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The CryoGlow LED mask emits energy in the red and infrared light spectrum for the lines and wrinkles and in the red, blue, and infrared light spectrum for the treatment of mild-to-moderate inflammatory acne.

The CryoGlow mask is an over-the-counter (OTC) beauty device intended to emit energy in the red and infrared spectrum to treat fine lines and wrinkles, and in the red, blue, and infrared light spectrum to treat mild-to-moderate inflammatory acne. It is made of molded plastic and is designed to be worn over the face. The device incorporates 480 LEDs (160 tri-wick packages) that emit combinations of red, blue, and infrared light depending on the skin routine chosen. The mask also incorporates under-eye cooling technology. Using the attached remote controller and graphical user interface, users may choose from three skin care routines: Better Aging (red and infrared light), Skin Clearing (blue, red and infrared light), and Skin Sustain (blue and red light). During each routine, a combination of red, blue, and infrared light is emitted for a prescribed amount of time.

The CryoGlow mask also incorporates an under-eye cooling function. Peltiers and fans are used to cool the built-in chill pads (cool sinks) that rest on the surface of the skin under the eyes. The cooling feature turns on automatically with each skin routine, but users may turn off the undereye cooling function during a skin care routine or run a stand-alone under-eye cooling session. The cooling function is intended to refresh/invigorate/soothe the skin. Optional clip-on chill pads are provided with the device to help achieve the proper fit.

Silicone eye shields are built into the design of the mask to help protect the user's eyes from the LED light during a treatment routine. Other built-in safety features include an automatic shut off and auto-dimming feature where the LED lights dim when the mask is away from the user's face. Electrical, mechanical, optical, and thermal safety testing has been conducted to support the safety and effectiveness of the mask.

The CryoGlow mask must be charged prior to use and is provided with a USB-A to USB-C charging cord and USB-A charging block. An optional charging stand is provided separately.

Based on the provided text, the device in question, CryoGlow, is an LED mask that emits light in the red, blue, and infrared spectrum for the treatment of fine lines and wrinkles and mild-to-moderate inflammatory acne. The submission is a 510(k) premarket notification, which establishes substantial equivalence to a legally marketed predicate device (TheraFace, K230293) and a reference device (MZ Skin LightMAX Supercharged LED Mask 2.0, K213184), rather than proving the device meets specific acceptance criteria through an independent clinical study that establishes de novo performance.

However, the document does describe how the CryoGlow device's performance was compared to its predicate device to demonstrate substantial equivalence, which implicitly serves as the "acceptance criteria" for this 510(k) submission.

Here's an analysis of the provided information concerning "acceptance criteria" and the "study that proves the device meets the acceptance criteria" in the context of a 510(k):

Acceptance Criteria and Reported Device Performance (Implicit from Substantial Equivalence Comparison)

Since this is a 510(k) submission, the "acceptance criteria" is primarily the demonstration of substantial equivalence to a predicate device. This means showing that the new device is as safe and effective as a legally marketed device. The performance comparison between CryoGlow and its predicate/reference devices forms the basis of meeting this "acceptance criterion."

Here's an interpretation of the performance comparisons presented in the document, framed as "acceptance criteria" (implicitly similar to predicate/reference) and "reported performance."

Study Details Proving Device Meets Acceptance Criteria:

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

   • The document describes non-clinical bench testing and a human factors/usability study. It does not specify a "test set" in the context of clinical accuracy data (e.g., as in an AI/imaging device).
   • For the bench testing validating optical parameters (power density, total dose, wavelength, light distribution), the sample size would typically refer to the number of devices tested, but this is not explicitly stated. The provenance is internal company testing ("Bench testing was conducted...").
   • For the human factors/usability study, the sample size (number of participants) is not mentioned. Data provenance would be prospective, likely in a simulated or real-world use environment.
   • No clinical efficacy data (e.g., improvement in wrinkles, reduction in acne lesions on human subjects) is provided or referenced, as it is a 510(k) based on substantial equivalence, relying on the predicate device's established efficacy.

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

   • This question is not applicable in the context of this 510(k) submission. There is no mention of an expert-adjudicated ground truth for a clinical test set to evaluate efficacy, as the submission relies on substantial equivalence to a predicate device for its indications for use.
   • The "experts" involved would be the engineers and scientists conducting the non-clinical bench tests and human factors specialists conducting the usability study, following recognized standards.

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

   • Not applicable. There is no clinical imaging or diagnostic test set requiring expert adjudication.

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:

   • Not applicable. This device is an LED therapy mask, not an AI-assisted diagnostic imaging device.

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

   • Not applicable. This is a hardware device; it's not a standalone algorithm in the sense of AI. Its "performance" is its ability to emit light at specific parameters and be used safely and effectively by a human.

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

   • For the technical parameters, the "ground truth" is established by measurement against engineering specifications and applicable international standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 62471, ISO 10993 series). This is objective measurement data.
   • For human factors, the "ground truth" is ensuring the device can be safely and effectively used by lay users as per the study design and FDA guidance. This involves observing user interaction and identifying potential use errors.
   • For efficacy, the "ground truth" for the claims (wrinkle reduction, acne treatment) is implicitly the prior clearance of the predicate device based on its own clinical evidence. The CryoGlow device demonstrates equivalent energy delivery parameters, thus inferring equivalent efficacy.

7. The sample size for the training set:

   • Not applicable. This device is not an AI/machine learning algorithm that requires a "training set" of data.

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

   • Not applicable. As above, no AI-related training set is involved.

Summary of the Study per the Document for 510(k) Clearance:

The "study" in this context refers to a series of non-clinical tests and a Human Factors/Usability study designed to demonstrate that the CryoGlow device is substantially equivalent to existing predicate devices.

• Type of Study: Non-clinical bench testing and a human factors/usability study. No clinical efficacy trials were performed.
• Purpose: To demonstrate substantial equivalence to the predicate TheraFace device and reference MZ Skin LightMAX device, by showing that differences do not raise new questions of safety or effectiveness.
• Key Findings:
  • Optical parameters (wavelength, power/power density, total dose per mode) are either the same or engineered to deliver equivalent therapeutic effects compared to the predicate, accounting for differences in LED count and treatment times.
  • Safety (electrical, photobiological, EMC, biocompatibility) is confirmed by compliance with recognized international standards (IEC 60601 series, IEC 62471, ISO 10993 series).
  • Human factors study confirmed safe and effective use by intended users.
• Ground Truth for Non-Clinical Tests: Objective measurements against engineering specifications and compliance with established international safety and performance standards.
• Ground Truth for Human Factors: Observation and analysis of user interaction to identify and mitigate potential use errors, confirming the device can be used safely and effectively by lay users.

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