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The Venus Swan™ is a non-invasive device intended for use in Dermatologic and general surgical procedures for the non-invasive treatment of mild to moderate facial wrinkles and rhytides.

The Venus Swan™ System uses Radiofrequency (RF) energy in (MP)2 technology for treatment. (MP)2 technology is a Multi-Polar array of Bi-Polar RF electrodes. The Venus Swan™ is a modification to the previously cleared Venus Concept's Venus Freeze system (K100586). The Venus Swan™ is a non-invasive system consisting of: - Main Unit (console) - Touch Screen user interface - RF Power module Controller unit Three optional treatment applicators: (1) Octipolar-LTM applicator - for large treatment areas, composed of 8 RF electrodes (2) Octipolar-M™ applicator - for medium sized treatment areas, composed of 8 RF electrodes (3) Diamondpolar™ applicator - for small treatment areas, composed of 4 RF electrodes The system can be connected to two applicators only at a time. The user can choose which applicator to use according to the size of the treatment area. The Touch screen user interface provides: - Applicator selection - RF Power Output and Treatment Time parameter adjustments - Current treatment parameters display. The RF power module provides RF energy to the selected applicator, producing a 1MHz signal.

I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the format requested. The document is a 510(k) summary for the Venus Swan System, which focuses on device description, intended use, and substantial equivalence to a predicate device (Venus Freeze) rather than detailed clinical study results with specific performance metrics and acceptance thresholds.

Therefore, I cannot populate the table or answer the specific questions about sample sizes, expert qualifications, ground truth, or comparative effectiveness studies.

The document primarily states:

• Intended Use: Non-invasive treatment of mild to moderate facial wrinkles and rhytides.
• Performance Standards: Compliance with general electrical and medical device safety standards (EN 60601-1, IEC 60601-1-2, ANSI AAMI 60601-2-2).
• Substantial Equivalence: Claims substantial equivalence to the Venus Freeze (K100586). This typically means that the manufacturer asserts the new device is as safe and effective as a legally marketed predicate device, and often relies on similar technological characteristics and performance rather than new, extensive clinical studies for standalone performance claims against specific clinical acceptance criteria.

To answer your request, a different type of document, such as a full clinical study report, would be needed.

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