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Upon intravenous administration of SPY AGENT™ GREEN (indocyanine green for injection, USP) the SPY-PHI System is used with SPY AGENT™ GREEN to perform intraoperative fluorescence angiography. The SPY-PHI System is indicated for use in adult and pediatric patients one month of age and older.

The SPY-PHI System is indicated for fluorescence imaging of blood flow and tissue perfusion before, during, and after: vascular, gastrointestinal, organ transplant, and plastic, micro- and reconstructive surgical procedures.

Upon interstitial administration of SPY AGENT™ GREEN, the SPY-PHI System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.

The SPY-PHI System is an imaging system used in capturing and viewing fluorescent images for the visual assessment of blood flow, as an adjunctive method for the evaluation of tissue perfusion, and related tissuetransfer circulation for use in imaging during various surgical procedures.

The SPY-PHI System provides real-time, white-light and fluorescence imaging during surgical procedures. The system consists of a SPY-PHI imager/imaging head with an integrated light quide cable and a Video Processor/Illuminator (VPI).

Fluorescence imaging with the SPY-PHI System is achieved with the use of a fluorescence imaging agent, namely SPY AGENT™ GREEN (indocyanine green for injection, USP), which is supplied in single-use convenience kits for use in conjunction with the SPY-PHI System during surgical procedures.

During surgical procedures, SPY AGENT™ GREEN is administered to the patient. The SPY-PHI imaging head/imager provides illumination of the regions of a patient's body to be observed with near infrared (NIR) laser light to excite ICG fluorescence. Alternatively, the SPY-PHI imager provides white light illumination of the regions of a patient's body to be observed for color imaging.

The camera in the Imaging Head captures the fluorescent image under laser illumination or a color image under white light illumination. The VPI receives the video signal from the Imaging Head and processes and outputs the video image to a medical grade video monitor and/or video recorder. Adjustments to the operation of the SPY-PHI System are possible through switches at either the Imaging Head or the VPI. The SPY-PHI System is intended for use by trained healthcare professionals in the operating room.

This Traditional 510(k) premarket notification proposes a modification to the currently 510(k) cleared SPY-PHI System with the addition of a new software feature. The new software feature, referred to as the SPY-PHI Fluorescence Assessment Software, will offer real-time relative fluorescence quantification (i.e. relative fluorescence values) and visualization tools (i.e. color maps) on the SPY-PHI device. Addition of this new software feature has no impact on the current intended use of the SPY-PHI System. The SPY-PHI Fluorescence Assessment Software is a firmware module installed on the VPI component of the SPY-PHI System for use during open field surgery where fluorescence imaging is used.

The SPY-PHI Fluorescence Assessment Software enables quantification of fluorescence which may be used as an additional intraoperative tool to assist trained healthcare practitioners in the assessment of fluorescence response in tissue during various surgical procedures. The healthcare practitioner retains the ultimate responsibility for making the pertinent diagnosis based on their clinical judgment and standard practices.

The provided text describes performance testing for the SPY-PHI System with SPY-PHI Fluorescence Assessment Software, but it does not contain specific acceptance criteria, reported device performance metrics in a table, details of a study proving the device meets acceptance criteria, sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC study information, standalone performance, or training set details.

Therefore, most of the requested information cannot be extracted from the given document.

Here's a summary of what is available regarding performance testing:

Description of Performance Testing:

The SPY-PHI System conducted performance testing through a design validation study for its new Fluorescence Assessment Software feature.

1. A table of acceptance criteria and the reported device performance: This information is not provided in the document. The document states a design validation study was performed to assess suitability to meet user needs, but it does not detail specific acceptance criteria or quantitative performance results.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): This information is not provided in the document.

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): This information is not provided in the document.

4. Adjudication method (e.g. 2+1, 3+1, none) 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, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This information is not provided in the document.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document describes the software as an "additional intraoperative tool to assist trained healthcare practitioners," implying human-in-the-loop. It does not explicitly mention a standalone algorithm-only performance assessment.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): This information is not provided in the document. The study assessed "suitability of the design requirements... to meet user needs," which suggests a qualitative assessment of the software's functionality and utility rather than a direct comparison against a clinical ground truth.

