FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

Silicon flexible face mask
Controller
Power supply and country specific adaptors
USB C to USB A connector
Head straps
faceLite is a home use wearable LED phototherapy device whose purpose is to produce an even, cool, narrow band of light for the treatment cosmetic indications including facial wrinkles.
The system consists of a flexible silicon mask that contains light emitting diodes (LEDs) and a controller. The LEDs generate the light. The mask is worn on the face and is held in place by an adjustable Velcro strap. The mask compromises of 2 surfaces. An inner surface that contacts the skin and an outer surface. Both surfaces are constructed of the same silicone (Methyl vinyl silicone rubber, Genvan GA 3 series GA9 series).
The inner surface contacts with the user's skin. Contact is restricted to normal intact skin and only for a duration of 10 minutes (treatment time). Methyl vinyl silicone rubber GENVAN GA 3 series GA9 series has been tested to those tests specified under ISO 10993-5:2009 tests for in vitro cytotoxicity and ISO10993-10:2010 Tests for irritation and skin sensitization
The controller (Polycarbonate PC1100) switches the LEDs ON/OFF and controls power to the mask. The controller contains a rechargeable Lithium ion polymer battery. The controller uses a visible display comprising of 3 micro LEDs to show the user the battery charge status of the device.
The power supply (SK01T-0500100Z) is used to charge the Lithium battery and is connected to a suitable mains outlet via a 2 or 3 pin input socket and wall plug. The power cable is connected to the controller by a standard micro USB A-C connector. The faceLite cannot be operated while charging.
The equipment is not used to make measurements of any sort, or to draw any conclusions regarding the indication to treat. The equipment does not require checks on the light output as the LEDs do not dim with age to any practical extent.
The faceLite Light emitting diode (LED) system emits light energy in the red and near infrared (NIR) region of the light spectrum and is intended to treat facial wrinkles through a nonthermal mechanism called Photobiomodulation.

AI/ML Overview

The provided document, a 510(k) Premarket Notification summary for the faceLITE LED mask, focuses on demonstrating substantial equivalence to a predicate device (LG BEAUTY LED MASK K170984) rather than presenting a standalone study with acceptance criteria for device performance in treating wrinkles.

Therefore, the information required to fully answer the request (acceptance criteria, details of a study proving performance, sample sizes, expert involvement, ground truth establishment, etc.) is not present in the provided text for the device's efficacy in treating wrinkles.

The document primarily discusses:

Regulatory classification and product codes.
Device description and intended use.
Comparison to a predicate device (LG Beauty LED Mask) to establish substantial equivalence.
Non-clinical performance testing: This section details compliance with various electrical safety, usability, photobiological safety, biocompatibility, and software standards. It also mentions a "label comprehension testing" study.
Statement on clinical performance: Explicitly states that "clinical data is not required" because the device "raises no new questions in terms of safety and efficacy" compared to the predicate.

Given this, I can only address parts of your request based on the provided text, particularly the label comprehension study, which is a non-clinical performance testing, but not related to the device's efficacy for its intended use (full-face wrinkles).

Here's a breakdown of what can and cannot be extracted from the document regarding your specific points:

1. A table of acceptance criteria and the reported device performance

For efficacy in treating wrinkles: Not provided. The document states clinical data is not required because it's substantially equivalent. There are no performance metrics or acceptance criteria for wrinkle reduction mentioned.
For Label Comprehension Testing (non-clinical performance):
- Acceptance Criteria for Label Comprehension: Not explicitly stated as a numerical threshold (e.g., "X% of participants must correctly answer Y questions"). The study "demonstrated that the faceLITE labelling could be used by lay persons to safely and effectively operate the device to attain its intended use and purpose." This implies a qualitative or implicitly quantitative acceptance, but the specific target is not given.
- Reported Device Performance (Label Comprehension): The study "demonstrated that the faceLITE labelling could be used by lay persons to safely and effectively operate the device to attain its intended use and purpose." No specific quantitative performance (e.g., average score, pass rate) is reported beyond this qualitative statement.

2. Sample size used for the test set and the data provenance

For efficacy in treating wrinkles: No test set or data provenance for efficacy is described, as clinical data was not deemed necessary.
For Label Comprehension Testing (non-clinical performance):
- Sample Size: 32 subjects.
- Data Provenance: Not explicitly stated (e.g., country of origin). It's a "study" that was "conducted and is appended to this section," suggesting it was prospective research specific to this submission. The submitter is UK-based, so it might be UK data.
- Retrospective/Prospective: Likely prospective, as it was conducted specifically for this submission.

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

For efficacy in treating wrinkles: Not applicable. No such study was performed or described.
For Label Comprehension Testing: "Ground truth" for comprehension tests is typically defined by correct answers to questions based on the labeling. No "experts" external to the product development team would be needed to establish this. The study participants themselves are demonstrating their comprehension against a pre-defined set of correct interpretations of the labeling.

4. Adjudication method for the test set

For efficacy in treating wrinkles: Not applicable.
For Label Comprehension Testing: Not described. For comprehension, it usually involves comparing participant responses to pre-determined correct answers, not expert adjudication in the typical medical imaging sense.

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 for wrinkle treatment, not an AI-assisted diagnostic device where MRMC studies are common. No human readers or AI assistance are mentioned in the context of its intended use.

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

Not applicable. This is a hardware device, not an algorithm.

7. The type of ground truth used

For efficacy in treating wrinkles: Not applicable.
For Label Comprehension Testing: The "ground truth" was the accurate understanding and safe operation of the device as intended by the manufacturer, based on the provided labeling and instructions.

8. The sample size for the training set

For efficacy in treating wrinkles: Not applicable. No training set for efficacy is mentioned. The device is not learning or adapting.
For Label Comprehension Testing: Not applicable. This was a test of label comprehension by human users, not an algorithm being trained.

9. How the ground truth for the training set was established

Not applicable.

In summary, the provided document does not contain the information you requested regarding the acceptance criteria and study proving the device's efficacy in treating wrinkles, as it relied on substantial equivalence rather than new clinical data for this purpose. The only "performance" study mentioned is a non-clinical label comprehension test.

Summary

Regulation Number and Section

§ 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.