(77 days)
Indications for use include electrosurgical coagulation, dissection, and grasping of tissue during the performance of laparoscopic and general surgical procedures.
The ArtiSential Laparoscopic Instruments - Electrodes, Bipolar series are sterile, single-use, invasive instruments that used in laparoscopic surgery. There are three versions, ABF01 series, and ABD02 series. Three versions are same except for jaw shape. 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 describes a 510(k) premarket notification for a medical device, specifically the "ArtiSential Laparoscopic Instruments - Electrodes". This document asserts the substantial equivalence of the new device to a predicate device (K190909) and details various performance tests conducted.
However, it does not contain information related to acceptance criteria, reported device performance in those terms, sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment for AI/ML device studies. The document describes a traditional medical device (surgical instruments) and its non-AI related testing for regulatory clearance.
Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study that proves an AI/ML device meets them based on the provided text. The document focuses on demonstrating substantial equivalence to a predicate device through manufacturing and basic performance testing, not on the validation of an AI/ML component.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.