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

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, or at least one of the major extra-hepatic bile 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 fluorescent mages 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.

The KARL STORZ ICG Imaging System is used to provide real-time high-definition (HD) endoscopic or telescopic images of visible (VIS) and near-infrared (NIR) indocyanine green (ICG) dye fluorescence during minimally invasive, neuro- and endonasal skull base surgery as well as plastic, micro- and reconstructive surgical procedures in general and pediatric populations.

The overall system includes a 4mm HOPKINS ICG/NIR Endoscope (0°, 30° or 45°) for use in neuro- and endonasal skull base surgery, a 5mm & 10mm HOPKINS ICG/NIR Endoscope (0° or 30°) for use in minimally invasive procedures and a VITOM II ICG/NIR Telescope for use in plastic, micro- and reconstructive surgical procedures for VIS and NIR illumination and imaging, a light source with foot switch for emission of VIS and NIR illumination, a color video camera head capable of capturing both VIS and NIR imaging, and a KARL STORZ ICG Kit. Additional accessories used with the KARL STORZ ICG Imaging System include two standards fiber-optic light cables for transmission of VIS and NIR light and the Image1 S Camera Control Unit (CCU). The KARL STORZ ICG Imaging System can be used with any medical grade HD monitor with a DVI-D or 3G-SDI input.

The provided text, K180146, describes the KARL STORZ ICG Imaging System, an endoscopic device for real-time visible and near-infrared fluorescence imaging, particularly for assessing vessels, blood flow, and tissue perfusion. The submission is a 510(k) for a modified device, primarily adding a 4mm endoscope for neuro- and endonasal skull base surgery in adults and pediatrics.

Based on the document, here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily defined by adherence to established standards for medical devices and demonstration of equivalence to predicate devices through bench testing and literature review. The document does not provide specific quantitative acceptance criteria for clinical performance (e.g., a specific sensitivity or specificity for detecting blood flow issues). Instead, it relies on demonstrating that the device meets its design specifications and performs comparably to the predicate devices and that the expanded indications are supported by existing clinical literature.

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

The document explicitly states: "Clinical performance is not required to demonstrate substantial equivalence to the predicate devices. Non-clinical bench testing was sufficient to establish substantial equivalence."

Therefore, there appears to be no specific "test set" of patient data for evaluating algorithm performance in the way one would for an AI/ML device. The evaluation relies on:

• Bench testing: This refers to laboratory-based functional and safety testing of the device hardware and software. The sample size for this is not specified in terms of "patients" or "cases" but rather in terms of components or test conditions. The provenance is internal to the manufacturer's testing facility.
• Clinical Literature: Published studies from various sources were used to support the expanded indications for use in neuro- and endonasal skull base surgeries and in pediatric populations. The provenance of this data is from the respective published articles (e.g., Journal of Neurological Surgery Part B, Neurologia Medico-Chirurgica). These are retrospective studies conducted by various researchers, not specifically "prospective" studies for this particular 510(k) submission.

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

Since no specific clinical "test set" for algorithm performance was used, there is no mention of experts for ground truth establishment in that context. The "ground truth" for the device's functional performance was established through engineering and quality control testing against design specifications and relevant standards. For the expanded indications, the "ground truth" is derived from the established scientific and clinical evidence presented in the published literature.

4. Adjudication method for the test set

Not applicable, as no clinical test set requiring expert adjudication for ground truth was generated for this submission.

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 MRMC study was conducted or referenced in this submission. This device is an imaging system (hardware and associated software), not an AI-based diagnostic algorithm intended to assist human readers in image interpretation. Its purpose is to generate the imaging data (visible and NIR fluorescence), not to interpret it in an AI-assisted manner.

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

Not applicable. The device itself is a tool for image acquisition, primarily used by surgeons for visual assessment during procedures. It does not perform an automated, standalone diagnostic algorithm.

7. The type of ground truth used

• For device performance validation: The ground truth was established by engineering design specifications and compliance with recognized industry standards (IEC, ISO, AAMI). This involved direct measurement and verification against established physical and electrical parameters.
• For expanded indications: The ground truth was established by published clinical literature related to the effectiveness and safety of NIR imaging using ICG in the specified surgical fields and pediatric populations. This relies on the expert consensus and evidence presented in those scientific publications.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a "training set" of data for learning. Its functionality is based on established optical and electronic principles.

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

Not applicable. As there is no AI/ML training set, there is no ground truth establishment for it.

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