8. The sample size for the training set: This information is not provided in the document.

9. How the ground truth for the training set was established: This information is not provided in the document.

The document primarily focuses on regulatory compliance and substantial equivalence to predicate devices, stating that the device was designed and developed in accordance with applicable requirements and standards, and that its safety and performance were verified through testing, including by accredited third-party laboratories. It also mentions software assessment for conformance with IEC 62304:2015.

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Upon intravenous administration of SPY AGENT™ GREEN (indocyanine green for injection, USP) the SPY-PHI System is used with SPY AGENT™ GREEN to perform intraoperative fluorescence angiography. The SPY-PHI System is indicated for use in adult and pediatric patients one month of age and older.

The SPY-PHI System is indicated for fluorescence imaging of blood flow and tissue perfusion before, during, and after: vascular, gastrointestinal, organ transplant, and plastic, micro- and reconstructive surgical procedures.

Upon interstitial administration of SPY AGENT™ GREEN, the SPY-PHI System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.

The SPY-PHI System is an imaging system used in capturing and viewing fluorescent images for the visual assessment of blood flow, as an adjunctive method for the evaluation of tissue perfusion, and related tissuetransfer circulation for use in imaging during various surgical procedures.

The SPY-PHI System consists of the following main components: Imaging Head/ Imager (HH9030) with an integrated light quide cable and the Video Processor/Illuminator (VPI) (PC9001).

SPY AGENT™ GREEN (indocyanine green for injection, USP) is injected intravenously into the patient. The Imaging Head may be either handheld or attached to a mechanical arm and provides illumination of the regions of a patient's body to be observed with near infrared laser light to excite SPY AGENT™ GREEN fluorescence. Alternatively, the Imaging Head provides white light illumination of the regions of a patient's body to be observed for color imaging.

A CMOS camera in the Imaging Head captures the fluorescent image under laser illumination or a color image under white light illumination. The VPI receives the video signal from the Imaging Head and processes and outputs the video image to a medical grade video monitor and/or video recorder. Adjustments to the operation of the SPY-PHI System are possible through switches at either the Imaging Head or the VPI.

The provided text outlines the general safety and performance testing for the SPY-PHI System but does not contain detailed acceptance criteria or results from a study that specifically proves the device meets those criteria.

Here's an analysis of what is and isn't available in the text, structured as requested:

1. Table of Acceptance Criteria and Reported Device Performance

Not available in the provided text. The document states that "The SPY-PHI System was designed and developed in accordance with the applicable requirements and standards to establish performance and safety of the device's safety and performance were verified, including testing conducted by accredited third-party laboratories." and "A design validation study was conducted to assess the suitability of the design requirements of the SPY-PHI System to meet user needs and evaluated the in vivo fluorescence imaging capability of SPY-PHI for the visualization of the lymphatic system, including lymphatic vessels and lymph nodes." However, it does not provide specific acceptance criteria (e.g., sensitivity, specificity, accuracy targets) or quantitative results (e.g., reported percentages for these metrics).

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

The text mentions a "design validation study" conducted to evaluate "in vivo fluorescence imaging capability."

• Sample Size: Not specified.
• Data Provenance: The study evaluated "in vivo fluorescence imaging capability," implying human or animal subjects. However, the specific country of origin, whether it was retrospective or prospective, or the number of subjects or cases are not detailed.

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

Not available in the provided text. The study is described as evaluating "in vivo fluorescence imaging capability," but there's no mention of how ground truth was established, who the experts were, or their qualifications.

4. Adjudication Method for the Test Set

Not available in the provided text.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not available in the provided text. The document does not describe any study comparing human readers with and without AI assistance, nor does it quantify any effect size of improvement.

6. Standalone (Algorithm Only) Performance Study

Not applicable. The SPY-PHI System is described as an "imaging system" used for "intraoperative fluorescence angiography" and "visualization of the lymphatic system" with "human-in-the-loop performance" (i.e., a surgeon using the device to visualize). It is not an AI algorithm designed to interpret images autonomously. Therefore, a standalone algorithm-only performance study would not be relevant in the context of this device.

7. Type of Ground Truth Used

The text indicates a "design validation study" that "evaluated the in vivo fluorescence imaging capability of SPY-PHI for the visualization of the lymphatic system, including lymphatic vessels and lymph nodes." While "in vivo" implies real-world observation during surgical procedures, the specific type of ground truth (e.g., expert consensus based on visual assessment, pathological confirmation, or outcomes data) is not detailed.

