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The Photodynamic Therapy Device combination of Red (633nm=10mm) and Blue (417nm=10mm) is intended to emit energy in the red, blue regions of the spectrum to treat dermatological conditions, specifically indicated to treat mild to moderate acne vulgaris.

The Photodynamic Therapy Device KN-7000A is a portable device which uses specific wavelengths of light, produced by light emitting diodes (LEDs), to manage aesthetic conditions. The device produces light in the red light region of the light spectrum (633±10mm) and/or in the blue light region of the light spectrum (417±10nm), intended to help reduce the appearance of mild to moderate acne. There are three irradiators available, Blue LED, Red LED and Blue/Red LED. This device is mainly made up of the main frame, the irradiator, and the lifting stand.

I am sorry but the provided documents do not contain the details necessary to complete the request. The document is a 510(k) premarket notification for a Photodynamic Therapy Device, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study results with acceptance criteria.

Specifically, the following information is missing:

• Acceptance Criteria and Reported Device Performance Table: While the document mentions "performance effectiveness" and "performance safety," it does not list specific acceptance criteria or quantitative performance metrics.
• Sample size for the test set and data provenance: No information is provided about a specific "test set" or its size, country of origin, or whether it was retrospective or prospective.
• Number of experts used to establish ground truth and their qualifications: The document does not describe any human-established ground truth for a test set.
• Adjudication method: No adjudication method is mentioned.
• Multi-reader multi-case (MRMC) comparative effectiveness study: There is no mention of an MRMC study or any effect size for human readers with and without AI assistance.
• Standalone (algorithm-only) performance: The document describes a "Photodynamic Therapy Device," which is a light-emitting device, not an algorithm. Therefore, standalone algorithm performance is not applicable or discussed.
• Type of ground truth used: Since no test set or ground truth establishment is described, this information is not available.
• Sample size for the training set: There is no mention of a "training set" as the device is not an AI/ML algorithm.
• How the ground truth for the training set was established: Not applicable, as there is no training set described.

The document primarily focuses on:

• Comparing the specifications of the proposed device (Photodynamic Therapy Device KN-7000A) to a predicate device (Aklarus Phototherapy System) to establish substantial equivalence.
• Listing compliance with general medical device standards (e.g., IEC 60601 series).
• Mentioning a thermal performance test on human volunteers to ensure skin temperature remains below 41 degrees C.
• Software verification activities.

It does not present a clinical study with detailed acceptance criteria and performance results in the context of an AI/ML device typically associated with such a request.

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