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ArtiSential Laparoscopic Instruments-Electrodes, Monopolar Series are indicated for cutting and coagulation in endoscopic, gynecological, and general abdominal and thoracic and general laparoscopic procedures.

This product is sterile, single-use, invasive instrument that used in laparoscopic surgery. There are two Version, one for Hook and Spatula. The two models are same except for jaw. This product is a specific component, but not the entire electrosurgical device. The device is not intended to be marketed with multiple components, accessories, and as part of a system.

The provided text is a 510(k) premarket notification for a medical device (ArtiSential Laparoscopic Instrument-Electrodes). It primarily focuses on demonstrating substantial equivalence to predicate devices, rather than describing a clinical study with acceptance criteria and performance results in the context of an AI/ML medical device.

Therefore, the document does not contain the information requested regarding acceptance criteria related to a specific study proving the device meets those criteria, especially in the context of an AI/ML device that would involve a test set, expert ground truth, MRMC studies, or standalone algorithm performance.

The "Performance Data" section details engineering and biological safety tests typical for a medical instrument:

• Biocompatibility: Evaluated according to ISO 10993-1 for cytotoxicity, sensitization, intracutaneous reactivity, and acute systemic toxicity.
• Electrical Safety: Tested according to IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-18, and IEC 60601-2-2 (various tests like insulation, leakage, dielectric strength).
• Sterilization: EO-Sterilization in accordance with ISO-11135.
• Shelf life: Proposed expiration of 2 years, with real-time testing for 3 years.
• Performance test: Passed appearance, dimension, operational, tensile strength, and feedthrough tests. Thermal effects were demonstrated in 3 pigs on liver, kidney, and abdominal muscle tissues.

In summary, none of the requested categories related to acceptance criteria, test set characteristics (sample size, provenance), expert involvement (number of experts, qualifications, adjudication), MRMC studies, standalone performance, or ground truth for AI/ML validation are present in this document. The document states that "Results demonstrated the subject device can perform the intended use safely and effectively" and "the performance requirements were met," but it does not define these "performance requirements" as specific, quantifiable acceptance criteria in a table or describe a formal clinical study with ground truth establishment in humans.

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