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Telescopes for adults
KARL STORZ HOPKINS Telescopes for Urology when used with sheaths, obturators, accessories, and instruments are intended to provide visualization and operative access during diagnostic and therapeutic urological procedures in adults.

Telescopes for adults and pediatrics
KARL STORZ HOPKINS Telescopes for Urology when used with sheaths, obturators, accessories, and instruments are intended to provide visualization and operative access during diagnostic and therapeutic urological procedures in adults and pediatrics.

The KARL STORZ HOPKINS Telescopes for Urology are rigid cystoscope systems, which provide visualization and operative access during urological procedures in adults and pediatrics. Urological devices consist of sheaths, obturators, accessories, and instruments, which are combined into a cystoscope system for diagnostic or therapeutic procedures in the lower urinary tract such as prostate, bladder, and urethra. The sheath provides a working channel for therapeutic instruments, as well as ports for irrigation and aspiration. The obturator is inserted through the sheath for atraumatic insertion to the surgical site, then removed after placement. The telescope is inserted through the sheath for visualization of the surgical site. All instruments subject to this submission are optical instruments, and compatible with telescopes; the optical instruments are only compatible with adult systems. Compact telescopes are all-in-one cystoscopes with built-in sheaths, obturators, and optics, they do not require device compilation for use.

The provided text is an FDA 510(k) clearance letter and its accompanying summary for the KARL STORZ HOPKINS Telescopes for Urology. This document details the regulatory pathway for a medical device, specifically rigid endoscopes, not an AI software or system. Therefore, most of the questions regarding acceptance criteria and study design for AI performance are not applicable.

Here's an analysis of the provided information:

Analysis of Acceptance Criteria and Study for a Medical Device (Endoscope):

Given that this is a medical device (endoscope), the "acceptance criteria" are typically related to meeting established performance standards for such devices. The "study" refers to non-clinical bench testing to demonstrate compliance with these standards and substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a formal table of acceptance criteria with specific numerical performance targets and reported values in the way you might see for an AI algorithm's accuracy or sensitivity/specificity. Instead, the acceptance criteria are implicit in the adherence to international and national standards for medical devices, particularly endoscopes. The reported device performance is that it complies with these standards.

2. Sample Size for the Test Set and Data Provenance:

• Sample Size: Not applicable in the context of an endoscope's non-clinical bench testing. The "test set" here refers to the actual device prototypes or representative samples tested in a laboratory setting to verify compliance with engineering and safety standards. The number of units tested isn't specified but typically involves a sufficient number to ensure reproducibility and meet statistical requirements for the specific test (e.g., several samples for biocompatibility, multiple cycles for reprocessing).
• Data Provenance: The testing is non-clinical bench testing, meaning it does not involve human subjects or real-world patient data. It is performed in a controlled laboratory environment by the manufacturer (KARL STORZ SE & Co. KG), likely in Germany given their address.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

• Experts for Ground Truth: Not applicable. For a rigid endoscope, "ground truth" is defined by established engineering specifications and compliance with recognized national and international standards. The "truth" is whether the device performs according to these measurable standards, not a subjective interpretation by experts.
• Qualifications of Experts: Not applicable. The "experts" involved are likely engineers, quality assurance personnel, and regulatory specialists within Karl Storz and external testing laboratories who are qualified to conduct and interpret the specified tests according to the standards.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations (e.g., in medical image diagnosis). For physical device testing, the results are typically quantitative measurements that either pass or fail against predefined criteria in the standards.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:

• MRMC Study: No. MRMC studies are used to evaluate the impact of a new diagnostic aid (like an AI system) on human reader performance across multiple readers and cases. This is not relevant for a rigid endoscope, which is a physical visualization and access tool.

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

• Standalone Performance: Not applicable. This device is a physical endoscope, not an AI algorithm. Its function is to provide visualization, which inherently involves a human user (the clinician) in the loop.

