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Upon intravenous administration of TRADENAME (ICG drug product), the PINPOINT Endoscopic Fluorescence Imaging System is used with TRADENAME to perform intraoperative fluorescence angiography, and it is also indicated for use in fluorescence imaging of biliary ducts, and when intraoperative cholangiography.

The PINPOINT Endoscopic Fluorescence Imaging System is indicated for use to provide real time endoscopic visible and near-infrared fluorescence imaging. The PINPOINT System enables surgeons to perform minimally invasive surgery using standard endoscope 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 or common hepatic duct), using nearinfrared imaging.

Fluorescence imaging of biliary ducts with the PINPOINT 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 of TRADENAME (ICG drug product), the PINPOINT System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic vessels and lymphatic vessels and lymph nodes.

The PINPOINT Endoscopic Fluorescence Imaging System (PINPOINT, PINPOINT System) is comprised of an endoscopic video processor/ illuminator (VPI) which is capable of providing visible and near-infrared illumination to a surgical laparoscope, surgical laparoscopes optimized for visible (VIS) and near-infrared (NIR) illumination and imaging, a camera head that is also optimized for visible and near-infrared imaging, and a flexible light guide cable. The following laparoscope models are included as part of the PINPOINT System: SC9104, SC9134, SC9144, SC9504, SC9534, SC9544, SC9101 and SC9131. These are the major components of the PINPOINT System.

During surgical procedures. PINPOINT may be operated to provide visualization similar to that provided by conventional imaging systems used in surgical endoscopy. The area of interest is illuminated with visible light from the illuminator and the resulting reflected light is imaged by the camera and displayed on the video monitor. When used with the VIS-only laparoscopes, the System is only capable of the conventional mode of visualization described herein.

To provide NIR fluorescence imaging, PINPOINT is used with the imaging agent, indocyanine green (ICG). The patient is injected with ICG imaging agent. The ICG fluoresces when illuminated through the laparoscope with NIR excitation light from the VPI, and the fluorescence response is then imaged with the camera, processed and displayed on an HD video monitor.

When used with a VIS/NIR laparoscope, PINPOINT can operate to provide illumination and imaging of both visible light and ICG fluorescence images simultaneously.

The provided text focuses on the 510(k) submission for the PINPOINT Endoscopic Fluorescence Imaging System, particularly emphasizing its substantial equivalence to a predicate device and expanded indications for use. While it mentions performance testing and a clinical trial, it does not explicitly detail acceptance criteria or the study's findings in a quantitative manner. Therefore, I cannot fully complete the requested table and answer all questions with the provided information.

However, I can extract and infer some information.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, specific quantitative acceptance criteria and detailed performance metrics are not explicitly stated. The submission focuses on demonstrating substantial equivalence.

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

• The text mentions a "Phase III, randomized controlled clinical trial" to support the new lymphatic indications.
• Sample Size: The sample size for this clinical trial is not provided in the given document.
• Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. Given it's a Phase III trial, it would be prospective.

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

• This information is not provided in the document.

4. Adjudication Method for the Test Set

• This information is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• The document mentions a "Phase III, randomized controlled clinical trial" but does not explicitly state if it was an MRMC study or if it measured the comparative effectiveness of human readers with vs. without AI assistance. The device description suggests an imaging system for surgeons, implying human-in-the-loop use, but the study described is for new indications rather than comparative effectiveness for human readers.
• Effect Size: Not provided.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• The PINPOINT Endoscopic Fluorescence Imaging System is described as enabling surgeons to perform minimally invasive surgery and visual assessment. The "device is not intended for standalone use for biliary duct visualization." This strongly suggests the device is an assistive tool for human use, not a standalone AI algorithm. Therefore, a standalone performance study without human-in-the-loop is unlikely for the core device function, though specific aspects of its internal processing might have been validated. The text does not describe a standalone study for an AI algorithm.

7. Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

• For the "Phase III, randomized controlled clinical trial" supporting the lymphatic indications, the type of ground truth used is not specified. For a clinical trial of this nature, it would typically involve clinical outcomes, pathology/histology, or established clinical standards as ground truth.

8. Sample Size for the Training Set

• The device being cleared is an imaging system, not an AI algorithm that would typically require a training set in the conventional sense (e.g., for machine learning model development). While the system likely has internal algorithms for image processing, the submission focuses on its hardware and its use with an imaging agent.
• If "training set" refers to data used to develop any internal algorithms, this information is not provided. The text emphasizes substantial equivalence to a predicate device, implying similar underlying technology.

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

• As the device is an imaging system and not explicitly an AI/ML product developed with a training set for a specific diagnostic task, this information is not applicable or provided in the context of this 510(k) summary.

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The PINPOINT Endoscopic Fluorescence Imaging System is indicated for use to provide real time endoscopic visible and near-infrared fluorescence imaging.

