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The SPY 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 tissue-transfer circulation in tissue and free flaps used in plastic, micro- and reconstructive surgical procedures.

The SPY Imaging System: SP2000 is currently cleared for intraoperative visual assessment of the coronary vasculature and grafts during coronary artery bypass graft (CABG) surgery.

The Novadaq® Technologies SPY® Imaging System consists of 2 components:

• · the SPY Imaging Device; and
• = the SPY Paq™

The SPY Paq is comprised of:

• 6 Novadrape™ custom sterile drapes: and
• = 1 box of IC-Green™ (Indocvanine Green-ICG) imaging agent that contains 6 x 25 mg vials of IC-Green and 6 x 10 ml ampules of sterile Aqueous Solvent.

The IC-Green is supplied intact as received and labeled from the manufacturer of the product.

The SPY Imaging Device consists of an imaging head containing a charge coupled device (CCD) camera, a laser light source, motion sensor and distance sensor attached via an articulating arm to a mobile cart. The mobile cart contains a flat panel display, computer, electronics enclosure and printer.

The SPY System provides the surgeon with the capability to view record and replay fluorescent images of blood flow in vessels and bypass grafts of the heart. A laser light source is used to illuminate the heart surface. IC-Green™ (indocyanine green) is injected intravenously through the central venous line, bypass pump, cardioplegia line and aorto coronary graft and while it is passing through the vessels, the absorption of laser light causes excitation of the dye followed by emission of infrared energy. The result is a fluorescent image of the coronary vasculature. A CCD camera captures the image. These images are used to evaluate the integrity of the coronary vasculature and blood flow in the heart and bypass grafts.

The provided 510(k) summary does not include specific acceptance criteria with numerical thresholds for performance metrics. Instead, it focuses on demonstrating the system's safety and effectiveness through various studies and historical use.

Here's a breakdown of the information requested, based on the provided text:

1. A table of acceptance criteria and the reported device performance

As stated, explicit numerical acceptance criteria are not provided within the document. The "performance" is described qualitatively through the outcomes of the various tests and clinical experiences.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Test Set (Human Clinical Experience for New Indication): The document references images provided in "Section 19 - Clinical" for the new intended use in plastic, micro- and reconstructive surgical procedures. However, it does not explicitly state a specific sample size for a dedicated test set for this new indication. The assessment relies on a qualitative description of the utility of SPY images in these procedures.
• Test Set (CABG Procedures - Previous Indication):
  • Sample Size: 311 patients, with 17 conduits requiring revision.
  • Provenance: This data comes from "The literature reports," indicating it's likely from published studies. The document mentions the SPY System is commercially available in the United States, Japan, Europe, and Canada, so the provenance of these specific 311 patients is not pinpointed to a single country. There is no explicit mention of retrospective or prospective for this specific set of 311 patients.
• Test Set (Animal Studies - Original 510(k)):
  • Sample Size: Six pig studies.
  • Provenance: Not explicitly stated, but likely laboratory-based (prospective within a controlled environment).

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)

• The document describes clinical utility in Cabg (where surgeons use the system to identify issues) and in plastic, micro-, and reconstructive surgery (where images aid medical staff in assessing flap viability, along with other standard practices).
• For the CABG procedures, the determination of graft patency issues and the need for revision would have been made by surgeons. The document states, "allowing the surgeon to revise the graft." No specific number or qualification level (e.g., "radiologist with 10 years of experience") for these surgeons is provided beyond their role as "surgeon."
• For the new indication, "medical staff" are mentioned as being aided in assessing flap viability. Again, no specific number or detailed qualifications are provided.
• The "ground truth" in these clinical settings appears to be the intraoperative findings and the clinical judgment of the treating physicians.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The document does not describe any formal adjudication method (like 2+1 or 3+1 consensus) for the "test sets" or clinical findings. Clinical decisions were made by the operating surgeons or medical staff.

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

• No MRMC study was performed or described.
• This device is an imaging system, not an AI-driven diagnostic tool that assists human readers in interpreting images in the typical MRMC study context. It provides a visual assessment of blood flow intra-operatively or post-surgery.
• Therefore, there's no mention of an effect size comparing human readers with AI assistance versus without.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• This device is not an algorithm-only device. It is an imaging system designed to be used with human operators (surgeons, medical staff) for visual assessment. The "algorithm" here is the system's ability to capture and display fluorescent images. The "ground truth" derived from its use is interpreted by humans in a clinical context.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Clinical Ground Truth / Intraoperative Findings: For CABG, the ground truth was the intraoperative assessment of graft patency by surgeons, leading to revision where necessary. The positive outcome (decreased myocardial infarctions, morbidity, and mortality) serves as indirect outcomes data.
• Clinical Judgment / Visual Assessment: For the new indication, the ground truth for flap viability assessment is based on the visual assessment of blood flow by medical staff, combined with "other standard practices, such as evaluation of flap color, temperature, time for recapillarization and bleeding after puncture."
• Physiological Response / Direct Observation: For animal studies, the ground truth was direct physiological observation (e.g., no detrimental effects on heart function, no increase in myocardial tissue temperature, ability to visualize coronary beds).

8. The sample size for the training set

• The document does not describe the SPY Imaging System as an AI/machine learning device that requires a "training set" in the conventional sense. Therefore, there is no mention of a training set sample size.
• The device's functionality is based on established physical principles of fluorescence imaging rather than machine learning algorithms.

9. How the ground truth for the training set was established

• As there is no training set for an AI/ML algorithm, this question is not applicable.

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