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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 cCeLL - In vivo with Drop-In Robo is a confocal laser system with fiber optic probe that are intended to allow imaging of the internal microstructure of tissues including, but not limited to, the identification of cells, vessels and their organization or architecture.

Upon intravenous administration and use of an ICG consistent with its approved labeling, the cCeLL - In vivo with Drop-In Robo is used to perform fluorescence angiography.

Upon administration and use of ICG consistent with its approved labeling, the cCeLL - In vivo with Drop-In Robo is used to perform fluorescence imaging to support the visual assessment of vessels, blood flow, and related tissue perfusion.

The Drop-In Robo is intended to provide visualization of organs and canals during endoscopic and laparoscopic surgical procedures, including robot-assisted procedures.

The cCeLL - In vivo with Drop-In Robo, which is a confocal imaging system with fiber optic probes which allows visualization of internal microstructure of tissues and blood flow including, but not limited to, the identification of cells, vessels and their organization or architecture, during endoscopic and laparoscopic surgical procedures, including robot-assisted procedures.

To achieve this function, the cCeLL - In vivo with Drop-In Robo has been designed:

• To excite fluorescent components within the human tissue with the laser light emitted by the Main Unit at 775nm.
• To receive fluorescence signal emitted from tissue microstructures within the spectral detection bandwidth of the Main Unit 813-850 nm.

The indocyanine green absorbs light in the near-infrared region with peak absorption at 805 nm and emits fluorescence (light) at a slightly longer wavelength, with peak emission at 830 nm.

The device can excite ICG in the vascular system and image signal emitted by ICG in the vascular system after ICG has been administered to the patient according to its approved labeling dose.

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The IMAGE1, a camera control unit (CCU), when used with compatible camera heads or videoendoscopes and ancillary equipment, is intended to provide real-time visible (VIS) and near-infrared (NIR) fluorescent imaging and documentation of endoscopic and microscopic procedures in adults and pediatrics.

The X-to-4U Adapter, as ancillary equipment, is intended to connect compatible camera heads or videoendoscopes to the IMAGE1 CCU.

The IMAGE1 CCU is the next generation KARL STORZ CCU designed for use by medical professionals in an OR setting to provide real-time visible (VIS) and near-infrared (NIR) fluorescent imaging and documentation of endoscopic and microscopic procedures. The IMAGE1 CCU performs image processing functions including color processing, color filtration, and image enhancement and is compatible with many KARL STORZ C-Line and 4U connector type camera heads. Software extensions and applications can be purchased by the user and downloaded onto the CCU to provide additional features beyond those of the default set.

For compatibility with the X-link connector type camera head and videoendoscopes, IMAGE1 requires the X-to-4U adapter. The X-to-4U Adapter provides an electromechanical interface between the X-Line family of Flexible Videoendoscopes and the 4U-Receptacle of the IMAGE1 CCU.

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Upon intravenous administration of SPY AGENT GREEN (indocyanine green for injection, USP), the L12 LED Light Source with Advanced Imaging Modality and SafeLight Cable are used with SPY AGENT GREEN to provide real-time endoscopic visible and near infrared fluorescence imaging. The L12 LED Light Source with Advanced Imaging Modality and SafeLight Cable enable 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 aged one month and older, and visualization of at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct) in adults and pediatric patients 12 to 17 years of age, using near-infrared imaging.

Fluorescence imaging of biliary ducts with the L12 LED Light Source with Advanced Imaging Modality and SafeLight Cable is intended for use with standard-of-care white light and, when indicated, intraoperative cholangiography. The devices are not intended for standalone use for biliary duct visualization.

Additionally, the L12 LED Light Source with Advanced Imaging Modality and SafeLight Cable enable surgeons to perform minimally invasive cranial neurosurgery in adults and pediatric patients and endonasal skull base surgery in adults and pediatric patients > 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 of SPY AGENT GREEN, the L12 LED Light Source with Advanced Imaging Modality and SafeLight Cable are used to perform intraoperative fluorescence imaging and visualization of the lymphatic system,including lymphatic vessels and lymph nodes.