8. Sample Size for the Training Set

Not applicable. The SPY-PHI System is a hardware imaging system, not an AI/ML algorithm that requires a training set.

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

Not applicable. As noted above, this is a hardware imaging system, not an AI/ML algorithm with a training set.

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Upon intravenous administration of SPY AGENT™ GREEN (Indocyanine green for injection, USP) the SPY-PHI System is used with SPY AGENT™ GREEN to perform intraoperative fluorescence angiography. The SPY-PHI System is indicated for use in adult and pediatric patients one month of age and older.

The SPY-PHI System is indicated for fluorescence imaging of blood flow and tissue perfusion before, during, and after: vascular, gastrointestinal, organ transplant, and plastic, micro- and reconstructive surgical procedures.

The SPY-PHI System is an imaging system used in capturing fluorescent images for the visual assessment of blood flow, as an adjunctive method for the evaluation of tissue perfusion, and related tissuetransfer circulation for use in imaging during various surgical procedures.

The SPY-PHI System consists of the following main components: Imaging Head/ Imager (HH9030) with an integrated light guide cable and the Video Processor/Illuminator (VPI) (PC9001).

Indocyanine green (ICG) is injected intravenously into the patient. The Imaging Head may be either handheld or attached to a mechanical arm and provides illumination of the regions of a patient's body to be observed with near infrared laser light to excite ICG fluorescence. Alternatively, the Imaging Head provides white light illumination of the regions of a patient's body to be observed for color imaging.

A CMOS camera in the Imaging Head captures the fluorescent image under laser illumination or a color image under white light illumination. The VPI receives the video signal from the Imaging Head and processes and outputs the video image to a medical grade video monitor and/or video recorder. Adjustments to the operation of the SPY-PHI System are possible through switches at either the Imaging Head or the VPI.

Here's a summary of the acceptance criteria and the study method for the SPY Portable Handheld Imaging (SPY-PHI) System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to predicate devices and expanding indications for use, rather than presenting specific quantitative acceptance criteria or detailed performance metrics in numerical form for the SPY-PHI System itself. The acceptance is based on conformance to established standards and a literature review supporting expanded indications.

2. Sample Size and Data Provenance for Test Set:

• Sample Size: Not explicitly stated as a numerical sample size for a dedicated "test set" in the context of device performance. The evaluation for expanded indications relied on a "series of clinical literature evaluations" and "published literature references."
• Data Provenance: The data provenance for the clinical evaluation component is from published literature. The country of origin for this literature is not specified, but it represents retrospective data gathered from existing studies. The conformance testing for safety and software was conducted by Novadaq and accredited third-party laboratories (provenance not further specified).

3. Number of Experts and Qualifications for Ground Truth of Test Set:

Not applicable. The document does not describe a process for establishing ground truth for a test set using a specific number of experts for interpretation of images or clinical outcomes. The clinical claims were supported by a review of published literature.

4. Adjudication Method for Test Set:

Not applicable. No adjudication method is described as there was no expert review of a dedicated test set within this submission. The clinical summary relies on findings reported in existing published literature.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with AI assistance versus without AI assistance was not reported in this document. The device itself is an imaging system, not an AI-assisted diagnostic tool for interpretation.

6. Standalone (Algorithm Only) Performance Study:

Not applicable. The SPY-PHI System is an imaging system and a drug-device combination product that facilitates the visualization of blood flow. It is not an algorithm-only device where "standalone performance" (without human-in-the-loop) would be typically assessed in the context of diagnostic AI. Its performance is tied to the visualization it provides for human interpretation in a surgical setting.

7. Type of Ground Truth Used:

For the expansion of indications, particularly to pediatric patients, the ground truth was based on:

• Clinical literature evaluations: Efficacy data (successful visualization) and safety data (absence of adverse events) reported in peer-reviewed publications.
• Anecdotal clinical experience: Mentioned for supporting the observation that lower ICG doses may be effective in younger/lower body weight patients.

For conformance with safety and software standards, the ground truth is established by meeting the specific requirements and clauses of the listed international standards (e.g., IEC 60601-1).

8. Sample Size for Training Set:

Not applicable. This document describes the clearance of an imaging system, not a device incorporating a machine learning algorithm that requires a "training set."

9. How Ground Truth for Training Set Was Established:

Not applicable, as no machine learning training set is described.

