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The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use. It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.

The da Vinci® Firefly™ Imaging System is intended to provide real-time endoscopic visible and near-infrared fluorescence imaging. The da Vinci Firefly Imaging System enables surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct or common hepatic duct), using near infrared imaging.

Fluorescence imaging of biliary ducts with the da Vinci Firefly Imaging System is intended for use with standard of care white light and, when indicated, intraoperative cholangiography. The device is not intended for standalone use for biliary duct visualization.

The da Vinci Xi 8 mm Endoscope was originally cleared under K131861 on March 28, 2014, for use with the da Vinci® Surgical System, Model IS4000. Additional features and indications were cleared under K141077 on August 12, 2014, to add the da Vincio Firefly" Imaging System. The Intuitive Surgical da Vinci® Firefly™ Imaging System uses the endoscope submitted in the original 510(k) K131861 for high definition (HD) visible light imaging and near-infrared fluorescence imaging during minimally invasive surgery.

This document is a 510(k) premarket notification for a medical device, specifically the da Vinci Xi 8mm Endoscope. It focuses on demonstrating substantial equivalence to a predicate device rather than proving a new device's independent safety and effectiveness through clinical trials with specific acceptance criteria related to disease detection or diagnosis.

Therefore, the information requested in your prompt (acceptance criteria for AI performance, sample sizes for training/test sets, expert adjudication, MRMC studies, ground truth establishment) is not present in this regulatory document. This document primarily describes design verification and validation for physical and functional characteristics of an endoscopic device, not an AI/ML diagnostic or prognostic tool.

The "Performance Data" section (page 4) lists general categories of bench testing performed:

• Optical
• Illumination
• Mechanical
• Temperature
• Electrical
• Hardware/software compatibility
• Functional
• Reliability/life
• Labeling

It states that "Design verification and design validation testing were conducted on the subject device to confirm that the design outputs meet design input requirements and that the device is safe and effective for its intended use." And "Design Validation Testing was performed to confirm that the design modifications to the predicate device do not raise new questions of safety and effectiveness."

In summary, this document does not contain the type of AI/ML performance data, acceptance criteria, or study design details that your prompt is asking for. It's a regulatory submission for an updated surgical endoscope, not an AI-powered diagnostic device.

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