7. The type of ground truth used:

• Type of Ground Truth: The "ground truth" is adherence to established engineering specifications, safety standards (e.g., thermal safety), optical performance metrics (e.g., field of view, resolution), biocompatibility requirements, and validated reprocessing protocols as defined by the numerous ISO, IEC, AAMI, ASTM, and ANSI standards listed. It is a technical and regulatory compliance "ground truth."

8. The sample size for the training set:

• Training Set Sample Size: Not applicable. This is a physical medical device, not an AI algorithm that undergoes training.

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

• Training Set Ground Truth: Not applicable. As this is not an AI device, there is no "training set" or "ground truth for the training set."

In summary, the provided document is a regulatory submission for a physical medical device (an endoscope) and not for an AI/software device. Therefore, the specific questions related to AI performance metrics, sample sizes for AI training/test sets, expert adjudication, and MRMC studies are not applicable to this submission. The "acceptance criteria" are demonstrated through non-clinical bench testing proving compliance with relevant industry standards and substantial equivalence to a predicate device.

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The KARL STORZ Flexible Video-Uretero-Renoscope is indicated for endoscopic examination in the urinary tract and can be used to examine the interior of the kidney, and using additional accessories, to perform various diagnostic and therapeutic procedures.

The KARL STORZ Flexible Video-Uretero-Renoscope (PNs 11278VSE, 11278VSUE) is a video endoscope used for visualization within the upper urinary tract (ureters) and kidneys. The endoscope includes a luer with two ports to allow access for instrumentation, as well as irrigation. The Flexible Video-Uretero-Renoscope models 11278VSE and 11278VSUE differ only in the direction of the distal tip deflection. With 11278VSUE when the control lever is pushed forward towards the distal tip, the distal tip deflects down and with 11278VSE the deflection is opposite.

The provided FDA 510(k) clearance letter and summary describe a medical device (FLEX XC ureteroscope), not an AI or software-based medical device. Therefore, the information requested about acceptance criteria and studies that apply to AI/Software as a Medical Device (SaMD) are not present in this document.

The clearance is based on the substantial equivalence of the KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC) to a previously cleared predicate device (K141250 KARL STORZ Flexible Video-Uretero-Renoscope).

Here's an analysis of the provided information concerning the device's performance, but it does not include any of the AI/SaMD specific criteria you requested as the device is a physical endoscope.

Device: KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC)
Product Code: FGB
Regulatory Class: Class II

Acceptance Criteria and Reported Device Performance (Non-AI/SaMD)

Since this is a physical medical device (endoscope), the "acceptance criteria" primarily relate to its physical and functional specifications, and its compliance with relevant performance and safety standards.

Note on Differences: The subject device (FLEX XC) shows an improved deflection range (285° up/down vs. 270°) and a potentially wider field of view range (80-110° vs. 80-95°) compared to the predicate. The submission argues these differences do not raise new questions of safety and effectiveness, supported by non-clinical bench testing.

Study Details (Based on provided document)

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

Therefore, the following information, which is typically relevant for AI/SaMD clinical validation studies, is not applicable or not provided in this document:

1. Sample sizes used for the test set and the data provenance: Not applicable, as no clinical test set for AI/SaMD performance was used. The reported "performance" comes from bench testing of the physical device.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for AI/SaMD performance was not established.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable. This is a physical device, not an AI-assisted diagnostic tool.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this medical device is its compliance with recognized performance standards and its physical and functional characteristics being comparable (or superior, without raising new concerns) to a cleared predicate.
7. The sample size for the training set: Not applicable. This 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.

Conclusion: The provided FDA 510(k) clearance documentation for the KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC) pertains to a traditional physical medical device, not a software-as-a-medical-device (SaMD) or AI-enabled device. The clearance is based on a demonstration of substantial equivalence to a predicate device through non-clinical bench testing, not through clinical studies involving human readers or AI algorithm performance analysis. Therefore, the specific criteria and study details related to AI/SaMD validation are absent from this document.

