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The SPY Fluorescent Imaging 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 in plastic, micro- and reconstructive surgical procedures.

The SPY Fluorescent Imaging System used in plastic, micro, and reconstructive surgery indication consists of 2 components: the SP2001 Imaging Device and the SPY Paq. The SP2001 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, a computer with keyboard and optical mouse, an electronics enclosure, and a printer. The SPY System provides the surgeon with the capability to view, record, and replay fluorescent images of blood flow in vessels and organs. A laser light source is used to illuminate the area of interest. In order to obtain the images, ICG is injected intravenously through the central or peripheral venous line. While the ICG is passing through the vessels, the absorption of laser light causes excitation of the ICG dye, followed by the emission of infrared energy. A CCD camera of the SP2000 Imaging Device captures the infrared emission, resulting in a fluorescent image of blood flow and related tissue perfusion. These images are used to evaluate the integrity of native and grafted vasculature and blood flow in the organs. The SP2001 Imaging Device represents minor modifications of the SP2000 Imaging Device: The maximum recording time for image sequences captured has been extended to 60 seconds from the 34 seconds of the SP2000 Imaging Device. An ability to move the SP2001 camera head in horizontal plane during image sequence acquisition has been implemented. A variable Laser Power Attenuator has been added to the device to permit laser illumination at power levels lower or equal to the laser power level of the SP2000 Imaging Device. New HELIOS software has been developed to support the SPY System in its plastic, micro-, and reconstructive surgery indication.

Here's a breakdown of the acceptance criteria and study information for the SPY® Fluorescent Imaging System (SP2001 Imaging Device) based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

It's important to note that this 510(k) submission (K073088) is for a device modification (SP2001) of an already cleared device (SP2000). The primary focus of the testing described is to demonstrate that the modifications do not introduce any new safety concerns and that the modified device remains substantially equivalent to its predicate device, while enhancing functionality for plastic, micro-, and reconstructive surgery. Therefore, the "acceptance criteria" are generally related to safety and the ability to produce high-quality images as demonstrated by previous studies and the current assessment of the modifications.

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

Since this filing is primarily about a modification to an already cleared device and relies heavily on previously submitted data and widespread clinical use, there isn't a single "test set" in the traditional sense for this specific 510(k). The data provenance is a combination:

• Human Clinical Experience:
  • Sample Size: Over 7000 vascular procedures (cumulative across all indications for prior clearances).
  • Data Provenance: Commercially available in the United States, Japan, Europe, and Canada. This indicates both prospective and retrospective data collection over time in a real-world clinical setting.
  • Specific Example from Literature Review: 311 patients where 17 conduits required revision. This is from published peer-reviewed articles.
• Animal Studies (for original 510(k) and foundational safety):
  • Sample Size: Six pig studies.
  • Data Provenance: Not specified, but likely conducted by the manufacturer or research partners. These were "to support the original traditional 510(k) premarket notification" (K042961).
• In Vitro Testing: Not applicable to "test set" in this context, but refers to laboratory testing for standards compliance (electrical, EMC, laser).

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

The concept of a formalized "ground truth" derived from a specific number of experts for a single test set, as might be common in AI/algorithm validation, is not explicitly detailed in this 510(k) for the SP2001 device modification.

• Human Clinical Experience: The "ground truth" arises from the clinical outcomes and the surgical decisions made by operating surgeons based on the visual assessment provided by the SPY System. For instance, in the 311 patients where 17 conduits required revision, the surgeon's decision to revise implicitly serves as an "expert ground truth" that the device correctly informed. The "experts" are the surgeons using the device. Their qualifications are not specified beyond being "surgeons" performing vascular, plastic, micro-, and reconstructive procedures.
• Animal Studies: The "ground truth" would have been established by direct observation and physiological measurements in the pig studies (e.g., no detrimental effects on heart function, coronary flow, myocardial tissue temperature). The experts would be the researchers and veterinarians conducting those studies.

4. Adjudication Method for the Test Set

Again, given the nature of a device modification relying on existing clinical experience, a formal adjudication method (like 2+1 or 3+1 used in AI studies) for a dedicated "test set" is not described.

