(84 days)
The Project E Beauty LED Light Therapy Mask is an over the counter device that is indicated for the treatment of full face wrinkles and mild to moderate acne.
The Project E Beauty LED Light Therapy Mask is a facemask-shaped device designed for home-use, which uses Light Emitting Diodes to emit energy in the red, blue and infrared region of the spectrum. The Project E Beauty LED Light Therapy Mask has a total of 36 LEDs. The red light with wavelengths centered at 635-644nm and the infrared light with wavelengths centered at 845-855nm to treat wrinkles on the face. The blue light with wavelengths centered at 430-445nm and the red light with wavelengths centered at 635-644nm to treat mild to moderate acne on the face. The Project E Beauty LED Light Therapy Mask components include the LED module, USB power cord, and integrated module. The user wears the device over the face, like a pair of glasses, and presses the Power button on the integrated module for 1 second to initiate the treatment. The device has a continuous working time of 12 minutes and powers off automatically.
The provided text describes a 510(k) premarket notification for a medical device, the "Project E Beauty LED Light Therapy Mask". This document focuses on demonstrating substantial equivalence to predicate devices based on non-clinical testing and general device characteristics rather than a clinical study with detailed acceptance criteria for performance.
Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of device performance against clinical metrics (like accuracy, sensitivity, specificity, or improvement in human reader performance) is not available in this document.
This document specifically states: "The Project E Beauty LED Light Therapy Mask has been evaluated the safety and performance by lab bench testing and conforms to the following international consensus standards." This indicates that the safety and performance evaluation was based on engineering and safety standards, rather than a clinical trial measuring treatment efficacy.
The relevant sections of the document are primarily focused on:
- Indications for Use: Treatment of full face wrinkles and mild to moderate acne.
- Device Description: A facemask using LEDs for red, blue, and infrared light.
- Substantial Equivalence: Comparison of technical parameters (wavelengths, energy levels, treatment time, etc.) to two predicate devices (Neutrogena Light Therapy Aging Mask+ and Neutrogena Light Therapy Acne Mask+).
- Non-clinical Testing: Conformance to electrical safety, EMC, photobiological safety, and biocompatibility standards.
Based on the provided text, a table of acceptance criteria for clinical performance and a study proving the device meets those clinical performance criteria cannot be constructed. The document does not describe a clinical study measuring the direct efficacy of the device on wrinkles or acne in a population, nor does it define acceptance criteria for such efficacy in terms of statistical outcomes or clinical improvement.
To address the specific points of your request based on the absence of this information in the provided text:
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A table of acceptance criteria and the reported device performance:
- Acceptance Criteria (for clinical performance): Not defined in this document. The acceptance criteria mentioned are related to safety and engineering standards (e.g., passing IEC 60601-1 for electrical safety).
- Reported Device Performance (for clinical efficacy): Not reported in this document. The "performance" discussed is in terms of meeting regulatory safety standards and physical characteristics, not clinical outcomes.
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Sample sizes used for the test set and the data provenance: Not applicable. No clinical test set data is presented.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test set and ground truth establishment is described.
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Adjudication method for the test set: Not applicable.
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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 is not an AI-assisted diagnostic device, and no MRMC study is mentioned.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a light therapy device, not an algorithm.
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The type of ground truth used: Not applicable for clinical efficacy. For safety testing, the "ground truth" would be the specifications of the standards themselves.
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The sample size for the training set: Not applicable. No training set is mentioned as it's not an AI/machine learning device.
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How the ground truth for the training set was established: Not applicable.
In summary, the provided FDA 510(k) document (K214101) for the Project E Beauty LED Light Therapy Mask details non-clinical testing to demonstrate safety and substantial equivalence to legally marketed predicate devices, rather than a clinical study with performance acceptance criteria for patient outcomes like wrinkle reduction or acne treatment. The device's approval appears to be based on its similarity to previously cleared devices and its conformance to established safety and electrical 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.