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The SPY Phi Open Field Handheld Fluorescence Imaging System is an imaging system used 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 Open Field Handheld Fluorescence Imaging System is intended to provide fluorescence images for the visual assessment of blood flow in vessels and related tissue perfusion during gastrointestinal surgical procedures.

The SPY PHI HH9000 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 in tissue and free flaps used during plastic, micro-, reconstructive, and gastrointestinal surgeries.

The SPY PHI HH9000 consists of the following components: an Open Field Handheld Imaging Head (HH9030), Light Guide (PC9004), 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 SPY PHI are possible through switches at either the Imaging Head or the VPI.

The provided text describes the SPY Phi Open Field Handheld Fluorescence Imaging System (SPY PHI HH9000). However, it does not contain explicit details about acceptance criteria, a specific study proving device performance against those criteria, or the typical elements of a clinical effectiveness study (like sample sizes for test/training sets, expert qualifications, adjudication methods, or MRMC studies).

Instead, the document focuses on:

• 510(k) summary: Demonstrating substantial equivalence to predicate devices for FDA clearance.
• Device description and indications for use: Explaining what the device is and how it's intended to be used.
• Non-clinical performance testing: Compliance with various IEC standards for electrical safety, laser safety, and software lifecycle.
• Animal testing: Assessing design suitability and in vivo fluorescence imaging capability in a porcine model.

Therefore, many of your requested points cannot be directly answered from the provided text.

Here's an attempt to answer what can be extracted and to highlight what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table of acceptance criteria or quantitative reported device performance in terms of clinical metrics (e.g., sensitivity, specificity, accuracy) for human tissue. The "Performance Data" section discusses compliance with safety and electrical standards and animal studies to support intended use.

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

• Test Set Sample Size: Not specified for human data. The document mentions "Animal Testing - Validation Data" which used a "porcine model."
• Data Provenance: The animal study was conducted using a porcine model. No human clinical data provenance (country, retrospective/prospective) is provided in this document.

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

This information is not provided for any human clinical test set, as such a study is not detailed. For the animal study, the document doesn't specify if experts were used to establish ground truth or their qualifications.

4. Adjudication Method for the Test Set

This information is not provided as a human clinical effectiveness study is not detailed.

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

No, the document does not indicate that an MRMC comparative effectiveness study was done, nor does it report any effect size for human readers improving with or without AI assistance. The device described appears to be an imaging system, not an AI-powered diagnostic tool in the sense of providing automated interpretations.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

This information is not applicable/provided. The SPY PHI is an imaging system for "visual assessment of blood flow," implying human interpretation of the images. It's not described as an algorithm for automated diagnosis or a standalone AI product.

7. The Type of Ground Truth Used

• For the non-clinical testing, the "ground truth" was compliance with established IEC standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60825, IEC 62304).
• For the animal study, the ground truth was the "suitability of the design requirements... to meet user needs and evaluated the in vivo fluorescence imaging capability... in the visualization of blood flow and tissue perfusion." This suggests a qualitative assessment of whether the system could visualize what it was intended to based on physiological changes or known anatomy in the porcine model. No specific "pathology" or "outcomes data" ground truth is mentioned in relation to a human test set.

8. The Sample Size for the Training Set

This information is not applicable/provided. The SPY PHI is an imaging system hardware (with associated software), not an AI algorithm that undergoes "training" in the traditional sense on a large dataset for image interpretation. The software assessment mentioned (IEC 62304) is about software lifecycle processes, not machine learning model training.

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

This information is not applicable/provided for the reasons stated in point 8.

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The PINPOINT Endoscopic Fluorescence Imaging System is indicated for use to provide real time endoscopic visible and near-infrared fluorescence imaging.

The PINPOINT System enables surgeons to perform minimally invasive surgery using standard endoscope visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct or common hepatic duct), using near-infrared imaging.

