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The Skin Care Beauty Mask (Model: MJ-06) emits energy in the red and blue region of the spectrum, specifically indicated to treat full face wrinkles and/or mild to moderate acne.

The Skin Care Beauty Mask (Model: MJ-06) is a facemask-shaped device, which makes use of specific light spectral characteristics and directly applies light onto the face skin surface. The Skin Care Beauty Mask can emit two different kinds of wavelengths. The blue light (465nm) is intended to help reduce the appearance of mild to moderate inflammatory acne. Red light (640nm) is intended to improve the appearance of wrinkles. There are 150 LED lights with a center wavelength of 465nm and 150 LED lights with a center wavelength of 640nm, and the energy provided by each mode is 30mw/cm2 . The user wears the mask on their face for the treatment, and the device will shut down automatically after finishing a 5-minute treatment or 10-minute treatment selected.

The provided text is a 510(k) Summary for the Skin Care Beauty Mask (Model: MJ-06), which is a premarket notification to the FDA for demonstrating substantial equivalence to a legally marketed predicate device. This document focuses on demonstrating that the new device is as safe and effective as existing products, rather than proving a novel clinical benefit through extensive clinical studies with acceptance criteria and statistical analysis.

Therefore, the requested information regarding detailed acceptance criteria, specific study designs (like MRMC or standalone performance), sample sizes for test and training sets, expert qualifications, and ground truth establishment, is largely not present within this type of regulatory submission.

The "Test Summary" section primarily refers to bench testing against recognized safety and performance standards, not clinical trials to measure effectiveness against specific numerical acceptance criteria for clinical outcomes. The FDA clearance is based on substantial equivalence to a predicate device (K202390), indicating that its technological characteristics and intended use are similar enough not to raise new questions of safety or effectiveness.

Here's a breakdown of what can be extracted and what is missing, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable in the typical sense of clinical performance acceptance criteria. The "acceptance criteria" here are compliance with recognized electrical safety, EMC, and biocompatibility standards, and demonstrating substantial equivalence to a predicate device in terms of design, function, and intended use. The table below reflects the comparison to the predicate device and the standards met.

2. Sample Size for the Test Set and Data Provenance

• Sample Size for Test Set: Not mentioned. The document primarily refers to "lab bench testing" (Section 6) against recognized standards and a comparison to a predicate device. There is no indication of a clinical "test set" with human subjects specifically for evaluating the effectiveness of the MJ-06 model in a clinical trial setting to establish new performance claims.
• Data Provenance: The document does not specify country of origin for any clinical data because detailed clinical performance data in a trial setting is not provided. It mentions the manufacturer as Shenzhen Kaiyan Medical Co Ltd, China, and a distributor in Denver, CO, USA. The "Test Summary" only lists engineering and biocompatibility standards.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not applicable. This information would be relevant for clinical studies where expert consensus or diagnostic interpretation is needed to establish ground truth for a test set. This document relies on compliance with engineering standards and comparison to a previously cleared device.

4. Adjudication Method for the Test Set

• Not applicable. As no clinical test set requiring expert adjudication is described, this information is not present.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No. An MRMC study is a type of clinical study assessing diagnostic performance, usually comparing human readers with and without AI assistance. This document is a 510(k) submission for a physical light therapy device, not a diagnostic AI algorithm, and does not mention any such study.

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

• Not applicable. This device is a physical light therapy mask, not an algorithm.

7. The Type of Ground Truth Used

• For the technical and biocompatibility testing, the "ground truth" is compliance with the specified international standards (e.g., IEC 60601 series for electrical safety, ISO 10993 series for biocompatibility).
• For the overarching claim of effectiveness, the "ground truth" is established by the predicate device's prior clearance by the FDA for similar indications. The current device demonstrates substantial equivalence to this predicate.

8. The Sample Size for the Training Set

• Not applicable. This information is relevant for AI/machine learning models. The device is a hardware light therapy system.

9. How the Ground Truth for the Training Set was Established

• Not applicable.

In summary: The provided 510(k) summary is a regulatory document focused on demonstrating equivalency to a predicate device and adherence to safety standards. It does not contain the detailed clinical study data typically associated with a novel device proving its effectiveness against specific clinical acceptance criteria. The FDA's clearance (K220168) is based on the argument that the device is "substantially equivalent" to an already approved device (K202390) and meets relevant safety standards, meaning it does not raise new questions of safety or effectiveness.

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The Skin Care system is intended for aesthetic anplications and for selective treatments required by medical dermatology specialties.

