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The Er:aser™ laser is intended for coagulation, ablation, vaporization, or cutting of soft tissue in dermatology and plastic surgery, including aesthetic surgery and skin resurfacing.

The Epulse laser is an erbium:YAG laser which emits its energy at 2.94 um.

The provided text is a 510(k) summary for the Epulse Er:aser™ Laser System. It states that performance data was not required because the specifications and intended uses of the Epulse laser are considered "the same or very similar (substantially equivalent)" to legally marketed predicate devices. Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets them.

The relevant section states:

"None. The specifications and intended uses of the Epulse laser are the Performance Data: same or very similar (substantially equivalent) to those of the claimed predicate devices. There are no significant differences between the devices under conditions of intended use. Because of this, performance data were not required."

As such, I cannot populate the table or answer the specific questions about the study, sample sizes, ground truth, or expert involvement, as this information is explicitly stated as "not required" and therefore not provided in the document.

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