Upon administration and use of pafolacianine consistent with its approved label, the L12 LED Light Source with Advanced Imaging Modality and SafeLight™ Cable are used to perform intraoperative fluorescence imaging of tissues that have taken up the drug.

The L12 LED Light Source with Advanced Imaging Modality is also intended to transilluminate the ureter during open or laparoscopic surgical procedures.

The L12 LED Light Source with AIM is part of the Advanced Imaging Modality (AIM) System. The system is an endoscopic real-time 4K visible white light and near-infrared illumination and transillumination imaging system. Near-infrared illumination is used for fluorescence imaging using indocyanine green and pafolacianine injection. Near-infrared illumination is also intended for use during transillumination of the ureters using the IRIS Ureteral Kit during minimally invasive and open surgical procedures. The L12 LED Light Source is a light-generating unit designed to illuminate surgical sites in the following applications: visible light, near-infrared fluorescence, and near-infrared transillumination.

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The VISERA ELITE III Surgical Imaging System is intended to provide real-time visible and near infrared fluorescence imaging.

Upon intravenous administration and use of ICG consistent with its approved label, VISERA ELITE III Surgical 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 and common hepatic duct), using near infrared imaging.

Fluorescence imaging of biliary ducts with the VISERA ELITE III Surgical 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.

Upon interstitial administration and use of ICG consistent with its approved label, the VISERA ELITE III Surgical Imaging System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.

The VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700 is intended to process electronic signals transmitted from a video endoscope/camera head and output image signal to monitor, and to be used with endoscopes, video endoscopes, camera heads, light sources, monitors and other ancillary equipment for endoscopic diagnosis, treatment, and observation.

The VISERA ELITE III LED LIGHT SOURCE OLYMPUS CLL-S700 is intended to provide light to an endoscope/video endoscope in order to process electronic signals transmitted from them and output image signal to monitor, and to be used with endoscopes, video endoscopes, camera heads, video system centers, monitors and other ancillary equipment for endoscopic diagnosis, treatment, and observation.

The 4K CAMERA HEAD OLYMPUS CH-S700-XZ-EA is intended to be used with endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment, and observation.

The VISERA ELITE III Surgical Imaging System is intended to be used with ancillary equipment for endoscopic diagnosis, treatment, and observation and supports the function of high definition (HD) videoscopes and is Camera Head (CH) compatible.

The following subject devices of the OLYMPUS VISERA ELITE III Surgical Imaging System are identical to and unchanged from the VISERA ELITE III Surgical Imaging System (K242067):

• VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700 (Model Number: OLYMPUS OTV-S700) – OLYMPUS OTV-S700 is a video system center that processes electronic signals transmitted from a video endoscope or a camera head and outputs the image signal to a monitor.

  • OTV-S700 3D UPGRADE PACK (Model Number: OLYMPUS MAJ-2511) – A function activation portable memory key accessory that unlocks the 3D software function when connected with VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700 to enable 3D observation mode.

• VISERA ELITE III LED LIGHT SOURCE OLYMPUS CLL-S700 (Model Number: OLYMPUS CLL-S700) – A LED light source that provides examination light to a video endoscope and a camera head.

• 4K Camera Head OLYMPUS CH-S700-XZ-EA (Model Number: OLYMPUS CH-S700-XZ-EA) – A 4K Inline camera head is intended to be used with Olympus endoscopes, the video system center, and other ancillary equipment for the visualization of internal organs (Endoscopic diagnosis), treatment and observation.

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The Confocal Microprobe Imaging System can enter the human body cavity or surgical channel through an endoscope, allowing confocal laser imaging of the microstructure of tissues, including but not limited to the identification of cells, vessels and their organization or architecture.

