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The Surgiform Saf-T-Vac® Smoke and Fluid Evacuator is an add-on device used to provide an air suction path for the reduction of gases, body fluids, and smoke associated with the use of most electro-cauterization systems that are not designed with integrated smoke evacuation capabilities. The Saf-T-Vac® is intended to be used with currently designed and distributed electro-cauterization systems, and most standard operating room suction systems.

The Surgiform Saf-T-Vac® Smoke and Fluid Evacuator is an add-on device used to provide an air suction path for the reduction of gases, body fluids, and smoke associated with the use of most electro-cauterization systems that are not designed with integrated smoke evacuation capabilities.

I am sorry, but based on the provided document, I cannot answer your request. The document is a 510(k) clearance letter from the FDA for a medical device called the "Saf-T-Vac Smoke and Fluid Evacuator." It primarily discusses the regulatory approval process, substantial equivalence, and general controls for the device.

The document does not contain any information regarding:

• Acceptance criteria or reported device performance in a table format.
• Details of any study conducted to prove the device meets acceptance criteria.
• Sample sizes, data provenance, ground truth establishment, expert qualifications, or adjudication methods for any test or training sets.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study or a standalone algorithm performance study was done.
• The type of ground truth used for any studies.

Therefore, I cannot extract the information you requested from the provided text.

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