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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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