Fluorescence imaging of biliary ducts with the PINPOINT System is intended for use with standard of care white light, and when indicated, intraoperative cholangiography. The device is not intended for standalone use for biliary duct visualization.

The PINPOINT Endoscopic Fluorescence Imaging System (PINPOINT, PINPOINT System) is comprised of an endoscopic video processor/ illuminator (VPI) which is capable of providing visible and near-infrared illumination to a surgical laparoscope, surgical laparoscopes optimized for visible (VIS) and near-infrared (NIR) illumination and imaging, a camera head that is also optimized for visible and near-infrared imaging, and a flexible light quide cable. The following laparoscope models are included as part of the PINPOINT System: SC9100, SC9104, SC9130, SC9131, SC9134, SC9144, SC9504, SC9534 and SC9544. These are the major components of the PINPOINT System.

During surgical procedures, PINPOINT may be operated to provide visualization similar to that provided by conventional imaging systems used in surgical endoscopy. The area of interest is illuminated with visible light from the illuminator and the resulting reflected light is imaged by the camera and displayed on the video monitor. When used with the VIS-only laparoscopes, the System is only capable of the conventional mode of visualization described herein.

To provide NIR fluorescence imaging, PINPOINT is used with the imaging agent, indocvanine green (ICG). The patient is injected with ICG imaging agent. The ICG fluoresces when illuminated through the laparoscope with NIR excitation light from the VPI, and the fluorescence response is then imaged with the camera, processed and displayed on an HD video monitor.

When used with a VIS/NIR laparoscope, PINPOINT can operate to provide illumination and imaging of both visible light and ICG fluorescence images simultaneously.

The provided text does not contain detailed information about specific acceptance criteria or a dedicated study proving the device meets these criteria in the format requested. The document is a 510(k) summary for the PINPOINT Endoscopic Fluorescence Imaging System, which primarily focuses on demonstrating substantial equivalence to a predicate device.

However, based on the non-clinical performance testing section, we can infer some general acceptance criteria related to safety and performance through adherence to standards.

Here's an attempt to extract and present the information, acknowledging the limitations of the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the study proving the device meets acceptance criteria:

The document describes "Non-Clinical Performance Testing" which includes adherence to various IEC standards and animal testing. This is the "study" demonstrating performance against safety and basic functional criteria. However, it's not a typical clinical study with patient outcomes or a reader study.

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

• Test Set Sample Size:
  • For the in vivo fluorescence imaging capability, the "test set" was a porcine model. The exact number of animals is not specified.
  • For the other performance tests (IEC standards), these are typically performed on hardware and software and do not involve a "test set" in the sense of patient data.
• Data Provenance:
  • The animal testing (porcine model) appears to be prospective and conducted by NOVADAQ.
  • The standards conformance testing was conducted by NOVADAQ and accredited third-party laboratories.

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

• This information is not provided in the document. The animal model study used to validate in vivo fluorescence imaging would likely have involved veterinarians or surgical experts, but their number and qualifications are not detailed. For the standards testing, "ground truth" is typically defined by the standard itself rather than expert consensus on a test set.

4. Adjudication Method for the Test Set

• This information is not provided. Given the nature of the tests described (animal model and standards conformance), a formal adjudication method like 2+1 or 3+1 is unlikely to have been used, as these are typically reserved for image interpretation studies.

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 comparative effectiveness study is mentioned. This device is an imaging system, not an AI-powered diagnostic tool, so such a study would not be directly applicable in the sense of "human readers improve with AI." The document focuses on the system's ability to provide visual assessment of vessels, blood flow, and bile ducts using near-infrared imaging alongside visible light.

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

• This device is an imaging system used in real-time by surgeons; it is not an algorithm that performs a standalone diagnostic function. Therefore, a standalone algorithm performance study is not applicable and not mentioned. The device's "performance" is its ability to acquire and display images.

