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The KARL STORZ ICG Imaging System is intended to provide real-time visible (VIS) and near-infrared (NIR) fluorescence imaging.

Upon intravenous administration and use of ICG consistent with its approved label, the KARL STORZ Endoscopic ICG 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 and common hepatic duct), using near infrared imaging. Fluorescence imaging of biliary ducts with the KARL STORZ Endoscopic ICG 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. Additionally, the KARL STORZ Endoscopic ICG System enables surgeon to perform minimally invasive cranial neurosurgery in adults and pediatrics and endonasal skull base surgery in adults and pediatrics > 6 years of age using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion using near infrared imaging.

The KARL STORZ VITOM II ICG System is intended for capturing and viewing fluorescent images for the visual assessment of blood flow, as an adjunctive method for the evaluation of tissue perfusion, and related tissue-transfer circulation in tissue and free flaps used in plastic, micro- and reconstructive surgical procedures. The VITOM II ICG System is intended to provide a magnified view of the surgical field in standard white light.

Upon interstitial administration and use of ICG consistent with its approved label, the KARL STORZ Endoscopic ICG System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.

The modified KARL STORZ ICG Imaging System is identical to the KARL STORZ ICG Imaging System recently cleared under K202925. The modified KARL STORZ ICG Imaging System now includes the following components: TIPCAM®1 Rubina Videoscope (0°, 30°): a 3D image capable videoendoscope with 2D auto-leveling (auto-rotation) and 2D auto-switch display modes.

The 4mm, 5mm & 10mm Endoscopes and VITOM ICG telescopes connected to the optical coupler of the Image1 S 4U Rubina camera head, and the TIPCAM®1 Rubina Videoendoscope which connects to the Image1 S Camera Control Unit for image processing, as well as to the Power LED Rubina light source light source via compatible light cable as the source of illumination to allow visualization of internal anatomy. Visualization and navigation is performed initially using VIS imaging. NIR imaging is selected when visual assessment and/or confirmation of vessels, blood flow or tissue perfusion is desired.

For the NIR image, the user has three presentations of the ICG imagery to choose from:
a. Overlay: The white light image is overlaid with the NIR image. The NIR image could either by blue or green
b. Intensity Map: The white light image is overlaid with color transformed NIR image.
c. Monochromatic: The NIR image is indicated by the color white against a dark background.

The KARL STORZ ICG Imaging System can output a 4K image to the monitor 12G/3G-SDI, DVI-D and DisplayPort digital outputs and also offers 7 increments of zoom ranging from 1x to 2.5x.

The reference device, TIPCAM1 Rubina Video Endoscope System, is identical in design and materials of construction to the subject device. The only difference is that the ICG functionality was not included as part of K201526.

The provided text does not describe a study involving an AI/Machine Learning device. Instead, it is a 510(k) premarket notification for the KARL STORZ ICG Imaging System, which is an endoscopic imaging system used to provide real-time visible and near-infrared fluorescence imaging.

The document states:

• "Clinical testing was not required to demonstrate the substantial equivalence to the predicate devices. Non-clinical bench testing was sufficient to establish the substantial equivalence of the modifications." This explicitly indicates that no comparative clinical study (including MRMC or standalone performance with human-in-the-loop) was performed or needed for this specific submission (K212695).
• The acceptance criteria and performance data mentioned are related to non-clinical bench testing to ensure the device met its design specifications and conformed to various electrical safety, EMC, and ISO endoscopic standards, as well as software verification and validation. This is typical for optical/imaging hardware devices rather than AI algorithms.
• There is no mention of "ground truth" in the context of diagnostic accuracy, nor any experts establishing such ground truth.

Therefore, providing answers to the requested points about AI acceptance criteria, study sample sizes, expert involvement, and ground truth establishment would be inaccurate as this information is not present in the provided text, because the device described is not an AI device.

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