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The Powerlite 600® EP System is used for the removal of unwanted hair.

The Powerlite 600® EP System delivers pulsed light at a wavelength beginning at a wavelength of 600nm. The device consists of three interconnected sections: the system console which houses the internal cooling system, power supply and micro-controller, the handle hose to the handpiece, and the handpiece, which houses the wavequide.

The provided text is a 510(k) summary for the Powerlite 600® EP System. It does not contain details about acceptance criteria, device performance, clinical studies showing the device meets acceptance criteria, or ground truth establishment.

The document explicitly states:

• "8. Discussion of Clinical Tests Performed: Non-Applicable"

This indicates that the submission did not rely on clinical trials to demonstrate substantial equivalence. Instead, it focused on the device's technical similarity and intended use compared to a predicate device.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth from the provided text. The document's purpose is to establish substantial equivalence based on non-clinical aspects and comparison to a predicate device, not to report on clinical performance against specific acceptance criteria.

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