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The ClearLight Phototherapy System is intended to provide phototherapeutic light to the body. The ClearLight is generally indicated to treat dermatological conditions. The ClearLight is specifically indicated to treat moderate inflammatory acne vulgaris.

The ClearLight Therapy System is a high intensity lamp intended for the therapy of dermatological disorders such as acne vulgaris by emitting visible light in the violet-blue range with fluency of light ranging between 50-200 mW/cm². The system includes a spectral band light source with spectral emittance concentrated in the violet/blue spectral band and an optical system for controlling spectra and beam parameters of the light source. It also includes a 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, and power of the emitted radiation and to capture and store patient data via a touch screen (i.e., control console), and a camera for capturing digital images.

Here's an analysis of the provided text to extract information about acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the provided document, there are no explicitly stated numerical acceptance criteria or quantitative performance metrics for the ClearLight Phototherapy device. The substantial equivalence determination is made against predicate devices, which suggests that the "acceptance criteria" here are qualitative and focused on safety and effectiveness being similar to already marketed devices for the stated indication.

However, we can infer the primary performance goal: Demonstrate safety and effectiveness for treating moderate inflammatory acne vulgaris.

• Clinical data: "Clinical data from the trial of the ClearLight device for the treatment of dermatological conditions supports substantial equivalence and demonstrates that the ClearLight device is safe and effective for the treatment of acne vulgaris." |
  | Substantial Equivalence: Comparable to predicate devices in intended use, indications for use, and technological characteristics without raising new safety/efficacy questions. | Stated to be substantially equivalent to listed predicate devices (Phototherapeutix, Derma-Wand, XTrac Excimer Laser System, Wallaby 3 Phototherapy System) based on similar intended use, general indications, and principles of operation. Differences in technological characteristics "do not raise new questions of safety or efficacy." |

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

• Sample Size for the Test Set: Not mentioned. The document only references "Clinical data from the trial of the ClearLight device." The specific number of patients or cases in this clinical trial is not provided.
• Data Provenance: Not explicitly stated, but the submitter (CureLight Ltd.) is located in Or Akiva, Israel. The study likely originated from Israel, but this is an assumption. The document does not specify if it was retrospective or prospective.

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

• Number of Experts: Not mentioned.
• Qualifications of Experts: Not mentioned.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not mentioned.

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:

• MRMC Study: No, this is not an AI-assisted diagnostic device, but rather a phototherapy system. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not conducted.

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

• Standalone Performance: Not applicable. This is a phototherapy device, not an algorithm. The "performance" refers to its physical therapeutic effects rather than algorithmic output.

7. The Type of Ground Truth Used:

• Ground Truth: The document states that "Clinical data from the trial... demonstrates that the ClearLight device is safe and effective for the treatment of acne vulgaris." This implies that the ground truth for effectiveness was likely based on clinical outcomes observed in patients (e.g., reduction in lesion count, physician global assessment of acne severity, or patient-reported outcomes for acne treatment). The "in vitro testing" provided biological evidence (eradication of P. acnes) which supports the mechanism of action but isn't the primary clinical ground truth.

8. The Sample Size for the Training Set:

• Sample Size for Training Set: Not applicable. This is not a machine learning device that requires a training set in the conventional sense. The "training" here would be the development and testing of the physical phototherapy system itself (e.g., optimizing light parameters), rather than training an algorithm on a dataset.

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

• How Ground Truth for Training Set Was Established: Not applicable, as it's not an AI/ML device requiring a training set with established ground truth.

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