7. The type of ground truth used

• For the in vivo fluorescence imaging validation, the ground truth was likely physiological observation within the porcine model by trained personnel, confirming the system's ability to visualize expected fluorescence in living tissue after ICG administration.
• For the standards conformance tests, the "ground truth" is the requirements outlined in the respective IEC and UL standards.

8. The sample size for the training set

• This device is an imaging system, not a machine learning algorithm that requires a "training set" in the conventional sense. Therefore, information about a training set sample size is not applicable and not provided.

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

• As there is no mention of a training set, this information is not applicable.

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The PINPOINT Endoscopic Fluorescence Imaging System is indicated for use to provide real time endoscopic visible and near-infrared fluorescence imaging.

The PINPOINT System enables surgeons to perform minimally invasive surgery using standard endoscope visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct or common hepatic duct), using near-infrared imaging.

Fluorescence imaging of biliary ducts with the PINPOINT System is intended for use with standard of care white light, and when indicated, intraoperative cholangiography. The device is not intended for standalone use for biliary duct visualization.

The PINPOINT Endoscopic Fluorescence Imaging System (PINPOINT, PINPOINT System) is comprised of an endoscopic video processor/ illuminator (VPI) which is capable of providing visible and near-infrared illumination to a surgical laparoscope, surgical laparoscopes optimized for visible (VIS) and near-infrared (NIR) illumination and imaging, a camera head that is also optimized for visible and near-infrared imaging, and a flexible light guide cable. The following laparoscope models are included as part of the PINPOINT System: SC9100, SC9104, SC9130, SC9131, SC9134 and SC9144. These are the major components of the PINPOINT System.

During surgical procedures, PINPOINT may be operated to provide visualization similar to that provided by conventional imaging systems used in surgical endoscopy. The area of interest is illuminated with visible light from the illuminator and the resulting reflected light is imaged by the camera and displayed on the video monitor. When used with the VIS-only laparoscopes, the System is only capable of the conventional mode of visualization described herein.

To provide NIR fluorescence imaging, PINPOINT is used with the imaging agent, indocyanine green (ICG). The patient is injected with ICG imaging agent. The ICG fluoresces when illuminated through the laparoscope with NIR excitation light from the VPI, and the fluorescence response is then imaged with the camera, processed and displayed on an HD video monitor.

When used with a VIS/NIR laparoscope, PINPOINT can operate to provide illumination and imaging of both visible light and ICG fluorescence images simultaneously.

The provided text includes a 510(k) summary for the PINPOINT Endoscopic Fluorescence Imaging System, which describes performance data. However, it does not include specific acceptance criteria or a detailed study proving the device meets those criteria in the format requested.

Here's what can be extracted and what information is missing based on your request:

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

• Acceptance Criteria: Not explicitly stated in the document. The document primarily focuses on demonstrating substantial equivalence to predicate devices and conformance to general safety and performance standards.
• Reported Device Performance:
  • Non-Clinical Performance:
    • Conforms to IEC 60601-1:2012 (Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance).
    • Conforms to IEC 60601-1-2:2007 (Electromagnetic compatibility).
    • Conforms to IEC 60601-2-18:2009 (Particular requirements for the basic safety and essential performance of endoscopic equipment).
    • Assessed as a Class 3R laser device with internal maximum Class 4 laser radiation according to IEC 60825:2007.
    • Animal testing (porcine model) validated in vivo fluorescence imaging capability.
  • Clinical Performance:
    • Clinical evaluation based on literature search and post-market surveillance adverse event information found continued clinical safety and performance.
    • Clinical study and case reports (Journal of Gastrointestinal Surgery, Surgical Innovation, Int! J Sur Case Reports) using the PINPOINT System support expanded Indications for Use.
    • No new concerns related to safety and effectiveness were introduced.

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not specified for clinical studies in this document. Animal testing used a "porcine model" (singular, but likely implying multiple animals or instances).
• Data Provenance:
  • Non-Clinical: Novadaq Technologies Inc. and accredited third-party laboratories.
  • Clinical: Clinical literature search, post-market surveillance (adverse event information), a clinical study, and case reports published in medical journals. The country of origin for the clinical data is not specified. It is likely retrospective for the literature review and post-market surveillance, and potentially prospective for the mentioned "clinical study," but this is not explicitly stated.

