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The Liger Medical ESU-110 is intended to deliver high frequency electrical current for surgical procedures that can be performed with monopolar cutting and/or coagulation of tissue. One intended use of the Liger Medical ESU-110 Electrosurgical Unit is Loop Electrosurgical Excision Procedure (LEEP).

The Liger Medical ESU-110 combines a high-quality, class I type BF electrosurgical generator and a smoke evacuation system into a single, compact unit. This integrated system is designed to perform low-power excision procedures of short duration. The ESU-110 is designed to be portable, single-purpose, and is intended for non-hospital locations where A/C power may be unreliable or unavailable.

The prompt asks for details about the acceptance criteria and the study that proves the device meets them. However, the provided text describes an Electrosurgical and Suction Unit (ESU-110), which is a hardware device, not a software-based AI/ML device.

Therefore, the requested information regarding acceptance criteria, study design for AI/ML performance (e.g., sample size for test set, data provenance, expert consensus, MRMC study, standalone performance, training set details) is not applicable to this document.

The document focuses on demonstrating substantial equivalence of the ESU-110 to predicate devices (Finesse 3rd Generation and Aaron 950) based on:

• Device Description and Functionality Comparison: Highlighting similarities in operation, though simpler due to single-purpose design (low power, fixed output).
• Safety and Performance Standards Conformance: Stating that the ESU-110 conforms to IEC 60601-1-2:2007 (electrical and electromagnetic safety) and IEC 60601-2-2:2009 (patient protection, neuromuscular stimulation, excessive temperatures, spillage, output indication, short circuits).
• In-house Testing: Claiming that these safety concerns were tested in-house by Liger Medical and found to meet or exceed all applicable requirements. This in-house testing constitutes the "study" for this device, proving its safety and performance aspects relevant to electrical and physical standards.

Therefore, I cannot provide the requested table and details because the input document does not pertain to an AI/ML device and thus does not contain the specified categories of information.

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