The working principle of Confocal Microprobe Imaging System is based on probe-based confocal laser endomicroscopy technology (pCLE). The system combines confocal technology and fiber beam imaging technology. The fiber Optic Microprobe can enter the human cavity through the endoscopic working channel and contact the tissue cells through the object lens at the front end of the Fiber Optic Microprobe. The imaging principle of the device is as follows:

The laser scanning beam emitted by the laser in the Laser Scanning System forms a light source through the grating pinhole and is transmitted to the focal plane of the fluorescent labeled tissue cells through the Fiber Optic Microprobe. The fluorescent substance in the measured tissue cell emits fluorescence under the excitation of the laser. The fluorescence signal is collected by Fiber Optic Microprobe front end object lens and transmitted through the fiber beam microprobe to the detecting hole and then is transmitted to the photomultiplier tube (PMT) of the Photoelectric detector and then to the host for signal analysis and processing. Finally, the image is formed on the computer monitoring screen after software processing.

Light emitted at the top and bottom of the focal plane of the tested tissue produces a large diameter spot (much larger than that of the detecting hole) at the detecting hole, thus only a very small part of the light can be received by the detector through the detecting hole. Moreover, the larger the distance from the focal plane of the object lens, the larger the diffuse spot produced by the non-targeted tissue in the detecting hole and the lesser energy passes through the detecting hole (from 10% to 1%, slowly close to 0%), thus the weaker the unwanted signal is generated on the detector, and smaller the impact is caused by non-targeted tissue. Because confocal microscopy only images the focal plane of the target tissue, it effectively avoids the interference of diffracting light and scattered light, so that it has a higher resolution than ordinary microscopy and has been widely used in biology.

It appears that the provided FDA 510(k) Clearance Letter does not contain detailed information about a clinical study involving human readers or a specific "acceptance criteria" table with reported performance metrics for an AI component.

The document discusses the Confocal Microprobe Imaging System, which is a hardware device for imaging tissues. While it mentions "software" and "cybersecurity," these sections focus on general software validation and cybersecurity considerations, not the performance evaluation of an AI algorithm designed to interpret or analyze the images beyond the device's basic function.

The "Performance Testing" section states that "Performance Verification Test has been conducted in accordance with the internal performance requirements stated in the Performance Validation Scheme (HRD0003932 & HRD0004124)" and lists technical performance requirements like "Field of view, Horizontal resolution, Depth of Observation, Frame rate." These relate to the imaging system's hardware performance, not an AI's diagnostic accuracy.

Therefore,Based on the provided FDA 510(k) clearance letter, I cannot fulfill your request for detailed information regarding acceptance criteria for an AI component and the study that proves the device meets those criteria. The letter primarily addresses the clearance of a Confocal Microprobe Imaging System (hardware), focusing on its substantial equivalence to predicate devices based on technological characteristics, biocompatibility, reprocessing, electrical safety, and general software/cybersecurity validation.

There is no mention of an AI-specific component, its performance criteria, or any clinical studies (e.g., MRMC studies) pertaining to AI algorithm performance within this document. The "Performance Testing" section refers to the optical and functional performance of the imaging system itself, not the diagnostic performance of an AI that might interpret the images generated.

If such an AI component exists, its performance evaluation would typically be described in a separate section with specific metrics like sensitivity, specificity, or AUC, and details about the study design (test set, ground truth, expert adjudication, etc.). This information is absent in the provided text.

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Upon intravenous administration of ICG(Indocyanine green for injection) consistent with its approved label, the OPTOVISION provides real-time endoscopic visible and near-infrared fluorescence imaging. The OPTOVISION enable surgeons to perform minimally invasive surgery using standard endoscope visual 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 OPTOVISION is intended for use with standard-of-care white light and, when indicated, intraoperative cholangioaraphy. The device is not intended for standalone use for biliary duct visualization.

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

OPTOVISION is an endoscopic light source that enables real-time endoscopic visible and nearinfrared fluorescence imaging minimally invasive surgical procedures. Near-infrared illumination is used for fluorescence imaging using indocyanine green (ICG). This device is largely composed of a power circuit, a control circuit, and a lighting lamp (light source). A power circuit provides power to the lighting lamp and cuts off the power in an emergency, a control circuit controls the light output (intensity)/other settings of light rays, and a light source unit irradiates light directly to the Light Guide Cable (K111342) for observation of the affected area. With the configuration above, the power input from the initial power source is transmitted to the light source unit and the main body, and rays of white light and near-infrared light are directly irradiated through the Light Guide Cable to the affected area for observation. This device is designed for use in the following applications: standard endoscopic visible-light imaging and near-infrared fluorescence imaging.

