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The Nanolite Skin Care System is indicated to treat pigmented lesions.

The Nanolite Skin Care System is a light-based device that uses LED to stimulate and regenerate skin cells. The device delivers red light at 640 nm.

The principal parts of the device are: the base that contains the power supply; a LED module containing surface mount device chip LEDs; one arm attached to the LED module to be positioned for patient treatment; and a control unit consisting of an LCD panel with a touchscreen display.

The provided text is a 510(k) Summary for the Nanolite Skin Care System and a letter from the FDA regarding its substantial equivalence. It describes the device, its intended use, and its similarities to a predicate device. However, this document does not contain information about a study that proves the device meets specific acceptance criteria.

The 510(k) pathway is primarily focused on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring new clinical trials to prove efficacy or meet specific performance criteria against pre-defined metrics. The document states that "Although there are some differences in the technological characteristics of the Nanolite Skin Care System and its predicate devices, those differences do not raise new questions of safety or efficacy." This implies that new studies demonstrating performance against acceptance criteria were not deemed necessary for this submission.

Therefore, I cannot populate the requested table and answer the study-related questions based on the provided text. The document does not describe acceptance criteria, a study, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or how ground truth was established for training or testing sets.

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