), and demonstration of substantial equivalence to a legally marketed predicate device. For wrinkle treatment devices, the efficacy (reduction of wrinkles) in clinical studies would typically serve as the "outcomes data" ground truth, but for a 510(k) based on substantial equivalence to a similar device, direct clinical outcome studies are often not required if the changes are minor and do not impact safety or efficacy. The document explicitly states "The performance test shown that there is no technical characteristic difference in the modified device." implying the predicate's established performance serves as the reference.
- The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a training set.
- How the ground truth for the training set was established:
- Not applicable.
§ 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.