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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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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.

Ask a specific question about this device

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 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.

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 Imaging System includes the following components: 4mm, 5mm & 10mm HOPKINS ICG/NIR Endoscopes, VITOM II ICG Telescope, Image1 S Rubina Camera head, Power LED Rubina light source, footswitch, Fiber Light Cables, Image1 S CCU.

The expanded indication for visualization of the lymphatic vessel is only to the Endoscopic ICG system that includes the 4mm, 5mm & 10mm HOPKINS ICG/NIR Endoscopes.

The addition of the reprocessing modalities is to the 4mm, 5mm & 10mm HOPKINS ICG/NIR Endoscopes and the VITOM II ICG/NIR telescope.

The endoscopes/telescope are intended to be connected to the optical coupler of the camera head, which connects to the CCU for image processing, as well as to the light source via compatible light cable as the source of illumination to allow visualization of internal anatomy. The users can switch between WLi (standard white light) mode, for visualization of the endoscopic and microscopic procedures and NIR (Near Infrared) mode to detect ICG presence.

The KARL STORZ ICG Imaging System can be used with any medical grade monitor with a DVI-D or 12G/3G-SDI input.

The provided text describes a 510(k) submission for the KARL STORZ ICG Imaging System (K202925). It outlines the device's intended use and compares it to predicate devices to establish substantial equivalence. However, this document does not contain information about acceptance criteria, clinical study results, sample sizes for training or test sets, number/qualifications of experts, adjudication methods, MRMC studies, or standalone algorithm performance.

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 substantial equivalence of the expanded indications." This indicates that the regulatory clearance for this device was based on non-clinical data and comparison to existing predicate devices, rather than a clinical study with detailed performance metrics against predefined acceptance criteria for AI/ML performance.

Therefore, I cannot provide the requested information about acceptance criteria and study proving device performance as it is not present in the provided text.

To answer your request precisely, based on the provided document, the following information is NOT available:

1. A table of acceptance criteria and the reported device performance: Not provided. The submission relies on substantial equivalence to predicates based on non-clinical data.
2. Sample sizes used for the test set and the data provenance: Not provided, as clinical testing was not performed for this clearance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided, as clinical testing and ground truth establishment for AI/ML performance are not detailed.
4. Adjudication method for the test set: Not provided.
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 provided. The submission focuses on the imaging system itself, not an AI component assisting human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not provided. The device is an imaging system, not an AI algorithm with standalone performance metrics mentioned.
7. The type of ground truth used: Not provided.
8. The sample size for the training set: Not provided.
9. How the ground truth for the training set was established: Not provided.

Ask a specific question about this device

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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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, and 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.

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 telescope images of visible (VIS) and near-infrared (NIR) indocyanine green (ICG) dye fluorescence during minimally invasive surgery as well as plastic, micro- and reconstructive surgical procedures.

The overall system includes a 5mm &10mm HOPKINS ICG/NIR Endoscope 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 KARL STORZ ICG Kit. Additional accessories used with the KARL STORZ ICG Imaging System include two standard fiber-optic light cables for transmission of VIS and NIR light and the Image1S 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 document is a 510(k) summary for the KARL STORZ ICG Imaging System. It describes the device, its intended use, and argues for its substantial equivalence to a predicate device. However, this document does not contain information about acceptance criteria or a study that proves the device meets specific performance acceptance criteria in the context of diagnostic accuracy or a similar measure typically associated with AI/algorithm performance.

The document states:

• "Clinical testing was not required to demonstrate the substantial equivalence to the predicate devices. Non-clinical bench testing was sufficient to assess safety and effectiveness and to establish the substantial equivalence of the modifications."
• "Additional bench testing was performed to ensure the device met its design specifications."
• "The bench testing performed verified and validated that the KARL STORZ ICG Imaging System has met all its design specification and is substantially equivalent to its predicate devices."

This indicates that the device's approval was based on demonstrating safety, effectiveness, and substantial equivalence to existing devices through non-clinical (bench) testing, primarily focusing on aspects like electrical safety, electromagnetic compatibility, biocompatibility, and mechanical properties, not on diagnostic performance against ground truth in a clinical setting.

Therefore, I cannot provide the requested information for acceptance criteria and a study proving device performance in the context of diagnostic accuracy, as this type of information is not present in the provided text.

Based on the nature of the device (an imaging system for real-time visible and near-infrared fluorescence imaging) and the approval process described, it is highly probable that the "acceptance criteria" referred to in the document pertain to technical specifications, safety standards, and functional performance benchmarks rather than clinical diagnostic accuracy metrics (like sensitivity, specificity, or AUC).

If this were a typical AI/algorithm-based diagnostic device, the requested information would be crucial. However, for a medical imaging system like this, the focus is often on its ability to produce clear, reliable images and its safety for patient use, with appropriate regulatory standards and bench testing serving as the "proof."

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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, 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.

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.

The KARL STORZ ICG Imaging System is used to provide real-time high definition (HD) endoscopic or telescope images of visible (VIS) and near-infrared (NIR) indocyanine green (ICG) dye fluorescence during minimally invasive or open surgery. The system components are a HOPKINS ICG/NIR Endoscope and a VITOM II ICG/NIR Telescope 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 KARL STORZ ICG Kit. Additional accessories used with the KARL STORZ ICG Imaging System include a standard fiber-optic light cable for transmission of VIS and NIR light and the Image1S Camera Control Unit (CCU). All components except for the VITOM II ICG/NIR Telescope were cleared in K152583. The KARL STORZ ICG Imaging System can be used with any medical grade HD monitor with a DVI-D or 3G-SDI input. The VITOM II ICG/NIR Telescope is a Class I device under 21 CFR 878.4700.

