(83 days)
The Shani Darden LED light therapy mask 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.
The Shani Darden LED light therapy mask 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.
The Shani Darden LED light therapy mask is a home use wearable light emitting diode phototherapy device whose purpose is to produce an even, cool, narrow band of light for the treatment of full-face wrinkles and mild to moderate acne vulgaris of the face. The system consists of a hard-shell mask and a controller. The mask is worn on the face and is held in place by an adjustable Velcro strap. The LEDs produce blue, red and near infra-red (NIR) light in the visible spectrum (Blue: 415nm +/- 10nm, Red: 630nm +/- 10nm, NIR 830nm +/-10nm.). The device works by emitting the specified wavelengths into the skin in order to improve the appearance of wrinkles or to target bacteria that can cause acne vulgaris. The controller allows the user to select one of three treatment programmes (acne and wrinkles) and switches the LEDs ON/OFF, controlling power to the mask. The controller contains a simple graphical user interface (GUI) and three control buttons. The mask receives its power from a mains power adaptor.
The provided text describes the acceptance criteria and supporting studies for the Shani Darden LED light therapy mask, primarily focusing on non-clinical performance and a label comprehension study, rather than a clinical performance study.
Here's the breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a "table of acceptance criteria and reported device performance" as typically seen in clinical studies with specific endpoints. Instead, it relies on substantial equivalence to a predicate device and adherence to various safety and performance standards. The "performance" in this context refers to meeting those standards and demonstrating label comprehension.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Electrical Safety | |
| (Adherence to medical electrical equipment standards) | Conforms to IEC 60601-1:2005/AMD1:2012/AMD2:2020 |
| Electromagnetic Compatibility (EMC) | |
| (Adherence to standards for electromagnetic disturbances) | Conforms to IEC/EN 60601-1-2: 2015 |
| (Including FCC 47 CFR Part 15, Sub Part B) | |
| Home Healthcare Environment Safety | |
| (Adherence to specific safety requirements for devices used in home healthcare) | Conforms to IEC 60601-1-11:2015 |
| Non-Laser Light Source Equipment Safety | |
| (Adherence to particular requirements for therapeutic light sources) | Conforms to IEC 60601-2-57:2011 |
| Photobiological Safety | |
| (Adherence to standards for light source safety) | Conforms to IEC 62471:2008 |
| Biocompatibility | |
| (Evaluation and testing within a risk management framework for biological evaluation) | Conforms to ISO 10993-1: 2018 |
| Cytotoxicity | |
| (Tests for in vitro cytotoxicity) | Conforms to EN ISO 10993-5:2009 |
| Irritation and Skin Sensitization | |
| (Tests for irritation and skin sensitization) | Conforms to EN ISO 10993-10:2010 |
| Software Life Cycle Processes | |
| (Adherence to standards for medical device software) | Conforms to EN 62304: 2006 (ed. 1.0) |
| Risk Management | |
| (Application of risk management to medical devices) | Conforms to ISO 14971: 2019 |
| Label Comprehension and Safe/Effective Use by Lay Persons | |
| (Demonstrates that labeling can be used by lay persons to safely and effectively operate the device) | A label comprehension testing study was conducted. No new use errors, hazards, hazardous situations, or hazard-related use scenarios were discovered. The study concluded that the labeling could be used to safely and effectively operate the device for its intended use. |
| Similar Technical Characteristics to Predicate (K213184) | Intended Use: Same |
| Energy Type: LED phototherapy | |
| Wavelength Spectrum: Similar (Blue: 415nm +/- 10nm, Red: 630nm +/- 10nm, NIR 830nm +/-10nm) | |
| Power Density & Dose: Similar to predicate | |
| Treatment Time & Protocol: Identical to predicate | |
| Software Control: Both use software for treatment duration |
2. Sample size used for the test set and the data provenance
- Test set for Label Comprehension Study: 19 subjects
- Data Provenance: The document does not explicitly state the country of origin. It mentions subjects identified as Hispanic, Asian, and Indian, and that 8 subjects identified English as their second language, suggesting a diverse, possibly multi-ethnic, participant group. The study type is prospective, as it involved actively testing subjects with the device and its labeling.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The text does not mention experts used to establish ground truth for the label comprehension study. The "ground truth" for this study was the subjects'
comprehension and ability to use the label safely and effectively, as observed during the test.
4. Adjudication method for the test set
The document does not describe an adjudication method for the label comprehension study, as it was directly observing user interaction and comprehension, which doesn't typically require expert adjudication in the same way clinical diagnoses do.
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
A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. The device is an LED light therapy mask, not an AI-assisted diagnostic tool, so such a study is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is a physical LED light therapy mask, not an algorithm, and its use inherently involves a human user (applying the mask).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the LED light therapy performance: The ground truth is established through substantial equivalence to a legally marketed predicate device (K213184 MZ Skin LightMAX Supercharged LED Mask 2.0) and adherence to recognized performance and safety standards. There is no explicit "ground truth" for clinical efficacy described in this submission, as clinical testing was not conducted.
- For the Label Comprehension Study: The ground truth was the observable comprehension and safe/effective operation of the device by lay users based on the labeling, assessed directly through the study.
8. The sample size for the training set
The document explicitly states: "Clinical testing was not needed for this 510(k)." Therefore, there was no training set for clinical performance. The device relies on non-clinical performance testing and substantial equivalence to a predicate.
9. How the ground truth for the training set was established
As there was no clinical training set, this question is not applicable. The device's foundation for regulatory approval is based on substantial equivalence and non-clinical safety/performance standards.
§ 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.