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Used in conjunction with the electrosurgical pencil of 510(k) Notification K791137, the accessory is intended to remove smoke generated by electrosurgery.

Smoke Evacuation Attachment

Based on the provided documents, it is not possible to describe the acceptance criteria and the study that proves the device meets those criteria.

The documents are a 510(k) premarket notification letter from the FDA to Conmed Corporation regarding a "Smoke Evacuation Attachment." This letter grants specific approval to market the device based on its substantial equivalence to a predicate device.

The information requested in your prompt (acceptance criteria table, sample sizes, ground truth establishment, expert qualifications, MRMC studies, standalone performance, etc.) pertains to clinical performance studies and detailed validation processes that are typically part of a 510(k) submission. However, this particular letter and its associated enclosure only provide the FDA's decision, the device name, and its indications for use. It does not contain any of the underlying data, study designs, or performance metrics from Conmed's submission.

Therefore, I cannot answer any of the questions from your prompt based on the provided text.

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