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The Disposable Grounding Pad series devices are to conduct electrosurgical energy from target tissue of a patient back to an electrosurgical unit (ESU), or generator.

The Disposable Electrode series devices are intended to conduct radio frequency (RF) current for cutting and coagulation from the electrosurgical generator to target soft tissue in a broad range of surgical procedures requiring the use of electrosurgery for cutting and cauterization.

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The provided text is a 510(k) summary for a Disposable Grounding Pad Series and Disposable Electrode Series. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a study proving that the device meets specific performance acceptance criteria for a new clinical claim. Therefore, the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth for proving performance is not typically found within this kind of regulatory submission.

The document primarily states that:

• The device is designed and tested according to mandatory and voluntary standards (IEC 60601-1, IEC 60601-2-2).
• It is determined to be Substantially Equivalent (SE) to predicate devices (K063161 and K081791), implying it is as safe and effective.

Consequently, I cannot extract the specific details you've asked for, such as a table of acceptance criteria and reported device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, or results of MRMC or standalone studies, because these are not part of a substantial equivalence claim for this type of medical device's 510(k) submission.

The "Test Conclusion" section only mentions adherence to safety standards, not a clinical performance study with specific acceptance criteria.

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