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The KARL STORZ Cysto-Urethro-Fiberscope and accessories are indicated for visualization and operative access during diagnostic and therapeutic endoscopic procedures of the urinary tract including the urethra and bladder.

The KARL STORZ Cysto-Urethro-Fiberscope and Accessories consists of a flexible fiber endoscope (Model Number: 11272CU1 / 11272C2) which can be used standalone or connected to compatible FDA-cleared camera heads which transfer images to compatible FDA-cleared Computer Control Units (CCUs) for the purposes of visualization and operative access during diagnostic and therapeutic endoscopic procedures of the urinary tract including the urethra and bladder.

Based on the provided FDA 510(k) clearance letter for the KARL STORZ Cysto-Urethro-Fiberscope, it's clear that no clinical performance data was provided or required for this 510(k) submission. The submission relies entirely on non-clinical (bench) performance data.

Therefore, many of the requested elements pertaining to acceptance criteria and clinical study design (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth types for clinical data) are not applicable to this particular device clearance.

The 510(k) summary explicitly states:

Clinical Performance Data Clinical testing was not required to demonstrate substantial equivalence to the predicate device. Non-clinical bench testing was sufficient to assess safety and effectiveness and to support substantial equivalence.

Given this, I will describe the acceptance criteria as implied by the non-clinical tests conducted and the proof that the device met these criteria based on the information provided.

Acceptance Criteria and Study Proving Device Meets Acceptance Criteria for KARL STORZ Cysto-Urethro-Fiberscope

As per the submitted 510(k) summary (K244001), the substantial equivalence of the KARL STORZ Cysto-Urethro-Fiberscope was established through non-clinical performance data only. No clinical studies were conducted or required for this clearance.

Therefore, the "acceptance criteria" are derived from the successful completion of various bench tests and compliance with recognized standards designed to ensure the safety and effectiveness of the device. The "study" proving the device meets these criteria refers to the non-clinical (bench) performance testing.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are implicitly tied to the successful completion and passing results of the tests conducted in accordance with the listed standards and internal design specifications. The performance is reported as meeting these standards.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: Not applicable. No clinical test set was used. The "test set" in this context refers to the physical units of the device subjected to bench testing. The specific number of units tested for each non-clinical performance test is not detailed in the 510(k) summary, but it would have been sufficient to meet the requirements of the cited standards and internal quality procedures.
• Data Provenance: Not applicable for a clinical study. The non-clinical testing was conducted by KARL STORZ SE & CO. KG, which is based in Tuttlingen, Germany. The data is from laboratory (bench) testing, not patient data.

3. Number of Experts Used to Establish Ground Truth for Test Set and Qualifications

Not applicable. No clinical test set requiring expert ground truth establishment was used. Bench testing relies on objective measurement against predefined specifications and standard requirements, not subjective expert assessment of clinical data.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set requiring adjudication was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. An MRMC study was not conducted as no clinical performance study was performed or required.

6. If a Standalone Performance Study (Algorithm Only) Was Done

Not applicable. This device is a medical instrument (fiberscope), not an AI algorithm. Therefore, a standalone algorithm performance study is irrelevant.

7. The Type of Ground Truth Used

• For Non-Clinical Testing: The "ground truth" for the bench tests is the objective, measurable performance of the device against established engineering specifications, safety standards (e.g., IEC, ISO, ANSI/AAMI), and the functional capabilities of the predicate device. This is determined through physical measurements, chemical analyses, and standardized test protocols.

8. The Sample Size for the Training Set

Not applicable. No clinical training set was used as this is a physical medical device (fiberscope), not an AI/ML algorithm requiring data-driven training.

9. How the Ground Truth for the Training Set Was Established

Not applicable. No clinical training set was used.

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The KARL STORZ Pediatric Cysto-Urethro-Fiberscope and accessories are intended for use by a physician in the visual examination and treatment of a variety of urological endoscopic procedures for pediatric patients.

