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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

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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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