Search Results

The LED Facial Mask is an over-the-counter (OTC) device intended for the following uses:

For Red Mode(s): The device emits energy in the red spectrum and is intended for the treatment of full-face wrinkles.

For Red + NIR Mode: The device emits energy in the red and infrared spectrum and is intended for the treatment of full-face wrinkles.

For Blue Mode: The device emits light in the blue region of the spectrum and is specifically indicated for the treatment of mild to moderate acne on the face.

For NIR Mode: The device is intended to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation.

The LED Facial Mask is a device used for treatment of full-face wrinkles, mild to moderate acne on the face, and providing topical heating. LEDs housed inside the device emit light onto the face. These LEDs generate blue, red, and infrared wavelengths.

This product is composed of the main device, controller, fastening straps, storage bag, blindfold, and charging cable.

This FDA 510(k) clearance letter pertains to an LED Facial Mask, which is categorized as a Class II medical device. The information provided outlines the manufacturing, intended use, and comparison to predicate devices, but it does not contain the specific performance data one would expect for a study proving the device meets acceptance criteria.

The document primarily focuses on demonstrating substantial equivalence to already cleared predicate devices based on technological characteristics and intended use. The "Performance Data" section lists various recognized consensus standards to which the device was tested (e.g., electrical safety, electromagnetic compatibility, usability, biological evaluation), rather than clinical study results establishing efficacy.

Therefore, I cannot create the detailed table of acceptance criteria and reported device performance, nor can I answer questions about sample size, ground truth establishment, expert adjudication, or MRMC studies, as this information is not present in the provided FDA clearance letter.

It explicitly states: "Clinical/animal testing was not performed for the proposed device as part of the submission." This confirms the absence of efficacy studies that would typically define acceptance criteria for performance outcomes.

The acceptance criteria for this device, as implied by the FDA 510(k) process for a Class II device, are largely related to safety, performance against engineering standards, and substantial equivalence to legally marketed predicate devices. The clearance is based on the premise that if the new device is sufficiently similar to existing cleared devices in terms of its technology and intended use, and meets relevant safety standards, it does not require new clinical efficacy data.

Here's a breakdown of what can be inferred from the document regarding acceptance criteria and the "study" (non-clinical testing) that proves the device meets them:

Inferred Acceptance Criteria and Device "Performance" (Non-Clinical)

Since no clinical efficacy studies were performed, the "acceptance criteria" are not related to a specific clinical outcome (e.g., X% reduction in wrinkles, Y% clearance of acne). Instead, they relate to safety, electrical performance, and biocompatibility, as demonstrated through testing against consensus standards.

Study Details (Based on the Provided Document)

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not applicable in the context of clinical data for efficacy. The "test set" here refers to the device itself being tested against engineering and safety standards. There is no patient sample size.
   • Data Provenance: The tests conducted are in vitro (bench testing) and in silico (software analysis) or conducted on the physical device itself, not on human subjects. Therefore, there's no country of origin for patient data, nor is it retrospective or prospective clinical data.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. The "ground truth" for the engineering and safety tests is defined by the consensus standards themselves (e.g., a certain voltage tolerance, a specific emission limit). The "experts" would be the engineers and technicians performing the tests and verifying compliance with the standards, not clinical experts establishing ground truth for medical conditions.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable. This concept pertains to clinical studies where human interpretation of medical data needs to be harmonized. For engineering tests, results are typically objective measurements against a standard.

4. 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:

   • No. This type of study is for AI/CADe devices and involves human readers reviewing cases. This device is an LED facial mask, not an AI diagnostic tool.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • No. This applies to AI/CADe devices.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth" for this clearance is adherence to recognized consensus standards for safety, electrical performance, photobiological safety, and biocompatibility, as well as demonstrated technical similarity and intended use alignment with predicate devices. There is no clinical ground truth (e.g., biopsy results, clinician's diagnosis) involved in this substantial equivalence determination.

7. The sample size for the training set:

   • Not applicable. There is no AI model or "training set" for this device.

8. How the ground truth for the training set was established:

   • Not applicable.

In summary, the provided FDA 510(k) clearance document for the LED Facial Mask demonstrates that the device was cleared based on its substantial equivalence to existing devices and its adherence to a series of non-clinical safety and performance standards. No clinical efficacy studies were conducted or required for this particular clearance, as explicitly stated in the document.

Ask a specific question about this device