The KARL STORZ Pediatric Cysto-Urethro-Fiberscope and Accessories consists of a flexible fiber endoscope (Model Number: 11274BCU1) which can be used standalone or connected to compatible FDA-cleared camera heads which transfer images to compatible FDA-cleared Computer Control Units (CCUs) for the purposes of visual examination and treatment of a variety of urological endoscopic procedures for pediatric patients.

The provided text is a 510(k) Summary for the KARL STORZ Pediatric Cysto-Urethro-Fiberscope. It outlines the characteristics of the device and establishes its substantial equivalence to a predicate device. However, it does not contain acceptance criteria or a study that proves the device meets specific performance criteria in the context of AI/ML or diagnostic accuracy.

The document details non-clinical performance data, primarily focusing on compliance with various international standards for biocompatibility, reprocessing validation, and bench performance testing for mechanical, optical, and thermal/photobiological safety.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance related to diagnostic accuracy or AI/ML.
2. Sample size and data provenance for a test set (as no such test set for diagnostic performance is described).
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone (algorithm only) performance.
7. Type of ground truth (as no ground truth for diagnostic performance is mentioned).
8. Sample size for the training set.
9. Ground truth establishment for the training set.

The document explicitly states: "Clinical testing was not required to demonstrate the substantial equivalence to the predicate device." This confirms that there was no study conducted to assess the device's diagnostic performance against specific acceptance criteria using patient data, which is what your questions are geared towards.

The "Non-Clinical Performance Data" section lists various standards the device complies with, but these are related to the physical and functional safety of the endoscope itself, for example:

• Biocompatibility Testing: ISO 10993 series for biological evaluation of medical devices.
• Reprocessing Validation: Standards like ISO 14937, ISO 17665-1, AAMI ST98 for cleaning and sterilization.
• Bench Performance Testing: IEC 60601-2-18, IEC 62471, ISO 8600-3, ISO 8600-5 for mechanical, optical, and thermal/photobiological performance.

These are not acceptance criteria or performance metrics related to diagnostic accuracy or the performance of an AI/ML component. The device is a flexible fiber endoscope, and the regulatory filing focuses on its substantial equivalence to another endoscope based on engineering specifications and safety standards, rather than any AI-driven diagnostic capabilities.

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The KARL STORZ Pediatric Cysto-Urethro-Fiberscope and accessories are intended for use by a physician in the visual examination and treatment of a variety of urological endoscopic procedures for pediatric patients.

The KARL STORZ Pediatric Cysto-Urethro-Fiberscope and Accessories consists of a flexible fiber endoscope (Model Numbers: 11278ACU1 and 11278AC2) which can be used standalone or connected to compatible FDA-cleared camera heads which transfer images to compatible FDA-cleared Computer Control Units (CCUs) for the purposes of visual examination and treatment of a variety of urological endoscopic procedures for pediatric patients.

The provided document is an FDA 510(k) clearance letter for the KARL STORZ Ped. Cysto-Urethro-Fiberscope. This type of document declares substantial equivalence to a predicate device, meaning it is similar enough to an existing marketed device that it does not require new efficacy studies or clinical trials for approval.

Therefore, the document explicitly states:

• "Non-Clinical performance data is not provided in this submission as the majority of the technological characteristics of the subject device and predicate device are equivalent. Where differences exist, the results of testing on the reference device are leveraged in support of safety and effectiveness."
• "Clinical testing was not required to demonstrate the substantial equivalence to the predicate device."

This means that the information requested regarding acceptance criteria, performance studies, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth for the training set are not part of this 510(k) submission and are not present in the provided text. The clearance is based on the device's technological similarity to previously cleared devices, not on new performance studies as would be required for a novel device or a PMA submission.

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Percutaneous System for adults
The KARL STORZ Percutaneous System is intended to be used during percutaneous removal of kidney stones in adults.