The provided FDA 510(k) summary (K243591) for the "OPTOVISION Endoscopic Light Source Unit" describes the device and its comparison to a predicate device, but it does not present an acceptance criteria table or report specific device performance metrics in the way typically seen for AI/ML device studies (e.g., sensitivity, specificity, AUC).

Instead, this submission is for an endoscopic light source, and its "performance" is demonstrated through compliance with established electrical, electromagnetic, usability, photobiological safety, and software validation standards, as well as a general "Performance - Bench" test. This type of device, an endoscopic light source, does not inherently involve an AI algorithm with output metrics like those you've requested. Thus, many of the specific questions about sample sizes, expert ground truth, adjudication, MRMC studies, and standalone performance are not applicable to the information provided.

However, I can extract and present the available information in a structured format as best as possible, noting where the requested details are not present in the document.

Explanation regarding the absence of typical AI/ML study information:

The "OPTOVISION Endoscopic Light Source Unit" is classified as an "Endoscope And Accessories" (21 CFR 876.1500) with product code OWN, which refers to "Confocal Optical Imaging". This device is a light source that enables real-time endoscopic visible and near-infrared fluorescence imaging using Indocyanine green (ICG). While it uses near-infrared light for fluorescence imaging, the document does not describe it as an AI/ML device that performs diagnosis or prediction, hence the absence of metrics like sensitivity, specificity, and the related study design details. Its "performance" is primarily assessed against safety and engineering standards.

Acceptance Criteria and Device Performance (Based on available information)

Since this is an endoscopic light source, the "acceptance criteria" are compliance with relevant safety and performance standards for medical electrical equipment and usability. The "reported device performance" is the successful passing of these tests.

Study Details (Based on available information)

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not applicable. The "performance data" describes compliance with engineering and safety standards, not a clinical study on a population of patients or data sets in the context of AI/ML.
   • Data Provenance: Not applicable. The "tests" are engineering and safety evaluations of the device itself.

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

   • Not applicable. This device is a light source, not an AI/ML algorithm requiring expert-established ground truth for its output. The "ground truth" for these tests would be the specifications and requirements of the standards themselves.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable. This type of adjudication is for disagreements in expert readings/labeling, which does not apply to compliance testing against engineering standards.

4. 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 done, as this device is a light source and not an AI assistant intended to improve human reader performance.

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

   • Not applicable. This is not an AI algorithm performing a standalone task. Its function is to provide illumination for human visualization.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Not applicable. The "ground truth" for the performance data are the requirements and specifications defined by the referenced international and national standards (e.g., IEC, ES standards) for medical device safety, EMC, usability, photobiological safety, and software.

7. The sample size for the training set:

   • Not applicable. The device is not an AI/ML model that requires a training set.

8. How the ground truth for the training set was established:

   • Not applicable. As above, there is no AI/ML training set.

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The Histolog® Scanner is a confocal laser system intended to allow imaging of the internal microstructure of tissues including, but not limited to, the identification of cells, vessels and their organization or architecture.

The Histolog® Scanner is a digital microscopy scanner for use on excised human tissue. Its operating principle is based on confocal fluorescence microscopy and uses non-ionizing, lowpower optical radiation (Class 1 laser product as per IEC 60825-1:2014-05). The Histolog® Scanner acquires digital images with high, micrometer-range resolution and enables the visualization of tissue microstructures down to the cellular level.

The Histolog® Scanner is based on a massively parallel signal acquisition and processing technology providing fast digital imaging over large areas. Image reconstruction does not involve any image stitching or any other similar image blending algorithms. Each pixel in the image is assigned an intensity value based on the light intensity collected by the detector for this particular position in the scan pattern.