• Clinical Use: Clinical decisions in surgery are inherently "adjudicated" by the practicing surgeon's judgment and experience, often incorporating other diagnostic information, physical examination, and surgical observation, not solely the device output. The device is described as an "adjunctive method."
• Literature Reports: The reported clinical utility from peer-reviewed articles would reflect consensus findings within the broader medical community, implying a form of expert review and publication acceptance.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study that specifically measures the effect size of human readers improving with this device (SP2001) vs. without AI assistance is not explicitly mentioned or described in this 510(k) summary.

The SPY System is an imaging device that provides visual information to the surgeon, not an AI-driven diagnostic algorithm that provides interpretation or assistance in the way modern AI tools do. Its improvements are primarily in extending the visual capabilities (longer recording, wider field of view) for the human user.

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

No, a standalone performance study in the context of an algorithm or AI is not applicable or described. The SPY® Fluorescent Imaging System is an imaging tool designed for human-in-the-loop visual assessment. It captures images; it does not interpret them standalone.

7. The Type of Ground Truth Used

The ground truth used is predominantly a combination of:

• Clinical Outcomes/Surgical Decision-Making: For humans, the ultimate "ground truth" for assessing tissue perfusion and blood flow is whether the surgical procedure is successful, whether revisions are needed, and the subsequent patient outcomes. Decisions made by surgeons based on the images are a direct form of clinical ground truth about the physiological state.
• Physiological Measurements/Direct Observation (Animal Studies): In the pig studies, the ground truth was established by direct physiological measurements and observations of heart function, coronary flow, myocardial temperature, etc.
• Pathology/Histology/Outcomes Data: While not explicitly stated for every case, the implications of successful graft revisions (reducing myocardial infarctions, morbidity, mortality) suggest that long-term outcomes and potentially pathological findings (e.g., if a graft failed) would serve as ultimate ground truth checks.

8. The Sample Size for the Training Set

No training set is mentioned as this device is not an AI/ML algorithm requiring a training set. It is a hardware and software system for image acquisition and display.

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

Not applicable, as there is no training set for an AI/ML algorithm.

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The SPY® Fluorescent Imaging System is intended to intra-operatively enable surgeons to visually assess blood flow and related tissue perfusion during organ transplant procedures.

The Novadag® Technologies SPY® Fluorescent Imaging System used in plastic, micro, and reconstructive surgery indication consists of 2 components:

• · the SP2001 Imaging Device
• · the SPY Paq®

The SPY Pags are available in 2 configurations dependent on the intended indication for use. Each SPY Paq contains sufficient number of ICG, custom sterile drapes called Novadrape®, and diluent for 6 imaging procedures. Each configuration of SPY Pag has a unique part number assigned to it, and different Instructions for Use exist for the two types of SPY Pags. The different Instructions for Use also have unique part numbers for ease of assembly of the Pags and quidance for the end user.

The SP2000 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, a computer with keyboard and optical mouse, an electronics enclosure, and a printer.

The SPY® System provides the surgeon with the capability to view, record, and replay fluorescent images of blood flow in vessels and organs. A laser light source is used to illuminate the area of interest. In order to obtain the images, ICG is injected intravenously through the central or peripheral venous line, bypass pump, cardioplegia line, or down a coronary graft. While the ICG is passing through the vessels, the absorption of laser light causes excitation of the ICG dye, followed by the emission of infrared energy. A CCD camera of the SP2000 Imaging Device captures the infrared emission, resulting in a fluorescent image of blood flow and related tissue perfusion. These images are used to evaluate the integrity of native and grafted vasculature and blood flow in the organs.

The SP2001 Imaging Device represents a modification of the SP2000 Imaging Device in the following ways:

• The maximum recording time for image sequences captured has been extended to 60 seconds from the 34 seconds of the SP2000 Imaging Device.
• An ability to move the SP2001 camera head in horizontal plane during image sequence acquisition has been implemented.
• A variable Laser Power Attenuator has been added to the device to permit laser illumination at power levels lower or equal to the laser power level of the SP2000 Imaging Device.
• New HELIOS 10 software has been developed to support the SPY System in its organ transplant surgery indication.

Here's an analysis of the provided 510(k) summary regarding the SPY® Fluorescent Imaging System (SP2001) for use in organ transplant procedures, focusing on acceptance criteria and supporting studies.

It's important to note that a 510(k) summary is a high-level overview. Detailed acceptance criteria and study designs are typically found in the full 510(k) submission, which is not provided here. Therefore, some information may be inferred or stated as "not specified" based on the available text.