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Upon intravenous administration of SPY AGENT™ GREEN (Indocyanine green for injection, USP) the SPY-PHI System is used with SPY AGENT™ GREEN in capturing and viewing fluorescence 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 SPY-PHI System is used with SPY AGENT™ GREEN to provide fluorescence images for the visual assessment of blood flow in vessels and related tissue perfusion before, during and after gastrointestinal surgical procedures.

The SPY-PHI System is an imaging system used in capturing and viewing fluorescent images for the visual assessment of blood flow, as an adjunctive method for the evaluation of tissue perfusion, and related tissuetransfer circulation in tissue and free flaps used during plastic, micro-, reconstructive, and gastrointestinal surgical procedures.

The SPY-PHI System consists of the following main components: Imaging Head/ Imager (HH9030) with an integrated light guide cable and the Video Processor/Illuminator (VPI) (PC9001).

Indocyanine green (ICG) is injected intravenously into the patient. The Imaging Head may be either handheld or attached to a mechanical arm and provides illumination of the regions of a patient's body to be observed with near infrared laser light to excite ICG fluorescence. Alternatively, the Imaging Head provides white light illumination of the reqions of a patient's body to be observed for color imaging.

A CMOS camera in the Imaging Head captures the fluorescent image under laser illumination or a color image under white light illumination. The VPI receives the video signal from the Imaging Head and processes and outputs the video image to a medical grade video monitor and/or video recorder. Adjustments to the operation of the SPY-PHI System are possible through switches at either the Imaging Head or the VPI.

Here's an analysis of the provided text regarding the acceptance criteria and study proving the device meets them, formatted as requested:

Acceptance Criteria and Device Performance Study for SPY Portable Handheld Imaging (SPY-PHI) System (K190729)

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state specific numerical acceptance criteria for clinical performance metrics (e.g., sensitivity, specificity, accuracy) for the SPY-PHI System. Instead, it focuses on demonstrating substantial equivalence to a predicate device by comparing technological characteristics, intended use, and confirming adherence to various safety and performance standards.

Therefore, the "acceptance criteria" primarily relate to compliance with regulatory standards and the "reported device performance" is its demonstrated conformance to these standards and its substantial equivalence to the predicate.

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

The provided text does not include information about a distinct "test set" with a specific sample size, nor does it detail data provenance (e.g., country of origin, retrospective/prospective) for clinical performance evaluation. The submission primarily relies on bench testing, software assessment, and a comparison of technological characteristics to a predicate device to establish substantial equivalence.

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

Given the lack of a distinct clinical "test set" with performance metrics, the document does not mention the number of experts used or their qualifications to establish ground truth. The study is primarily focused on engineering and regulatory compliance rather than clinical accuracy adjudicated by experts.

4. Adjudication Method for the Test Set

As there is no described clinical "test set" with performance data requiring expert review, no adjudication method is mentioned.

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

The provided text does not mention a Multi Reader Multi Case (MRMC) comparative effectiveness study. The submission focuses on demonstrating substantial equivalence through technical and regulatory compliance, not on comparing human reader performance with and without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

The SPY-PHI System is an imaging system designed for visual assessment by a human user ("capturing and viewing fluorescence images for the visual assessment of blood flow"). It is not described as an AI-powered diagnostic algorithm that would operate in a standalone mode without human interpretation. Therefore, a standalone (algorithm-only) study is not applicable or mentioned in this context.

7. The Type of Ground Truth Used

For the safety and performance studies mentioned, the "ground truth" was established by regulatory standards and industry requirements, such as:

• Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60825:2007 for physical device performance.
• Compliance with IEC 62304:2006 for software processes.
• Demonstrating physical compatibility through bench testing for the drug-device combination.
• The overall "ground truth" for the 510(k) submission is the demonstration of substantial equivalence to a previously cleared predicate device.

8. The Sample Size for the Training Set

Since the SPY-PHI System is described as an imaging system and not an AI/machine learning algorithm requiring a "training set" for model development, no training set sample size is mentioned.

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

As no training set is applicable or mentioned, no information on how its ground truth was established is provided.