The PINPOINT System enables surgeons to perform minimally invasive surgery using standard endoscope 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 or common hepatic duct), using near-infrared imaging.

Fluorescence imaging of biliary ducts with the PINPOINT 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 PINPOINT Endoscopic Fluorescence Imaging System (PINPOINT, PINPOINT System) is comprised of an endoscopic video processor/ illuminator (VPI) which is capable of providing visible and near-infrared illumination to a surgical laparoscope, surgical laparoscopes optimized for visible (VIS) and near-infrared (NIR) illumination and imaging, a camera head that is also optimized for visible and near-infrared imaging, and a flexible light quide cable. The following laparoscope models are included as part of the PINPOINT System: SC9100, SC9104, SC9130, SC9131, SC9134, SC9144, SC9504, SC9534 and SC9544. These are the major components of the PINPOINT System.

During surgical procedures, PINPOINT may be operated to provide visualization similar to that provided by conventional imaging systems used in surgical endoscopy. The area of interest is illuminated with visible light from the illuminator and the resulting reflected light is imaged by the camera and displayed on the video monitor. When used with the VIS-only laparoscopes, the System is only capable of the conventional mode of visualization described herein.

To provide NIR fluorescence imaging, PINPOINT is used with the imaging agent, indocvanine green (ICG). The patient is injected with ICG imaging agent. The ICG fluoresces when illuminated through the laparoscope with NIR excitation light from the VPI, and the fluorescence response is then imaged with the camera, processed and displayed on an HD video monitor.

When used with a VIS/NIR laparoscope, PINPOINT can operate to provide illumination and imaging of both visible light and ICG fluorescence images simultaneously.

The provided text does not contain detailed information about specific acceptance criteria or a dedicated study proving the device meets these criteria in the format requested. The document is a 510(k) summary for the PINPOINT Endoscopic Fluorescence Imaging System, which primarily focuses on demonstrating substantial equivalence to a predicate device.

However, based on the non-clinical performance testing section, we can infer some general acceptance criteria related to safety and performance through adherence to standards.

Here's an attempt to extract and present the information, acknowledging the limitations of the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the study proving the device meets acceptance criteria:

The document describes "Non-Clinical Performance Testing" which includes adherence to various IEC standards and animal testing. This is the "study" demonstrating performance against safety and basic functional criteria. However, it's not a typical clinical study with patient outcomes or a reader study.

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

• Test Set Sample Size:
  • For the in vivo fluorescence imaging capability, the "test set" was a porcine model. The exact number of animals is not specified.
  • For the other performance tests (IEC standards), these are typically performed on hardware and software and do not involve a "test set" in the sense of patient data.
• Data Provenance:
  • The animal testing (porcine model) appears to be prospective and conducted by NOVADAQ.
  • The standards conformance testing was conducted by NOVADAQ and accredited third-party laboratories.

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

• This information is not provided in the document. The animal model study used to validate in vivo fluorescence imaging would likely have involved veterinarians or surgical experts, but their number and qualifications are not detailed. For the standards testing, "ground truth" is typically defined by the standard itself rather than expert consensus on a test set.

4. Adjudication Method for the Test Set

• This information is not provided. Given the nature of the tests described (animal model and standards conformance), a formal adjudication method like 2+1 or 3+1 is unlikely to have been used, as these are typically reserved for image interpretation studies.

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 comparative effectiveness study is mentioned. This device is an imaging system, not an AI-powered diagnostic tool, so such a study would not be directly applicable in the sense of "human readers improve with AI." The document focuses on the system's ability to provide visual assessment of vessels, blood flow, and bile ducts using near-infrared imaging alongside visible light.

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

• This device is an imaging system used in real-time by surgeons; it is not an algorithm that performs a standalone diagnostic function. Therefore, a standalone algorithm performance study is not applicable and not mentioned. The device's "performance" is its ability to acquire and display images.

7. The type of ground truth used

• For the in vivo fluorescence imaging validation, the ground truth was likely physiological observation within the porcine model by trained personnel, confirming the system's ability to visualize expected fluorescence in living tissue after ICG administration.
• For the standards conformance tests, the "ground truth" is the requirements outlined in the respective IEC and UL standards.

8. The sample size for the training set

• This device is an imaging system, not a machine learning algorithm that requires a "training set" in the conventional sense. Therefore, information about a training set sample size is not applicable and not provided.

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

• As there is no mention of a training set, this information is not applicable.

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The PINPOINT Endoscopic Fluorescence Imaging System is indicated for use to provide real time endoscopic visible and near-infrared fluorescence imaging.

The PINPOINT System enables surgeons to perform minimally invasive surgery using standard endoscope 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 or common hepatic duct), using near-infrared imaging.

