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This product is indicated for use in minimally invasive procedures for removing smoke generated by electrocautery and small amount of fluids when used in conjunction with an effective suction equipment.

The smoke evacuator has two parts - the exhaust tube and the control valve. The product can be installed on 5mm surgical electrode/high-energy instrument in minimally invasive surgery. The product is connected with the vacuum suction system, using negative pressure to extract smoke, small amount of blood and water from the tip of the surgical instrument.

This document is a 510(k) clearance letter for a medical device, the "Vigeon" Laparoscopic Universal Smoke Evacuator (VG003). It demonstrates substantial equivalence to predicate devices. For devices cleared through the 510(k) pathway for substantial equivalence, the focus is on showing similarity to existing cleared devices rather than establishing novel clinical effectiveness or "proving" performance against specific acceptance criteria for an AI/software as a medical device (SaMD).

Therefore, this document does not contain the information requested regarding acceptance criteria for an AI/SaMD, nor does it detail a study proving such a device meets these criteria. The "performance testing" mentioned (phantom experiment, suction function, safety distance, operational safety) are typical for a physical medical device to ensure its mechanical and safety properties, not performance metrics for an AI/SaMD.

Here's why the requested information is absent:

• Device Type: The "Vigeon" Laparoscopic Universal Smoke Evacuator (VG003) is a physical, accessory device used in surgery, not an AI or software-as-a-medical-device (SaMD).
• Regulatory Pathway: The 510(k) pathway for substantial equivalence often relies on comparative testing to predicates for physical performance and safety, not on the rigorous statistical validation against ground truth that AI/SaMD products require.
• "Performance Testing" Description: The description of performance testing ("Phantom experiment, performance testing of suction function, safety testing of the safety distance and operational safety testing") clearly indicates physical testing of the device's mechanical and operational functions, not evaluation of an AI algorithm's diagnostic or predictive capabilities.

In summary, as this is a physical medical device (a smoke evacuator) and not an AI/SaMD, the concepts of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the context of an AI algorithm's performance are not applicable to the provided document.

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