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The HM-930 Electrosurgical unit is to be used in order to cut and coagulate the skin in surgical procedures.

The HM-930 Eletrosurgical unit has been design to provide the broadest possible range of electrosurgical capabilities. This unit provide monopolar cutting and coagulation capabilities for most demanding procedures. This device can be used for multi-purposes and has the capabilities necessary to perform any particular need.

The provided document is a 510(k) premarket notification for the Hill-Med HM-930 Electrosurgical Unit. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria through clinical trials or performance studies with human subjects.

Therefore, the document does not contain the information requested regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

Instead, the document primarily focuses on:

• Device Description: What the HM-930 Electrosurgical Unit does (monopolar cutting and coagulation capabilities).
• Intended Use: To cut and coagulate the skin in surgical procedures.
• Comparison to Predicate Device: How the HM-930 is similar to and differs from the HM-880II Electrosurgical Unit (e.g., RF Output Waveforms, presence of cutting coagulation and bipolar outputs, alarms, digital display). The key difference mentioned is the RF Output Waveform (500 Khz for HM-930 vs. 300 Khz for HM-880II).
• Conclusion of Substantial Equivalence: The manufacturer asserts that the HM-930 is substantially equivalent to the predicate device.
• FDA Response: The FDA's letter confirming substantial equivalence based on the provided information.

To answer your prompt, a clinical study with acceptance criteria would typically involve metrics like safety endpoints (e.g., rates of adverse events, burns) and effectiveness endpoints (e.g., successful tissue cutting/coagulation, hemostasis, healing rates). Such studies are not part of this 510(k) submission, which relies on the established safety and effectiveness of the predicate device.

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