Acceptance Criteria and Device Performance

The provided document primarily focuses on demonstrating substantial equivalence to predicate devices and expanding the Indications for Use, rather than explicitly stating quantitative performance acceptance criteria in the context of a new efficacy study. The "acceptance criteria" here are largely met by demonstrating safety, effectiveness, and equivalence to existing cleared devices, particularly for the expanded indication.

Based on the document, the de-facto acceptance criteria for this 510(k) submission revolve around:

1. Safety: No adverse acute or long-term cellular, renal, or hepatic effects from device use, and exposure levels below maximum permissible limits.
2. Effectiveness/Utility: Ability to acquire high-quality, reproducible fluorescent images of blood flow and tissue perfusion, enabling surgeons to visually assess these parameters.
3. Equivalence: The modified SP2001 device for organ transplant procedures is as safe and effective as the predicate SP2000 device and other legally marketed devices, with enhanced functionality.

Study Proving Device Meets Acceptance Criteria:

The current 510(k) relies on a combination of previous clearances, existing clinical experience, and minimal new data specifically for the organ transplant indication.

1. Sample size used for the test set and data provenance:

   • Test Set for Organ Transplant Indication: "31 cases in the United States and 18 reported in the literature from Japan" (total 49 cases) of human clinical experience. This data is retrospective from real-world use.
   • Previous Indications (CABG, etc.): "over 7000 vascular procedures in humans" (global, retrospective/real-world), and "six pig studies" (prospective, animal). Data provenance for the 7000 human procedures is unspecified beyond being "in the United States of America, Japan, Europe, and Canada."

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not explicitly specified for the 49 organ transplant cases. The assessment of blood flow and tissue perfusion appears to be a direct visual assessment by the attending surgeons during the procedures. The document refers to "surgeons" being able to assess blood flow, implying their intra-operative judgment serves as a form of ground truth.
   • For the CABG data, the ground truth of "lack of patency" was identified by the surgeon, leading to revision.

3. Adjudication method for the test set:

   • Not specified. Given the nature of intra-operative visual assessment by the operating surgeon, it's unlikely a formal adjudication process involving multiple independent experts was performed for each case in the real-world usage described. The surgeon's decision to revise a graft, for instance, implies their assessment/ground truth.

4. 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, an MRMC comparative effectiveness study was not done. The SPY System is an imaging device, and this submission is for an expanded indication for use, not for an AI/CAD product or an assessment of human reader performance improvement with AI assistance.

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

   • Not applicable. The SPY System is a device that provides visual information to the surgeon for assessment; it is not a standalone algorithm making diagnostic or decision-making outputs. The human (surgeon) is inherently "in-the-loop."

6. The type of ground truth used:

   • Surgeon's Intra-operative Visual Assessment/Clinical Judgment/Outcomes Data (for revisions): For the human cases, the ground truth is derived from the surgeon's observation and their subsequent actions (e.g., revising a graft). For the organ transplant cases, the ground truth is stated as the system enabling "surgeons to visually assess blood flow." In the CABG context, instances requiring "revision" clearly indicate identifying a clinical issue, which serves as a form of outcome-based ground truth related to the system's utility.
   • Physiological measurements in animal studies: For the pig studies, ground truth included the ability to acquire high-quality images, lack of detrimental effects on heart function/coronary flow, and no increase in myocardial tissue temperature.

7. The sample size for the training set:

   • Not applicable in the traditional sense. The 510(k) process for this device relies on prior clearances, general clinical experience (over 7000 procedures), and a smaller set of clinical experience for the new indication (49 organ transplant cases) for validation, not for training a new algorithm. The "HELIOS 10 software" mentioned as new was based on a "cleared DaqPac software" and focused on interface and reporting, not on a machine learning model that would require a dedicated training set.

8. How the ground truth for the training set was established:

   • Not applicable. As there isn't a "training set" in the context of a machine learning algorithm, the concept of establishing ground truth for it does not apply to this submission. The development of the device and its various software iterations would have relied on engineering verification and validation, as well as clinical feedback, but not a formally labeled "training set" for a learning algorithm.

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The SPY Fluorescent Imaging System is intended to provide fluorescent images for the visual assessment of blood flow in vessels and related tissue perfusion during cardiovascular surgical procedures.

