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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 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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