The skin care system and optional Hand pieces with 420 - 1050 nm wavelengths, with and without contact cooling, is indicated for, but not limited to:

• Hair removal and Permanent Hair Reduction in all skin types (1-VI) to the Fitzpatrick scale

• Recommended wavelengths in the range of 670-1050 nm, 755-950 nm or 580-1050 nm

• Treatment of Pigmented and Vascular Lesions in all skin types (I-VI) to the Fitzpatrick scale

• Recommended wavelength in the range of 515-950 nm

• Treatment of Inflammatory Acne (acne vulgaris) in skin types (I-V) to the Fitzpatrick scale

• Recommended wavelength in the range of 420-950 nm

• Treatment of Benign Pigmented Epidermal and Cutaneous Lesions including warts, scars and striae in all skin types (1-VI) to the Fitzpatrick scale

• Recommended wavelength in the range of 560-950 nm

Permanent hair reduction is defined as the long-term stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen.

Not Found

I am sorry, but the provided text from the FDA 510(k) K152736 document for the "Skin Care" device does not contain the specific information required to answer your request.

The document is primarily a substantial equivalence determination letter, outlining the device's classification, regulatory requirements, and indications for use. It lacks details about:

• Acceptance criteria for device performance.
• Specific studies proving the device meets acceptance criteria.
• Sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or ground truth details for any testing.
• Training set information.

Instead, it refers to the device being substantially equivalent to legally marketed predicate devices, which means its safety and effectiveness are deemed similar to devices already on the market, rather than requiring new, detailed performance studies for this particular 510(k) submission to establish new benchmarks.

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Skin Care Light is intended to provide phototherapeutic light to the face. It is used to treat dermatological conditions by exposing the surface of the skin to the blue spectrum. It is specifically indicated to treat moderate inflammatory acne vulgaris.

Skin Care Light is a lamp intended to treat dermatological conditions by emitting visible light in blue and/or red.The energy intensity are 4,8,12mW/c m².The system includes a spectral band light source and some controlling keys to select light.It also includes mechanical fixture for holding the light source at an adjustable distance and direction related to the skin treatment area,an electronic unit to control the duration,it will automatically shut off after 15 minutes.

The provided text is a 510(k) summary for the "Skin Care Light" device. It outlines the device's classification, intended use, and a statement of substantial equivalence to a predicate device. However, this document does not contain explicit acceptance criteria or a detailed study proving the device meets specific performance criteria.

The 510(k) process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials or performance studies with predefined acceptance criteria for novel claims. The provided text indicates the device is substantially equivalent to the "ClearLight Phototherapy Device, Model CL 420 (K013623)". The FDA's letter (pages 3-4) confirms this determination based on the information submitted.

Therefore, many of the requested details about acceptance criteria, study sample sizes, expert involvement, and ground truth establishment are not present in this kind of 510(k) summary document for substantial equivalence.

Here's a breakdown of what can be extracted and what cannot:

1. Table of acceptance criteria and reported device performance:

• Acceptance Criteria: Not explicitly stated in terms of performance metrics for the "Skin Care Light" device itself. The primary "acceptance criterion" for the 510(k) submission was demonstrating substantial equivalence to the ClearLight Phototherapy Device.
• Reported Device Performance:

  • Energy Intensity: 4, 8, 12 mW/cm² (for light emitted).

  • Light Spectrum: Visible light in blue and/or red spectrum.

  • Duration Control: Automatically shuts off after 15 minutes.

  • Intended Use: To treat moderate inflammatory acne vulgaris.

    It's important to note that these are device specifications and intended use, not performance metrics against a defined acceptance criterion for efficacy from a specific study within this document.

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

• Not explicitly stated in this document. A 510(k) summary demonstrating substantial equivalence typically references the predicate device's performance data rather than conducting new, large-scale clinical trials for the new device. If a performance study was conducted for the "Skin Care Light," its details are not in this summary.

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

• Not applicable/Not stated in this document. Since no explicit performance study with a 'test set' for the "Skin Care Light" is described, there's no mention of experts establishing ground truth for such a set.

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

• Not applicable/Not stated in this document.

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 a light therapy device, not an AI-assisted diagnostic or imaging device that would typically involve human readers or MRMC studies.

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

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

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

• Not stated for the "Skin Care Light." For substantial equivalence, the "ground truth" implicitly relies on the predicate device's established safety and effectiveness. If the predicate device (ClearLight Phototherapy Device) had clinical studies to support its claims, those would have used some form of ground truth (e.g., clinical assessment by dermatologists, lesion counts, etc.), but this isn't detailed for the "Skin Care Light" itself in this document.

8. The sample size for the training set:

• Not applicable/Not stated. This is not an AI/machine learning device that requires a training set.

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

• Not applicable/Not stated.

In summary: The provided 510(k) summary focuses on demonstrating that "Skin Care Light" is substantially equivalent to a predicate device (ClearLight Phototherapy Device, Model CL 420, K013623) based on its intended use and general technological characteristics. It does not contain the detailed performance study data, acceptance criteria, or ground truth establishment that would be present for a novel device undergoing extensive clinical trials or an AI/machine learning device. The "proof" is the FDA's determination of substantial equivalence, allowing it to be marketed for the stated indications.

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