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• · Red Light is intended to treat full face wrinkles
• · Blue Light is intended to treat mild to moderate inflammatory acne
• · Red + Infrared Light is intended to treat full face wrinkles

The TheraFace Mask device is a lightweight device which uses specified wavelengths of LED light. For LED light irradiation function, the device produces light in the red-light region of the spectrum (633±10nm), combination of IR and Red light (830nm±10nm & 633 ± 10 nm), or in the blue light region of the spectrum (415±10nm).

The TheraFace Mask device is shaped like a human face and is designed to be "one size fits most." There are two physical buttons located on the mask; one controls the LED function and the other controls the vibration. The 648 LEDs in the device are powered by two internal lithium-ion rechargeable batteries which are charged via USB Type C or A cable with power adaptor.

Red light mode: In Red light irradiation mode, the device utilizes Light Emitting Diodes to emit The output is one wavelength with a narrow spectral bandwidth in 633±10nm. red light. lt provides narrow bands of red-light energy to facial skin and is intended to treat full-face wrinkles.

Blue light mode: In blue light irradiation mode, the device utilizes Light Emitting Diodes to emit blue light. The output is one wavelength with a narrow spectral bandwidth in 415±10nm. It provides narrow bands of blue light energy to facial skin and is intended to treat mild to moderate inflammatory acne.

Red+ IR mode: When the device is operated in the red combined with infrared light mode, it emits LED light in the RED (633 nm±10nm) and IR (830 nm±10nm) spectrum on facial skin. lt is intended to treat full face wrinkles.

Vibration mode: The device can drive 8 vibration motors around the eyes and 9 vibration motors on the top and back of the head in different vibration speeds. There are 3 different vibration patterns; continuous mode, breathe mode, and wave mode. Vibration is included for general relaxation purposes.

The provided text is a 510(k) summary for the TheraFace Mask, demonstrating its substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria through clinical performance. Therefore, most of the requested information regarding acceptance criteria and a "study that proves the device meets the acceptance criteria" (in the sense of a clinical performance study with defined endpoints/metrics) is not present in this document.

The document focuses on comparing the proposed device's technical specifications and safety characteristics to those of legally marketed predicate devices to establish substantial equivalence, as is typical for a 510(k) submission where no clinical studies were performed.

Here's a breakdown based on the provided text:

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

The document does not present "acceptance criteria" in the format of specific performance thresholds for clinical outcomes (e.g., "X% reduction in wrinkles," "Y% clearance of acne") that the device's performance was measured against. Instead, it demonstrates compliance with recognized device safety and performance standards, and substantial equivalence to predicates.

The "Performance Comparison" table (Table 2) lists technical specifications. While not acceptance criteria in the clinical sense, these represent the device's measured performance in terms of light output.

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

The document explicitly states: "(9) PERFORMANCE TESTING CLINICAL: There were no clinical studies performed."

The testing mentioned relates to bench testing (e.g., light power density, usability, temperature, cleaning, disinfection) and compliance with recognized standards for electrical safety, photobiological safety, EMC, and biocompatibility. These tests do not involve human subjects or a "test set" sample size in the clinical sense.

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

Not applicable, as no clinical studies with a ground truth established by experts were performed.

4. Adjudication method for the test set

Not applicable, as no clinical studies with a ground truth and adjudication were performed.

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. The device is a direct-to-consumer LED mask, not an AI-assisted diagnostic device requiring MRMC studies.

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

Not applicable. The device is not an algorithm, but a physical LED light therapy mask.

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

Not applicable, as no clinical studies requiring a ground truth were performed. The "ground truth" for the device's performance is established by its engineering specifications and compliance with safety standards, not clinical outcomes.

8. The sample size for the training set

Not applicable, as no AI/machine learning component requiring a training set is mentioned.

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

Not applicable, as no AI/machine learning component requiring a training set is mentioned.

Summary of what the document does prove:

The document focuses on demonstrating substantial equivalence to existing legally marketed devices based on:

• Same Indications for Use: Treat full face wrinkles (Red Light, Red + Infrared Light) and mild to moderate inflammatory acne (Blue Light).
• Similar Technological Characteristics: Utilizes LED light at specific wavelengths, powered by internal batteries, and designed for at-home use. Differences (e.g., exact power density, treatment duration, inclusion of vibration) are justified as not affecting safety or effectiveness.
• Compliance with Recognized Standards: The device has undergone extensive bench testing and successfully complies with international standards for electrical safety (IEC 60601-1, -1-11, -1-2, -2-57), photobiological safety (IEC 62471), and biocompatibility (ISO 10993 series). This demonstrates its safety profile.

In essence, the "study that proves the device meets the acceptance criteria" in this context is the comprehensive set of bench tests and compliance reports that show the device functions as intended from an engineering and safety perspective, and is comparable to predicate devices already cleared for market. There is no clinical performance study presented in this document.

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