(72 days)
The Trigger Switch and Cord accessories are intended for use in monopolar laparoscopic and thoracoscopic electrosurgical procedures where handswitching of laparoscopic or thoracoscopic instruments, such as scissors and graspers, is desired.
The Trigger laparoscopic switch system consists of a sterile, single use switch and a sterile single use cord that is used to deliver monopolar RF current from a standard electrosurgical generator to a laparoscopic or thoracoscopic instrument.
The switch contains a female electrical connector that mates with the electrosurgical connector post on a laparoscopic or thoracoscopic instrument and a male connector that mates with the power cord. The adhesive on the switch button allows it to be placed on the instrument in a user-selected location. When the switch assembly is connected via the power cord to an electrosurgical generator, depression of the switch button results in the activation of the coagulation output of the generator.
This document describes a medical device, the "Trigger Switch and Cord," which is an accessory for electrosurgical procedures. However, the provided text does not contain any information related to AI or machine learning performance, nor does it describe a study involving an AI device.
Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving the device meets those criteria in the context of AI. The provided text outlines the device's intended use, its components, how it functions, and the standards it has been tested against (IEC 601-1, IEC 601-2-2, ANSI/AAMI HF18). It also states that it's "substantially equivalent" to other legally marketed devices based on its function and intended use.
Here's why I cannot provide the requested information based on the input:
- No AI Device: The document describes a physical medical accessory (a switch and cord) for electrosurgical procedures. There is no mention of an AI component, software, algorithm, or any form of artificial intelligence.
- No Performance Metrics for AI: The document doesn't discuss metrics like sensitivity, specificity, AUC, F1 score, or other performance indicators typically associated with AI device evaluation.
- No Testing Methodologies for AI: There is no mention of test sets, training sets, ground truth establishment, expert review processes, MRMC studies, or standalone algorithm performance, which are standard for AI device validation.
- Compliance with Electrical Safety Standards: The testing mentioned (IEC 601-1, IEC 601-2-2, ANSI/AAMI HF18) are electrical and general medical device safety standards, not performance or validation studies for AI algorithms.
If you have a different document or information pertaining to an AI medical device, I would be happy to analyze it according to your requested criteria.
§ 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.