Percutaneous System for adults and pediatrics
The KARL STORZ Percutaneous System is intended to be used during percutaneous removal of kidney stones in adults and pediatrics >1month of age.

The Percutaneous Nephroscope System consists of the following:

• Minimally Invasive Percutaneous Nephrolithopaxy (MIP) Nephroscopes
• HOPKINS Telescopes for Percutaneous Nephrolithotomy (PCNL)
• Operating Sheaths
• One-Step Dilators
• Telescope Bougie Set
• Hollow Obturator and Fascial Dilator Applicators
• Biopsy and Grasping forceps
• Scissors
• Knives
• Insertion Aid
• Laser Hand Instrument
• Suction tube
• Adaptors
• Luer-Lock tube connectors

The provided text is a 510(k) summary for the KARL STORZ Percutaneous Nephroscope System. This document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance and a literature review for pediatric use.

Based on the provided text, the sections relating to acceptance criteria and the study that proves the device meets them are primarily about non-clinical bench testing and literature review, as opposed to a complex clinical study for AI or image analysis devices.

Here's a breakdown of the information requested, based only on the provided document:

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

The document states: "Comparative bench testing between the subject and predicate DEVICES demonstrated that the endoscopes in the Percutaneous Nephroscope System meets all its design specification and is substantially equivalent to its predicate device. Additional bench testing was performed for the subject device instruments (forceps and scissors) to ensure the device met its design specifications and is substantially equivalent to the predicate."

However, specific numerical acceptance criteria (e.g., minimum tensile strength, maximum insertion force, specific illumination levels) and the precise reported performance values are not explicitly detailed in this 510(k) summary. The summary only generally states that the device "meets all its design specification."

Therefore, a table of specific acceptance criteria and reported performance cannot be fully constructed from the provided text. The document refers to compliance with ISO and IEC standards, which would imply that the device met the performance requirements outlined in those standards.

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

• Sample size: The document does not specify a "sample size" in the context of clinical testing of humans or images. The "test set" refers to the specific devices and instruments undergoing bench testing. The document implies that sufficient units were tested to demonstrate compliance with design specifications and substantial equivalence, but the exact number of devices tested is not stated.
• Data provenance: The document indicates non-clinical bench testing (likely performed internally by the manufacturer or contracted labs) and a literature review. The provenance of the literature is not specified beyond "Published literature." There is no mention of country of origin for any human data (as no new human clinical studies were performed). The testing is implicitly prospective in the sense that the manufacturer conducted the tests for this submission.

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

This information is not applicable to the data provided. The "ground truth" for this type of device submission (Percutaneous Nephroscope System) is established through engineering and performance specifications validated by bench testing and adherence to recognized standards. There isn't a "test set" of patient images or clinical cases requiring expert interpretation to establish ground truth in the way it would be for an AI diagnostic device. The "ground truth" for the pediatric indication was established through existing published literature, not by new expert consensus specifically for this submission.

4. Adjudication method for the test set

This information is not applicable as there are no human-read test sets requiring adjudication of interpretations. The tests are bench tests proving physical and functional characteristics.

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, an MRMC comparative effectiveness study was not done, and this type of study is not relevant to a Percutaneous Nephroscope System. This device is a surgical instrument, not an AI-assisted diagnostic or image analysis tool.

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

No, this is not applicable. The device is a physical surgical instrument, not an algorithm.

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

For the bench testing, the "ground truth" is based on engineering design specifications, established performance standards (ISO, IEC, AAMI), and the performance of the predicate device. For the pediatric indication, the "ground truth" for safety and effectiveness was established from published literature, which likely includes clinical outcomes data, expert opinions, and various study types from prior research involving similar devices/procedures in pediatrics.

8. The sample size for the training set

This information is not applicable as there is no "training set" in the context of an AI/machine learning model for this device.

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

This information is not applicable as there is no "training set" in the context of an AI/machine learning model for this device.

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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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