(107 days)
LED silicone mask (Models: LP-RVTGLWP-WHT, LP-RVTGLW-WHT, TLM200) 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.
LED silicone mask (Models: LP-RVTGLWP-WHT, LP-RVTGLW-WHT, TLM200) is an over-the-counter device intended to emit energy in the red and Near Infra-red spectrum and is intended for the use in the treatment of full-face wrinkles.
LED silicone mask (Models: LP-RVTGLWP-WHT, LP-RVTGLW-WHT, TLM200) is an over-the-counter light emitting diode (LED) device that emits energy for use in dermatology for the treatment of acne and wrinkles. The device has anti-wrinkle mode and anti-acne, the former is to emit red light (630nm) and infrared light (830nm) to treat wrinkles, the latter is to emit red light (415nm) to treat mild to moderate acne.
This device contains Removable Eye Protection, Shell (Inner surface) and Shell (Outer surface), and a controller. Removable Eye Protection is designed to protect the user's eyes from light damage.
There are four buttons on the controller, which are setting button, left and right selection button and power button. Press the setting button, and then press the "left" or "right" button to select R/BLUE and R/N/R modes. The power button controls the device's on/off, pause and start.
There are three models of device, with only a slight difference in appearance. All wavelength, output mode and energy are same.
The provided text is a 510(k) summary for an LED silicone mask, which is a medical device. This document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. It explicitly states that clinical testing was not needed for this 510(k) and therefore does not contain acceptance criteria for device performance based on patient outcomes, nor does it describe a study that uses such criteria.
Therefore, many of the requested sections regarding acceptance criteria, reported performance, clinical study details, expert involvement, and ground truth establishment cannot be fulfilled from the provided text.
Here's a breakdown of what can and cannot be answered based on the input:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria related to clinical performance (e.g., reduction in acne lesion count or wrinkle severity) or reported device performance in terms of clinical outcomes. The "acceptance criteria" discussed are for non-clinical tests (electrical safety, biocompatibility, software, usability), and the "reported device performance" refers to the device's conformance to these standards.
| Acceptance Criteria (Non-Clinical Standards Conformance) | Reported Device Performance |
|---|---|
| Electrical Safety & EMC: | |
| IEC 60601-1 Ed. 3.2 | Conformed |
| IEC 60601-1-11 Ed. 2.1 | Conformed |
| IEC 60601-2-57 Ed. 1.0 | Conformed |
| IEC 60601-1-2 Ed. 4.1 | Conformed |
| IEC 62133-2 Ed. 1.0 (Lithium systems) | Conformed |
| IEC/TR 60601-4-2 (EMC immunity guidance) | Conformed |
| Biocompatibility: | |
| ISO 10993-5 (Cytotoxicity) | Conformed |
| ISO 10993-10 (Irritation & Sensitization) | Conformed |
| ISO 10993-23 (Irritation) | Conformed |
| Software V&V: | |
| FDA's Guidance for Software Contained in Medical Devices | Conducted and documented |
| Usability: | |
| IEC 62366-1 | Complies |
| IEC 60601-1-6 | Complies |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. No clinical test set or data provenance (country/retrospective/prospective) is described because no clinical study was performed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No clinical ground truth was established as no clinical study was conducted.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set or adjudication method 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, not an AI system that assists human readers. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an LED mask with fixed light emission, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For the non-clinical tests, the "ground truth" is adherence to the specified international standards. No clinical ground truth was established.
8. The sample size for the training set
Not applicable. As this device is not an AI/ML algorithm, there is no "training set."
9. How the ground truth for the training set was established
Not applicable. As this device is not an AI/ML algorithm, there is no "training set" or ground truth for one.
§ 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.