Fluorescence imaging of biliary ducts with the PINPOINT 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 PINPOINT Endoscopic Fluorescence Imaging System (PINPOINT, PINPOINT System) is comprised of an endoscopic video processor/ illuminator (VPI) which is capable of providing visible and near-infrared illumination to a surgical laparoscope, surgical laparoscopes optimized for visible (VIS) and near-infrared (NIR) illumination and imaging, a camera head that is also optimized for visible and near-infrared imaging, and a flexible light guide cable. The following laparoscope models are included as part of the PINPOINT System: SC9100, SC9104, SC9130, SC9131, SC9134 and SC9144. These are the major components of the PINPOINT System.

During surgical procedures, PINPOINT may be operated to provide visualization similar to that provided by conventional imaging systems used in surgical endoscopy. The area of interest is illuminated with visible light from the illuminator and the resulting reflected light is imaged by the camera and displayed on the video monitor. When used with the VIS-only laparoscopes, the System is only capable of the conventional mode of visualization described herein.

To provide NIR fluorescence imaging, PINPOINT is used with the imaging agent, indocyanine green (ICG). The patient is injected with ICG imaging agent. The ICG fluoresces when illuminated through the laparoscope with NIR excitation light from the VPI, and the fluorescence response is then imaged with the camera, processed and displayed on an HD video monitor.

When used with a VIS/NIR laparoscope, PINPOINT can operate to provide illumination and imaging of both visible light and ICG fluorescence images simultaneously.

The provided text includes a 510(k) summary for the PINPOINT Endoscopic Fluorescence Imaging System, which describes performance data. However, it does not include specific acceptance criteria or a detailed study proving the device meets those criteria in the format requested.

Here's what can be extracted and what information is missing based on your request:

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

• Acceptance Criteria: Not explicitly stated in the document. The document primarily focuses on demonstrating substantial equivalence to predicate devices and conformance to general safety and performance standards.
• Reported Device Performance:
  • Non-Clinical Performance:
    • Conforms to IEC 60601-1:2012 (Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance).
    • Conforms to IEC 60601-1-2:2007 (Electromagnetic compatibility).
    • Conforms to IEC 60601-2-18:2009 (Particular requirements for the basic safety and essential performance of endoscopic equipment).
    • Assessed as a Class 3R laser device with internal maximum Class 4 laser radiation according to IEC 60825:2007.
    • Animal testing (porcine model) validated in vivo fluorescence imaging capability.
  • Clinical Performance:
    • Clinical evaluation based on literature search and post-market surveillance adverse event information found continued clinical safety and performance.
    • Clinical study and case reports (Journal of Gastrointestinal Surgery, Surgical Innovation, Int! J Sur Case Reports) using the PINPOINT System support expanded Indications for Use.
    • No new concerns related to safety and effectiveness were introduced.

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

• Sample Size for Test Set: Not specified for clinical studies in this document. Animal testing used a "porcine model" (singular, but likely implying multiple animals or instances).
• Data Provenance:
  • Non-Clinical: Novadaq Technologies Inc. and accredited third-party laboratories.
  • Clinical: Clinical literature search, post-market surveillance (adverse event information), a clinical study, and case reports published in medical journals. The country of origin for the clinical data is not specified. It is likely retrospective for the literature review and post-market surveillance, and potentially prospective for the mentioned "clinical study," but this is not explicitly stated.

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

• Not specified. The document refers to clinical studies and case reports, which would typically involve medical experts, but details about ground truth establishment and expert qualifications are absent.

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

• Not specified.

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 mentioned. This device appears to be an imaging system intended for direct visualization by surgeons, not an AI-assisted diagnostic tool for interpretation by readers. The document highlights its use "to provide real time endoscopic visible and near-infrared fluorescence imaging" and "enables surgeons to perform minimally invasive surgery" and "visual assessment."

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

• Not applicable. This is an imaging system for direct surgeon use, not an algorithm. The "device is not intended for standalone use for biliary duct visualization" refers to its use in conjunction with white light and cholangiography, not to an algorithm's standalone performance.

7. The type of ground truth used

• Animal Testing: "In vivo fluorescence imaging capability" validated in a porcine model. This implies comparison against expected fluorescence patterns.
• Clinical Evaluation: Clinical literature and adverse event information. For the clinical study and case reports, the ground truth would typically be surgical outcomes, direct visualization during surgery, or other clinical assessments, but this is not explicitly detailed.

8. The sample size for the training set

• Not applicable as this is not an AI/machine learning device with a distinct training set. The device was "designed and developed."

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

• Not applicable (see above).

Summary of Missing Information:

The provided text is a 510(k) summary demonstrating substantial equivalence to predicate devices and conformance to general safety and performance standards. It lacks the detailed specifications of acceptance criteria, specific clinical study designs (e.g., sample sizes, ground truth establishment methods, expert qualifications, adjudication, MRMC studies) that would be present for a novel AI/algorithm-based diagnostic device. The performance data presented focuses on regulatory compliance, technological characteristics, and general safety/performance based on existing literature and animal models, rather than detailed quantitative performance metrics from controlled clinical trials against specific acceptance criteria.

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