The provided text does not contain the detailed information required to fulfill all aspects of the request regarding the device's acceptance criteria and the study proving it meets them. The document focuses on the regulatory submission and comparison to a predicate device, rather than a detailed clinical performance study.

Here's a breakdown of what can and cannot be extracted from the provided text:

What can be extracted:

• Acceptance Criteria for Non-Clinical Tests: The document lists acceptance criteria for various non-clinical performance and safety tests.
• Results for Non-Clinical Tests: The document states "PASS" for all listed internal validation tests.

What cannot be extracted (critical for a clinical performance study):

• Table of Acceptance Criteria and Reported Device Performance for Imaging Quality (Clinical): While "Imaging Quality" is listed as a test, the specific acceptance criteria (e.g., sensitivity, specificity, accuracy for a specific diagnostic task) and the actual reported performance values are not provided. The text only says "Histolog® Scanner system imaging requirements verification protocols. All requirements met." This is insufficient for a clinical performance study.
• Sample size used for the test set and data provenance: No information on the number of images/patients, or whether the data was retrospective/prospective or its origin.
• Number of experts used to establish ground truth and qualifications: No mention of experts or their qualifications.
• Adjudication method for the test set: No information.
• MRMC comparative effectiveness study details: No mention of human readers or AI assistance in a comparative study.
• Standalone (algorithm only) performance: While the device images tissue, there's no mention of an algorithm being evaluated in a standalone capacity against a ground truth. The device itself is the "scanner."
• Type of ground truth used: No mention of ground truth (e.g., pathology, outcomes).
• Sample size for the training set: The document discusses validation, not training.
• How the ground truth for the training set was established: Not applicable, as training data and ground truth establishment for AI are not mentioned.

Based on the provided text, here is the information that can be extracted and a clear indication of what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

For non-clinical safety and performance tests:

Missing: Specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy) and corresponding reported performance metrics for "Imaging Quality" related to the device's diagnostic capabilities or image interpretation for identifying specific microstructures (cells, vessels, organization). The document confirms internal verification protocols were met, but doesn't detail these protocols or their outcomes for clinical relevance.

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

Missing: No information regarding the sample size of any test set (e.g., number of tissue samples, patients, or images) used for evaluating the device's clinical performance or imaging quality related to microstructure identification. Data provenance (country of origin, retrospective/prospective) is also not provided.

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

Missing: The document does not describe any expert involvement in establishing ground truth for a test set.

4. Adjudication method for the test set

Missing: No information on an adjudication method.

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

Missing: No MRMC study is described. The device is a scanner intended for imaging the microstructure of tissues, not explicitly an AI-assisted diagnostic tool for human readers based on this submission.

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

Missing: While the device performs standalone imaging, the document doesn't describe a separate "algorithm only" performance evaluation that would assess, for example, automated detection or classification capabilities without human interpretation of the images. The device itself is the imaging system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Missing: No information on the type of ground truth used for any clinical performance or imaging quality assessment.

8. The sample size for the training set

Missing: No information on a training set, as the document focuses on device performance validation rather than machine learning model development.

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

Missing: Not applicable, as detailed training data and its ground truth establishment are not mentioned.

Conclusion: The provided FDA submission letter and summary focus explicitly on demonstrating substantial equivalence to a predicate device primarily through non-clinical performance and safety data, and a high-level statement about meeting "imaging quality" requirements. It does not present a clinical performance study with detailed acceptance criteria, sample sizes, ground truth establishment, or human reader performance metrics that would be typical for an AI/CADe device or a device requiring such detailed clinical validation.

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KARL STORZ ICG Imaging System
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 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.

VITOM II ICG System
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.

KARL STORZ Image1 S CCU
The Imagel S camera control unit (CU) in combination with either a compatible camera head or an appropriately indicated video endoscope is intended for real-time visualization, image recording and documentation during general endoscopic and microscopic procedures in adults and pediatrics.

