Search Results

Medline's Smoke Evacuation Shroud is a single use, sterile product. Its intended use is as an electrosurgical accessory to attach to a standard cautery pencil. The shroud removes surgical procedures. The product is used inside the sterile field.

Medline's Smoke Evacuation Shroud is a single use, sterile product.

I apologize, but the provided text from the FDA 510(k) clearance letter for the "Medline Smoke Evacuation Shroud" does not contain the information necessary to answer your request about acceptance criteria and a study proving device performance as it relates to AI/machine learning devices.

The document is a standard FDA 510(k) clearance letter for a Class II medical device (a smoke evacuation shroud, which is a physical accessory for electrosurgical pencils) and primarily addresses regulatory compliance and substantial equivalence to predicate devices. It does not discuss:

• Acceptance criteria for an AI/ML algorithm.
• Performance studies involving AI/ML.
• Sample sizes for test or training sets.
• Expert involvement in establishing ground truth.
• Adjudication methods.
• MRMC studies or effect sizes for human readers.
• Stand-alone algorithm performance.
• Types of ground truth.

Therefore, I cannot populate the table or provide any of the requested details based on the given input. This document is not relevant to the kind of AI/ML device performance study you are asking about.

Ask a specific question about this device