The provided text describes a 510(k) submission for the "KARL STORZ ICG Imaging System". This document focuses on demonstrating the substantial equivalence of the new device to previously cleared predicate devices, rather than proving that the device meets specific acceptance criteria through a standalone clinical or "algorithm only" study. Therefore, much of the requested information about acceptance criteria, detailed study design, ground truth establishment, and multi-reader multi-case studies is not present in the provided text.

Specifically, the document states: "Clinical testing was not required to demonstrate the substantial equivalence to the predicate devices. Non-clinical bench testing was sufficient to assess safety and effectiveness and to establish the substantial equivalence of the modifications."

This indicates that the submission relies on demonstrating comparable performance to predicate devices through non-clinical (bench and animal) testing, rather than establishing specific performance metrics against a predefined acceptance criterion in human clinical data.

However, I can extract information about the non-clinical testing performed and how it aims to demonstrate equivalence, which implicitly serves as the "study" proving the device's acceptable performance in the context of this 510(k).

Here's the information based on the provided text:

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

The document does not explicitly state quantitative "acceptance criteria" in the format of a table with specific metrics (e.g., minimum sensitivity, maximum false positive rate). Instead, the performance is demonstrated by showing that the new system is "as safe as and as effective as" the predicate devices in various non-clinical tests. The reported 'performance' is qualitative: the system "successfully tested for its functions and performance" and "enable a selective visualization of the ICG fluorescence signal."

While specific quantitative results are not provided, the conclusion states that these tests "demonstrated that the subject device is as safe as and as effective as the primary predicate device," implying satisfactory performance on these aspects. |
| Biocompatibility | Should not change from the previously cleared system. | "The addition of the VITOM II ICG Telescope to the system does not change the biocompatibility... conducted for the KARL STORZ Endoscopic ICG System cleared in K152583." |
| Electromagnetic Compatibility (EMC) | Should not change from the previously cleared system. | "The addition of the VITOM II ICG Telescope to the system does not change the ... electromagnetic compatibility... conducted for the KARL STORZ Endoscopic ICG System cleared in K152583." |
| Electrical Safety | Should not change from the previously cleared system. | "The addition of the VITOM II ICG Telescope to the system does not change the ... electrical safety... conducted for the KARL STORZ Endoscopic ICG System cleared in K152583." |
| Software Validations | Should not change from the previously cleared system. | "The addition of the VITOM II ICG Telescope to the system does not change the ... software validations conducted for the KARL STORZ Endoscopic ICG System cleared in K152583." |
| Cleaning & Sterilization | Validation for the new component (VITOM II ICG Telescope) is required. | "Cleaning method validation and sterilization validation were performed on the VITOM II ICG Telescope." |
| Animal Study Performance | Performance in animal model should be adequate for evaluation. | "a GLP animal study was successfully performed by the NAMSA testing facility to evaluate the performance of the KARL STORZ ICG Imaging System with the VITOM II ICG Telescope in the porcine open surgery laparoscopy model." |
| Compliance with Standards | Device must meet relevant safety standards. | The device (and its predicates) are listed as meeting IEC 60601-1-2 and IEC 60601-1. The Visionsense predicate also met IEC 60825-1. "Bench testing was performed per IEC 62471." |

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

• Sample Size: Not explicitly stated with numerical values. The document refers to "comparative testing" and a "GLP animal study" without specifying the number of samples or animals used.
• Data Provenance:
  • Bench Testing: Conducted in-house or by testing laboratories (e.g., "NAMSA testing facility"). The country of origin is not specified but implied to be within the scope of FDA regulations (likely USA or a country with recognized testing standards).
  • Animal Study: Performed by "NAMSA testing facility" using a "porcine open surgery laparoscopy model."
  • Retrospective/Prospective: All described tests are non-clinical and would be conducted prospectively as part of the device development and submission process.

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

Not applicable. This was a non-clinical study for substantial equivalence. The "ground truth" was based on the physical and optical properties of the device and its ability to visualize ICG fluorescence as measured by established testing methods and verified by the testing facility. There's no mention of human experts establishing "ground truth" in the diagnostic sense for a test set.

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

Not applicable. This was a non-clinical study. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in clinical imaging studies involving multiple human readers.

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. No MRMC study was performed as this was a 510(k) submission based on non-clinical substantial equivalence. The device is an imaging system, not an AI-powered diagnostic tool, and the submission explicitly states "Clinical testing was not required."

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

This concept doesn't directly apply here. The device itself is an integrated imaging system (camera, endoscope/telescope, light source). Its "standalone performance" is demonstrated through its physical and optical characteristics (e.g., light transmission, spectral characteristics, visualization of ICG signal) as measured in bench and animal studies, rather than an "algorithm."

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

The "ground truth" for the non-clinical tests would have been based on:

• Physical measurements and optical properties: For tests like "spectral characteristics," "irradiance levels," and "depth dependency," the ground truth is derived from established physics principles and calibrated measurement equipment.
• Known ICG fluorescence: For "visualization of ICG signal," the ground truth is the known presence and location of the fluorescent dye.
• Biological outcomes (animal model): In the GLP animal study, the "performance" would have been evaluated based on the ability of the system to correctly visualize blood flow/perfusion and biliary ducts as expected in the porcine model, potentially against direct observation or other validated methods if used in the study.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a "training set."

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

Not applicable, as this is not an AI/machine learning device.

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