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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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