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

• the SP2000 Imaging Device; and
• the SPY Paq®

The SPY Pag constitutes a 6 procedure kit. Each SPY Pag contains The Sir I aq constitution a o procours ... " procedures ... " leG and diluent to carry out 6 cardiovascular imaging procedures. Novadaq provides the ICG as it is sold by the manufacturer and does not adulterate the integrity of the original packaging or labeling. IC-Green™ (Akorn, Inc.) is packaged in an IC-Green kit that contains 6 x 25 mg vials of ICG along with 6 x 10 ml ampules of Aqueous Solvent.

The SP2000 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 area of interest. ICG is injected intravenously through the central venous line, bypass pump, cardioplegia line and 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 blood flow and related tissue perfusion in the vessels. 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 text describes the Novadaq SPY Fluorescent Imaging System (SPY System), model SP2000, and its expanded indications for use. It outlines testing conducted to support the device's safety and effectiveness.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the traditional sense of specific, quantifiable metrics that the device must achieve (e.g., sensitivity, specificity, accuracy against a gold standard). Instead, it describes general safety and performance assessments. The reported device performance is qualitative and based on the ability to produce high-quality images and a lack of adverse effects.

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

• Human Data:
  • Sample Size: Over 4000 CABG procedures (for general market availability and safety data) and 311 patients (for specific outcome data mentioned in peer-reviewed literature for identifying conduits requiring revision).
  • Data Provenance: "Commercially available in the United States of America, Japan, Europe and Canada." This suggests retrospective (post-market surveillance) data collected from various countries.
• Animal Data:
  • Sample Size: Six pig studies.
  • Data Provenance: Not explicitly stated, but likely conducted in a controlled lab or animal facility. This would be prospective data for the original 510(k).

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

The document does not specify the number of experts or their qualifications for establishing ground truth for the human or animal test sets.

For the human data, the "literature reports" refer to surgeons (implied experts) identifying an issue and performing revisions, suggesting the clinical judgment of the operating surgeon as a form of ground truth for that specific outcome.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method. For the human data, the "literature reports that the SPY System was able to... identify 17 conduits... that required revision," implying that the need for revision was determined by the operating surgeon(s) based on intraoperative findings and the SPY system's input, but no formal adjudication process is detailed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a MRMC comparative effectiveness study was not explicitly mentioned or described. The document focuses on the standalone performance and safety of the device, and qualitative improvements due to intraoperative visualization. It doesn't report on an effect size of human readers improving with AI vs. without AI assistance, as this is not an AI-assisted device in the sense of predictive or diagnostic algorithms.

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

The SPY System is an imaging device meant for human-in-the-loop performance. It provides visual information to the surgeon. Therefore, a purely "standalone" (algorithm-only) performance evaluation, separate from human interpretation, is not applicable or described for this type of device. The system's "performance" is its ability to acquire high-quality images of blood flow for human assessment.

7. The Type of Ground Truth Used

• Human Data:
  • For safety: Absence of reported adverse acute or long-term cellular, renal, or hepatic effects; absence of reported major complications in over 4000 CABG procedures.
  • For effectiveness: Surgeon judgment/intraoperative findings (the need for graft revision identified by the SPY system and confirmed by the surgeon), and the ability to visualize various vascular beds and perfusion.
• Animal Data:
  • Direct physiological measurements (e.g., heart function, coronary flow, peripheral pressure, myocardial tissue temperature, electrocardiograms, arterial pressures, cellular, renal, hepatic effects).
  • Visual assessment by researchers/veterinarians of image quality and visualization capabilities.

8. The Sample Size for the Training Set

This report does not mention a training set in the context of an AI/machine learning algorithm. The SPY System is an imaging device, not a diagnostic algorithm that requires a "training set" in the typical sense. Its development would involve engineering and optical design validations, not data-driven model training.

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

As there is no mention of a training set for an AI/machine learning algorithm, this question is not applicable based on the provided text.

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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 tissuetransfer circulation in tissue and free flaps used in plastic, micro- and reconstructive surgical procedures.

The Novadaq® Technologies SPY® Fluorescent Imaging System consists of 2 components: the SP2000 Imaging Device and the SPY Paq®. The SP2000 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 area of interest. ICG is injected intravenously through the central or peripheral venous line, bypass pump, cardioplegia line and 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 blood flow and related tissue perfusion in the vessels. A CCD camera captures the image.

The provided document, K072222, is a 510(k) summary for the SPY® Fluorescent Imaging System (SP2000 model), specifically concerning a proposed change to allow the use of an alternative brand of Indocyanine Green (ICG) dye (ICG Pulsation®) in addition to the already approved IC-Green™.