KARL STORZ ICG Imaging System
The KARL STORZ ICG Imaging System is intended to provide real-time visible (VIS) and near-infrared (NIR) fluorescence imaging for general surgical sites including the abdomen, bile ducts, brain/skull base, and the lymph nodes/lymphatic vessels. Components of the system include:
Scopes:
3D TIPCAM®1 Rubina videoendoscope
26006ACA/BCA, 26616ACA/BCA Rigid Endoscope
26003ACA/ARA/BCA/BRA/FCA/FRA/FCEA/FREA
26046ACA/ARA/BCA/BRA/FCA/FRA
28164AC/BC/FC VITOM II ICG/NIR Telescope
20916025AGA

Light Source:
Power LED Rubina (TL400) Foot Switch (UF101) Fiber Optic Light Cable (495TIP/NCSC/NAC)

Camera Head:
Image1 S 4U Rubina (TH121)

Camera Control Unit (CCU):
Image1 S Connect II (TC201US) Image1 S 4U-Link (TC304US)

KARL STORZ Image1 S CCU
The KARL STORZ IMAGE1 S Camera Control Unit (CCU) is a modular CCU that consists of Image1 S Connect and Connect II modules and the link modules. The Connect modules can be connected to minimum of one and a maximum of three links modules. The modularity enables customers to customize their Image1 S system to their specific video needs.

The Image1 S includes, but not limited to, the following features:
Brightness control Enhancement Control Automatic Light Source Control Shutter Control Image/Video Capture
Seven increments of zoom from 1-2.5x and adaptive zoom
Modules of the Image1 S CCU include: Image1 S Connect (TC200US) Image1 S Connect II (TC201US) Image1 S H3-Link (TC300US) Image1 S X-Link (TC301US) Image1 S D3-Link (TC302US) Image1 S 4U-Link (TC304US)
Accessories to the Image1 S CCU include: Microscope Footswitch (TC019) Image1 S Pilot (TC014) LINK Cable (TC011, TC012)

The provided text describes the regulatory submission for the KARL STORZ ICG Imaging System and KARL STORZ Image 1S Camera Control Unit.

However, the document explicitly states that "Clinical testing was not required to demonstrate substantial equivalence to the predicate devices." This means that the submission does not contain information about a study proving the device meets acceptance criteria based on clinical performance metrics (like sensitivity, specificity, accuracy, or human reader improvement with AI assistance).

The acceptance criteria and performance data mentioned in the document are non-clinical performance data, specifically related to electrical safety, electromagnetic compatibility, and software verification and validation. This type of information is usually presented as compliance with established standards rather than a clinical study with a test set, ground truth, or expert readers.

Therefore, most of the requested information regarding clinical study design (sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, training set details) cannot be extracted from this document because such a clinical study was not required or provided for this specific submission as per the FDA's determination of substantial equivalence to predicate devices (K212695 and K201135).

Here's what can be extracted and inferred from the document:

1. A table of acceptance criteria and the reported device performance

Based on the "Non-Clinical Performance Data" section, the acceptance criteria are compliance with relevant safety and software standards.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable / not provided. The document states "Clinical testing was not required." The "performance data" refers to non-clinical engineering and software testing, which does not involve a "test set" of clinical cases in the sense of imaging data for diagnostic performance evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable / not provided. No clinical ground truth was established from experts as clinical testing was not required.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable / not provided. No clinical ground truth was established, therefore no adjudication method was used for clinical interpretation.

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

• Not applicable / not provided. No MRMC study was performed as clinical testing was not required for this submission. The device is an imaging system, not an AI-based diagnostic aid that would assist human readers in interpretation.

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

• Not applicable / not provided. The device is an imaging system, not a standalone diagnostic algorithm. No such performance study was conducted or required.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable / not provided for clinical performance. For the non-clinical performance data, the "ground truth" or standard was compliance with specified international and FDA-recognized standards for electrical safety, EMC, and software validation.

8. The sample size for the training set

• Not applicable / not provided. As this is an imaging system and not an AI/ML-based diagnostic algorithm, there is no mention of a "training set" of data in the context of machine learning model development. The software testing mentioned refers to standard software verification and validation, not machine learning model training.

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

• Not applicable / not provided. See above.

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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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