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The Heartport Handswitch Electrocautery Probe is used in conjunction with standard electrosurgical generators for the hemostatic dissection of tissue and coagulation of blood. The long, narrow shaft allows the device to be used during the endoscopic takedown of the Internal Mammary Artery. The probe's central lumen allows for the evacuation of smoke generated by electrocautery as well as the removal of fluid from the thoracic cavity. The central lumen may also be used to provide irrigation fluid to the surgical site.

The Heartport Handswitch Electrocautery Probe is a device used in conjunction with standard electrosurgical generators for the hemostatic dissection of tissue and coagulation of blood. It has a long, narrow shaft and a central lumen for smoke evacuation, fluid removal, and irrigation.

Here's an analysis of the provided text regarding acceptance criteria and study information:

The provided text describes a 510(k) summary for a "Handswitch Electrocautery Probe." However, this document does not contain the information requested for a detailed description of acceptance criteria and a study proving a device meets these criteria in the context of an AI/medical imaging device.

The document focuses on:

• Device Identification: Trade name, common name, classification, and applicant information.
• Intended Use: Description of what the electrocautery probe is designed to do (dissect tissue, coagulate blood, evacuate smoke/fluid).
• Predicate Devices: Identifying similar devices already on the market.
• Non-Clinical Test Results: Brief statements on performance (dissecting/cauterizing tissue, evacuating smoke/fluids) and biocompatibility.
• Summary of Substantial Equivalence: Concluding that the device is substantially equivalent to predicates.

It lacks any mention of AI, diagnostic imaging, or the specific types of performance metrics that would be associated with AI-driven medical devices (e.g., sensitivity, specificity, AUC). Therefore, it's impossible to fill out the requested table and answer the questions based on this input.

Given the nature of the input, it seems to be a regulatory submission for a physical medical device (an electrocautery probe) rather than a software as a medical device (SaMD) or an AI-powered diagnostic tool. The questions you've asked are highly relevant for AI/ML medical devices, but the provided text doesn't cater to those.

If you can provide a different document that pertains to an AI-driven medical device, I would be able to answer your questions thoroughly.

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