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The SenoRx ES 3000 is an electrosurgical generator which is intended for general surgical procedures where electrosurgical cutting or coagulation of soft tissues is required.

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I am sorry, but based on the provided document, there is no information about acceptance criteria for a device's performance, nor any study proving the device meets said criteria.

The document is a 510(k) clearance letter from the FDA for the "ES 3000 Electrosurgical Generator System." This letter confirms that the device has been found substantially equivalent to a legally marketed predicate device, allowing it to proceed to market.

Here's why the information you're looking for is not present:

• 510(k) clearance primarily focuses on demonstrating substantial equivalence to a predicate device, not necessarily on proving new performance criteria through extensive studies. While performance data may be submitted as part of a 510(k), the letter itself does not detail specific acceptance criteria or study results.
• The document mentions the device name (ES 3000 Electrosurgical Generator System) and its intended indications for use (general surgical procedures where electrosurgical cutting or coagulation of soft tissues is required). These are regulatory classifications and intended uses, not performance metrics or study outcomes.
• The letter refers to general controls provisions of the Act (annual registration, listing, good manufacturing practice, labeling, prohibitions against misbranding and adulteration) and, if applicable, special controls. These are regulatory requirements for all devices, not performance-specific acceptance criteria for this particular device.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth, or training set details as this information is not contained within the provided FDA 510(k) clearance letter.

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