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

Endoscopic ICG System
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 in adults and pediatric patients ≥1 month of age, and at least one of the major extrahepatic bile ducts (cystic duct, common bile duct and common hepatic duct) in adults and pediatric patients ≥ 12 years of age, using near infrared imaging in accordance with the appropriately indicated endoscope.
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.
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.

Exoscopic ICG System

VITOM ICG SYSTEM
The KARL STORZ VITOM 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 in adults and pediatrics ≥ 1 month of age.
The VITOM ICG System is intended to provide a magnified view of the surgical field.

RUBINA Lens System
The RUBINA Lens 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 in adults and pediatrics ≥ 1 month of age.
Upon interstitial administration and use of the ICG consistent with its approved label, the RUBINA Lens System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.
Upon intradermal administration and use of the ICG consistent with its approved label, the RUBINA Lens System is indicated for fluorescence imaging of lymph nodes and delineation of lymphatic vessels during lymphatic mapping in adults undergoing breast surgical procedures for which fluorescence imaging is a component of intraoperative management.
The RUBINA Lens System is intended to provide a wide-angle view of the surgical field.

The RUBINA® Lens supports anatomical visualization under white light and NIR/ICG fluorescence. Its native 16:9 full-screen image eliminates the need for digital zoom, enabling shorter working distances that help maintain fluorescence signal capture during procedures requiring continuous visualization of lymphatic or perfusion-related structures.

The device incorporates a wide-angle optical design and expanded focus range, supporting consistent imaging across variable working distances for applications such as:

• Fluorescence-guided assessment of tissue perfusion
• Visualization of lymphatic pathways and sentinel lymph nodes

The RUBINA® Lens features a 90° direction of view and may be used handheld or mounted to a compatible holding arm. Rotation of the attached camera head allows horizon adjustment to maintain anatomical orientation.

The system provides continuous white-light and NIR/ICG visualization for display on standard operating room monitors. The device achieves optimal illumination at approximately 18 cm and maintains fluorescence visualization across a broad working distance range, supporting use in applications such as perfusion assessment and lymphatic mapping.

The subject device RUBINA® Lens is compatible with the following components within the KARL STORZ ICG Imaging System:

• IMAGE1 S™ Rubina® camera head (TH121) previously cleared on K201399 and K202925.
• IMAGE1 S™ Camera Control Unit (CCU) (TC201US, TC304US) previously cleared on K212695, K201135, K233333, K232857.
• Fiber Light Cables (495NCSC, 495TIP): used to transmit visible and NIR light from the Power LED Rubina Light Source (TL400) to the RUBINA® Lens. The 495NCSC was previously cleared K201399, and K202925. The 495TIP Fiber Light Cable was most recently cleared in K233333.
• The Power LED Rubina® Light Source (TL400) previously cleared in K201399, K202925, K212695, K232857, and K233333. The TL400 is included as a subject device, as the KARL STORZ ICG Imaging System Indications for Use reflected in the TL400 labeling require revision within this 510(k). No modifications have been made to the TL400 with respect to materials, technological characteristics, performance, reprocessing, or any other essential design features.
• Footswitch (UF101): [Optional] Previously cleared in K201399, K202925, K212695, and K232857.

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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 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 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 ICG System is intended for capturing 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 in adults and pediatrics >Imonth of age. The VITOM ICG System is intended to provide a magnified view of the surgical field.

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 subject device KARL STORZ ICG System includes the following components:

1. VITOM EAGLE (TH201): a 3D video exoscope with 4K resolution used during open procedures for the evaluation of tissue perfusion, related tissue-transfer circulation in tissue and free flaps used in plastic, micro and reconstructive surgical procedures. The subject device VITOM EAGLE System is being indicated for use in in adults and pediatrics >1month of age.
2. Fiber Light Cable (495VTE): used to transmit visible and NIR light from the Power LED Rubina light source to the VITOM Eagle.
3. IMAGE1 Pilot (TC014): used to control the optical functions of the VITOM EAGLE.
4. Microscope Footswitch (TC019): alternatively used control the optical functions of the VITOM EAGLE
5. The Power LED Rubina light source (TL400) along with the footswitch (UF101): previously cleared in K201399, K202925 and K212695.
6. Imagel S Camera Control Unit (TC201US, TC304US): previously cleared in K201399, K202925 and K212695.

The provided text describes the KARL STORZ ICG Imaging System and its acceptance criteria, along with a summary of the non-clinical performance data used to demonstrate substantial equivalence to a predicate device. However, it does not describe a study involving an AI algorithm. The device is an imaging system that uses Indocyanine Green (ICG) fluorescence for various surgical visualizations.

Here's a breakdown of the requested information based only on the provided text, heavily noting limitations due to the absence of AI-specific study details:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a non-AI imaging system without specific AI performance metrics, the acceptance criteria are generally related to the technical performance of the imaging capabilities. The document states that the KARL STORZ ICG Imaging System (subject device) was compared to the predicate VITOM II ICG/NIR telescope of the KARL STORZ ICG Imaging System (K212695). The performance was demonstrated by testing for:

2. Sample size used for the test set and the data provenance

The document does not specify a "test set" in the context of an AI algorithm or patient data. The performance evaluation was based on non-clinical bench testing comparing the subject device's imaging capabilities to a predicate device. Therefore, there's no mention of sample size in terms of patient data or data provenance (country of origin, retrospective/prospective). The "sample" here would refer to the physical devices and controlled test scenarios.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. As this is a non-AI imaging system being evaluated via bench testing, there are no "experts" establishing ground truth for a test set of images or patient data. The ground truth for the technical performance criteria would be established by validated measurement techniques and instrumentation during the bench tests.

4. Adjudication method for the test set

Not applicable, as there is no "test set" in the context of human expert review or an AI algorithm's output. The evaluation was based on objective technical measurements.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. The document explicitly 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." Furthermore, this is not an AI-assisted device, so MRMC studies on AI assistance would not be relevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. The device is an imaging system, not a standalone AI algorithm. It produces images for human surgeons to interpret.

7. The type of ground truth used

For the non-clinical performance data, the ground truth was based on objective measurements from bench testing (e.g., measuring spatial resolution, signal-to-noise ratio, etc.) against established technical specifications or a predicate device's performance.

8. The sample size for the training set

Not applicable. The device does not involve an AI algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable, as there is no AI algorithm or training set.

Summary of AI-related information (or lack thereof):

The provided text describes a submission for a KARL STORZ ICG Imaging System, which is a medical device for real-time visible and near-infrared fluorescence imaging during surgery. The entire document focuses on demonstrating the substantial equivalence of this updated imaging system to a previously cleared predicate device through non-clinical bench testing. There is no mention of any artificial intelligence (AI) component, machine learning model, or any studies related to AI performance, human-in-the-loop improvements with AI, or standalone algorithm performance. Therefore, most of the questions regarding AI-specific criteria cannot be answered from the provided text.

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