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Upon intravenous administration of SPY AGENT GREEN (indocyanine green for injection, USP), the SPY-PH 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, 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.

Upon intradermal administration of SPY AGENT GREEN, the SPY-PHI System is indicated for fluorescence imaging of lymph nodes and delineation of lymphatic vessels during lymphatic mapping in adults with breast cancer for which this procedure is a component of intraoperative management.

The SPY-PHI System is a real-time white-light and near-infrared illumination/ fluorescence imaging system used during open-field surgical procedures. Near-infrared illumination is used for fluorescence imaging using SPY AGENT® GREEN for the visual assessment of blood flow, tissue perfusion and visualization of the lymphatic system, including lymphatic vessels and lymph nodes. It consists of the SPY Portable Handheld Imager/ imaging head with an integrated light guide and camera cable and the Video Processor/ Illuminator. Additionally, SPY-QP Fluorescence Assessment Software is provided as an optional upgrade to the SPY-PHI System that enables relative quantification of NIR fluorescence.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: 152 subjects enrolled in the FILM-B study.
• Data Provenance: The FILM-B study was a prospective and multi-center clinical study. The document does not explicitly state the country of origin, but it was conducted under an IDE (G170109) in accordance with 21 CFR 812, implying it was conducted under U.S. FDA regulations.

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

The text states that "The resected tissues were evaluated by histopathology to confirm presence of lymph nodes." It does not specify the number of histopathology experts or their qualifications. However, histopathology is a well-established method for confirming the presence of lymph nodes and is typically performed by trained pathologists.

4. Adjudication Method for the Test Set

The document does not explicitly mention an adjudication method (e.g., 2+1, 3+1) for establishing the ground truth. It states that histopathology was used to confirm the presence of lymph nodes, which is a definitive diagnostic method. For the comparison of identification rates (SPY-PHI vs. Tc99m/gamma probe), the comparison involved the outcomes of two different intraoperative real-time methods against this histopathology-confirmed ground truth.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, 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 explicitly done in the context of human readers improving with AI assistance.
• The study compared the device (SPY-PHI system used by surgeons intraoperatively) to another clinical method (Tc99m/gamma probe used by surgeons). It evaluates the device itself in a real-world surgical setting, not directly how human readers (like radiologists or pathologists) improve their diagnostic performance with AI assistance.
• The comparison focused on the utility of the SPY-PHI system with SPY AGENT GREEN for surgeons during lymphatic mapping for breast cancer, specifically in identifying lymph nodes and visualizing lymphatic vessels, compared to the traditional Tc99m/gamma probe.
• The "effect size" mentioned (a 23% difference in identified lymph nodes between SPY-PHI and Tc99m/gamma probe) refers to the comparative effectiveness of the device-dye system versus the traditional method, not an AI assistance effect on human reader interpretation.

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

No, a standalone (algorithm only) performance study was not done in the context of this submission. The SPY-PHI System is described as a fluorescence imaging system used during open-field surgical procedures with intraoperative fluorescence angiography. The clinical study (FILM-B) evaluates its use by surgeons during procedures.

7. The Type of Ground Truth Used

The primary ground truth used for confirming the presence of lymph nodes was histopathology. This is considered a definitive diagnostic standard.

8. The Sample Size for the Training Set

The document does not mention a separate "training set" or its sample size. The clinical study (FILM-B) of 152 subjects appears to be the primary dataset for assessing the stated clinical effectiveness of the device. This device is an imaging system, not a machine learning algorithm that typically requires a large training set for development. The "Software" section mentions compliance with IEC 62304 standards, which applies to medical device software life cycle processes, but doesn't imply a machine learning development paradigm with distinct training/testing sets in the conventional AI sense.

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

As no specific training set for a machine learning model is mentioned, the method for establishing its ground truth is not applicable or detailed in the provided text.

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