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Upon intravenous administration of SPY AGENT™ GREEN (Indocyanine green for Injection, USP), the SPY Elite System is used with SPY AGENT™ GREEN to perform intraoperative fluorescence angiography. The SPY Elite System used with SPY AGENT™ GREEN is indicated for use in adult and pediatric patients one month of age and older. The SPY Elite System is indicated for fluorescence imaging of blood flow and tissue perfusion before, during, and after: vascular, gastrointestinal, organ transplant, and plastic, micro- and reconstructive surgeries.

The SPY Elite System is an angiographic fluorescence imaging system which is used for nearinfrared fluorescence imaging during open surgery, with indocyanine green (ICG) as the imaging agent. The SPY Elite System allows surgeons to capture, review, print, and archive high-quality fluorescence images of blood flow in vessels, tissue and organ perfusion in realtime during various surgical procedures.

The SPY Elite System is comprised of an Imaging Console, CINEVAQ software and DICOM Send software. SPY Elite is intended to be used in coniunction with the SPY Elite Pack/Kit which contains ICG, sterile Water for Injection, a sterile equipment drape, instructions for use, and a drug product package insert.

The SPY Elite System, an angiographic fluorescence imaging system, has established its performance through non-clinical testing and clinical literature evaluations.

Here is a summary of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

The "test set" for performance evaluation appears to be composed of aggregated patient data from published clinical literature.

• Sample Size:
  • Macrovascular blood flow: Data from 13 studies.
  • Microvascular blood flow: Data from 33 studies involving 2055 patients.
• Data Provenance: The data is retrospective, derived from systematic summary reviews of existing clinical literature. The country of origin of this literature is not specified, but typically such reviews encompass international publications.

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

The document does not explicitly state the number of experts used to establish ground truth for the test set from the clinical literature reviews, nor their specific qualifications (e.g., "radiologist with 10 years of experience"). However, the assessment of the clinical literature was conducted through "systematic summary reviews," implying a rigorous process, likely involving experts in the relevant surgical fields and medical literature analysis. The ground truth itself is derived from the reported clinical outcomes in these published studies.

4. Adjudication Method for the Test Set

The document describes "systematic summary reviews of the clinical literature" and "meta-analyses reports." This suggests a systematic approach to evaluating and synthesizing findings across multiple studies. While a specific method like "2+1" or "3+1" is not explicitly mentioned for individual case adjudication, the process of systematic review inherently involves methods to assess study quality, consistency, and synthesize results, which acts as a form of adjudication in a meta-analysis context.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study is mentioned comparing human readers with AI assistance versus without AI assistance. The device in question (SPY Elite System) is a fluorescence imaging system that aids surgeons in visualizing blood flow and tissue perfusion; it is not, as described here, an AI-powered diagnostic algorithm intended to work in conjunction with human readers to interpret images. Its function is to provide real-time visual information.

6. Standalone (Algorithm Only) Performance Study

The SPY Elite System is an imaging device that provides visual information in real-time. It is used "in combination with SPY AGENT™ GREEN" (Indocyanine green for Injection, USP). Its performance is inherently linked to this combination and human interpretation of the images. Therefore, a "standalone algorithm only" performance study in the typical sense of an AI model predicting outcomes without human-in-the-loop is not applicable here, as the device's purpose is to enhance human intraoperative visualization. The "visualization rate" mentioned in the performance table reflects the ability of the system to display the required information.

7. Type of Ground Truth Used

The ground truth used for performance evaluation is based on clinical outcomes and observations reported in published medical literature. Specifically, it pertains to the successful visualization of macrovascular blood flow, microvascular blood flow, and tissue perfusion during various surgical procedures, as observed and documented by clinicians in those studies. It also includes the absence of adverse events related to the imaging process.

8. Sample Size for the Training Set

The document primarily focuses on validating the device against existing clinical literature and non-clinical standards. It does not describe a "training set" in the context of an AI/machine learning model developed by the manufacturer. The device is an imaging system, and its development would typically involve engineering and optical design validations, not data-driven model training. The clinical literature reviews served as evidence for its clinical utility and safety, not for training an algorithm.

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

As no "training set" for an AI algorithm is mentioned, this question is not applicable in the context of the provided information. The device is a medical imaging system, not an AI diagnostic tool that requires a training set and corresponding ground truth. Its performance validation relies on demonstrating its ability to accurately capture and display fluorescence signals as confirmed by clinicians in clinical use (as documented in literature) and its adherence to relevant safety and performance standards.

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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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