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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.

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KFB290, KFB291:
Red light: Treatment of full-face wrinkles.
Infrared light: Provide topical heating for the purpose of elevating tissue temperature; arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation.
Red+Infrared Light: Treatment of full-face wrinkles.
Amber light: Treatment of full-face wrinkles.
Blue light: Treatment of mild to moderate inflammatory acne.
Mixed light(Red+Blue +Infrared): Treatment of mild to moderate inflammatory acne.

KFB265, KFB293:
Red+Infrared Light: Treatment of wrinkles.
Blue light: Treatment of mild to moderate inflammatory acne.
Amber light: Treatment of wrinkles.

KFB290, KFB291:
LED Light Therapy Device(Models: KFB290, KFB291) is a home use wearable LED phototherapy device which can help reduce wrinkles and acne and provide topical heating. LED Light Therapy Device is consisting of main unit(mask), controller, Silicone eye protector, USB charging cable and straps. The LED Light Therapy Device have 4 kinds of light, which include Red light (wavelength 635nm ± 5mm), Blue light (wavelength 465 ± 5nm), Infrared light (wavelength 850mm ± 5mm), Amber light (wavelength 605 ± 5nm).

KFB 265, KFB 293:
LED Light Therapy Device(Models: KFB 265, KFB 293) is a home use wearable LED phototherapy device which can help reduce wrinkles and acne and provide topical heating. LED Light Therapy Device is consisting of main unit(mask), controller, USB charging cable and adapter. There are several kinds of light having medical effects: Red + Infrared (wavelength 637nm (±5nm), Blue light (wavelength 465nm), Amber light (wavelength 605±5nm).

This section provides information about the acceptance criteria and the study that proves the device meets those criteria for the LED Light Therapy Device (Models: KFB290, KFB291, KFB265, KFB293).

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document details non-clinical performance data (biocompatibility, electrical safety, eye safety, and software verification/validation) and structural equivalence to predicate devices, rather than specific quantitative acceptance criteria for therapeutic efficacy tied to a clinical study. The device is cleared based on demonstrating substantial equivalence to predicate devices, implying that its performance is comparable and acceptable for the stated indications.

The acceptance criteria here are implicitly met by demonstrating compliance with recognized standards and similarity to legally marketed devices.

• IEC 60601-1:2005+A1:2012+A2:2020 (General requirements for basic safety and essential performance)
• IEC 60601-1-2:2014+A1:2020 (Electromagnetic disturbances)
• IEC 60601-1-11:2015+A1:2020 (Home healthcare environment)
• IEC 60601-2-83:2019+A1:2022 (Home light therapy equipment)
• IEC 60601-2-57:2011 (Non-laser light source equipment for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use)
• IEC 62133-2:2017 (Secondary cells and batteries safety) |
  | Eye Safety | Compliance with IEC 62471:2006 (Photobiological safety of lamps and lamp systems). |
  | Software Verification and Validation | Consistent with a moderate level of concern. System validation testing demonstrated that all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels. |
  | Technological Characteristics and Intended Use | Demonstrated to have the same intended use and similar technological characteristics, features, specifications, and materials as legally marketed predicate devices (K223544, K230351, K162489, K221151). Minor differences do not raise safety or efficacy issues. |

2. Sample Size Used for the Test Set and Data Provenance:

The provided document describes non-clinical performance data and a comparison to predicate devices, not clinical studies with human test sets. Therefore, details regarding sample size for a test set and data provenance (country of origin, retrospective/prospective) are not applicable in this context. The evaluation relies on standardized testing (e.g., ISO, IEC) and technical comparisons.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:

This information is not applicable as the submission focuses on non-clinical performance and substantial equivalence based on technical comparisons and compliance with recognized standards, rather than a clinical study requiring expert-established ground truth for a test set.

4. Adjudication Method for the Test Set:

This information is not applicable for the same reasons as point 3.

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:

An MRMC comparative effectiveness study was not conducted or described in the provided document. The device is an LED Light Therapy Device, not an AI-assisted diagnostic or interpretable imaging device for human readers.

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

A "standalone" performance evaluation in the context of an algorithm or AI was not performed or described. This device is a direct-use LED therapy device.

7. The Type of Ground Truth Used:

The "ground truth" for this submission is based on:

• Compliance with recognized international standards: (e.g., ISO 10993 for biocompatibility, IEC 60601 for electrical and medical device safety, IEC 62471 for photobiological safety).
• Substantial equivalence to legally marketed predicate devices: The predicate devices themselves have established a safety and effectiveness profile for the indications.

There is no mention of expert consensus, pathology, or outcomes data from a clinical trial for establishing ground truth regarding therapeutic efficacy for this submission.

8. The Sample Size for the Training Set:

This information is not applicable as the submission is for a phototherapy device, not an AI/machine learning algorithm requiring a training set.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable for the same reasons as point 8.

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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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