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The Profile 1320 Laser System is indicated for use in general surgery and dermatology for the incision, excision, ablation, vaporization, coagulation, with hemostasis of soft tissue.

Profile 1320 Laser System is an Nd:YAG laser producing emission at a wavelength of 1320 nm. It consists of a laser console, internal computer, control panel and display, an optical delivery system comprised of an articulated arm and a handpiece or scanner with cooling capability, and a footswitch.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving that the device meets specific acceptance criteria. This document is a 510(k) premarket notification summary for a laser system, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting performance study results against defined acceptance criteria.

The 510(k) summary provided describes:

• Device Trade Name: Profile 1320 Laser System
• Common Name: Nd:YAG Laser System
• Intended Use: "The Profile 1320 Laser System is indicated for use in general surgery and dermatology for the incision, excision, ablation, vaporization, coagulation, with hemostasis of soft tissue."
• Predicate Device: CoolTouch Nd:YAG Laser System (K002347)
• Rationale for Substantial Equivalence: It states the device "shares the same indications for use, similar design features (including wavelength, laser medium, power supply, cooling and control system), functional features (including power output, repetition rate, energy, spot size and fluence), and is therefore substantially equivalent to the above legally marketed predicate device."

This type of submission focuses on comparing the new device to an existing one to show it's "substantially equivalent," meaning it's as safe and effective as the predicate device, and doesn't typically include detailed clinical studies with specific acceptance criteria and performance metrics in the way a PMA (Premarket Approval) or de novo submission might.

Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria, study details, sample sizes, expert involvement, or ground truth, as this information is not present in the provided 510(k) summary.

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