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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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