The document does not describe a study that explicitly sets acceptance criteria for device performance and then proves the device meets those criteria with specific statistical metrics. Instead, it focuses on demonstrating substantial equivalence to previously cleared predicate devices and proving the safety and effectiveness of using the new brand of ICG with the existing system. The "acceptance criteria" can therefore be inferred from the rigorous testing and positive clinical outcomes reported in previously cleared indications and the current submission's focus on equivalence.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Since explicit acceptance criteria with numerical targets are not stated, the table below infers the performance goals based on the described safety and effectiveness outcomes. The "Reported Device Performance" reflects the evidence presented to demonstrate that these inferred criteria are met.

2. Sample Sizes and Data Provenance

• Test Set Sample Size:
  • Human Data: Over 4000 CABG procedures.
  • Animal Data: Six (6) pig studies.
• Data Provenance:
  • Human Data: Retrospective and prospective (implied by "commercially available," "over 4000 CABG procedures," and "literature reports"). Originated in Europe, Japan, and Canada.
  • Animal Data: Prospective (specifically conducted for original 510(k)).

3. Number of Experts and Qualifications for Ground Truth

The document does not explicitly state the number of experts used to establish ground truth for this specific 510(k) submission's equivalence testing of the ICG brands.

However, for the original studies and clinical utility, it refers to:

• "surgeons" using the system.
• "literature reports" from 12 peer-reviewed journal articles, implying assessment and validation by medical professionals (surgeons, clinicians, researchers).

The qualifications of these experts are not explicitly detailed but would implicitly be surgeons and other medical specialists involved in cardiovascular, plastic, micro- and reconstructive surgeries, and researchers in those fields who authored or reviewed the peer-reviewed articles.

4. Adjudication Method

The document does not describe a formal adjudication method (like 2+1 or 3+1 consensus) for the test set as would typically be done for a diagnostic AI device. The evaluation of patency and the decision for revision were clinical decisions made by the operating surgeons based on the real-time SPY system images. The "ground truth" here is the clinical outcome or intervention guided by the system's visualization.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study is mentioned comparing human readers with and without AI assistance. The SPY system is an imaging device, not an AI algorithm in the contemporary sense. It provides intra-operative visual assessment of blood flow to assist the surgeon, implying human-in-the-loop use. The document describes clinical utility and safety, not an improvement in human reader performance with AI versus without AI assistance.

6. Standalone (Algorithm Only) Performance

Not applicable. The SPY system is a medical imaging device used intra-operatively by surgeons to visualize blood flow. It is intrinsically a human-in-the-loop system and not a standalone algorithm.

7. Type of Ground Truth Used

The ground truth used is primarily clinical observation/outcomes and expert judgment (surgical decisions).

• For the original CABG use, the "lack of patency was visualized clearly by the SPY System... allowing the surgeon to revise the graft." The successful revision and subsequent decrease in myocardial infarctions and morbidity/mortality serve as ultimate clinical ground truth for the system's utility.
• For safety, lack of adverse events (cellular, renal, hepatic, cardiac function) observed during real-world use and animal studies serves as ground truth.
• For image quality, expert assessment by surgeons and researchers (implied by peer-reviewed publications) provides the ground truth.
• In pig studies, direct physiological measurements (heart function, coronary flow, peripheral pressure, myocardial tissue temperature) were used.

8. Sample Size for Training Set

The concept of a "training set" is not applicable as this is not an AI/machine learning device. The previous human experience and animal studies (from prior 510(k)s) could be considered analogous to a "development dataset" or "validation dataset" in that they established the device's fundamental capabilities.

9. How Ground Truth for Training Set Was Established

Not applicable as there is no training set in the AI sense. For the underlying science and validation of the device:

• Original 510(k) (K042961) and subsequent clearances:
  • Animal studies: Physiological measurements, direct observation, and imaging outcomes in six pigs.
  • Human experience: Intra-operative visual assessment by surgeons, clinical outcomes, and lack of reported adverse events over 4000 CABG procedures.
  • In vitro testing: Conformance to electrical, electromagnetic, and laser safety standards (IEC, UL, CFR, ANSI).
    The combination of these methods established the ground truth for the device's initial safety and effectiveness. The current submission leverages this existing ground truth to demonstrate equivalence for the new ICG brand.

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