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

• Not specified. The document refers to clinical studies and case reports, which would typically involve medical experts, but details about ground truth establishment and expert qualifications are absent.

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

• Not specified.

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 mentioned. This device appears to be an imaging system intended for direct visualization by surgeons, not an AI-assisted diagnostic tool for interpretation by readers. The document highlights its use "to provide real time endoscopic visible and near-infrared fluorescence imaging" and "enables surgeons to perform minimally invasive surgery" and "visual assessment."

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

• Not applicable. This is an imaging system for direct surgeon use, not an algorithm. The "device is not intended for standalone use for biliary duct visualization" refers to its use in conjunction with white light and cholangiography, not to an algorithm's standalone performance.

7. The type of ground truth used

• Animal Testing: "In vivo fluorescence imaging capability" validated in a porcine model. This implies comparison against expected fluorescence patterns.
• Clinical Evaluation: Clinical literature and adverse event information. For the clinical study and case reports, the ground truth would typically be surgical outcomes, direct visualization during surgery, or other clinical assessments, but this is not explicitly detailed.

8. The sample size for the training set

• Not applicable as this is not an AI/machine learning device with a distinct training set. The device was "designed and developed."

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

• Not applicable (see above).

Summary of Missing Information:

The provided text is a 510(k) summary demonstrating substantial equivalence to predicate devices and conformance to general safety and performance standards. It lacks the detailed specifications of acceptance criteria, specific clinical study designs (e.g., sample sizes, ground truth establishment methods, expert qualifications, adjudication, MRMC studies) that would be present for a novel AI/algorithm-based diagnostic device. The performance data presented focuses on regulatory compliance, technological characteristics, and general safety/performance based on existing literature and animal models, rather than detailed quantitative performance metrics from controlled clinical trials against specific acceptance criteria.

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The Novadag Disposable Rigid Scope Introducer is intended to facilitate passage of a laparoscope through the anus allowing visual examination of the rectum and distal portions of the colon.

The single-use Disposable Rigid Scope Introducer is used in conjunction with a laparoscope to allow visual examination of the rectum and distal portions of the colon. When used with the laparoscope, the Disposable Rigid Scope Introducer and laparoscope are advanced into the rectum under visual guidance to a maximum insertion length of 25cm. An insufflation port is provided as part of the Endoscopic Introducer to allow insufflation of the rectum and lower colon.

The provided document does not contain information about specific acceptance criteria, a study proving device meeting acceptance criteria, or performance metrics. It is a 510(k) summary for a medical device (Disposable Rigid Scope Introducer) seeking substantial equivalence to predicate devices. The document outlines:

1. Device Description: The Novadaq Disposable Rigid Scope Introducer is a single-use device used with a laparoscope for visual examination of the rectum and distal colon, featuring an insufflation port.
2. Indications for Use: To facilitate the passage of a laparoscope through the anus for visual examination of the rectum and distal portions of the colon.
3. Predicate Devices: K092221 Colonic Splinting Overtube (US Endoscopy), K033954 Shape Locking Endoscopic Overtube (USGI Medical Inc.), K770291 Disposable Rigid Sigmoidoscope (Welch Allyn).
4. Technological Comparison: The device is considered similar to predicates in shape, materials, and effect on the patient. Differences include length (shorter than predicates) and the provision of an insufflation channel, similar to one predicate.
5. Nonclinical Tests: Safety and performance were verified by tests conducted by Novadaq Technologies and accredited third-party laboratories, adhering to ISO 10993-1:2009, ISO 8600-1 Second Ed., and ISO 8600-4 First Ed.
6. Clinical Performance Data: An "exhaustive literature search" was conducted via a written protocol, and the clinical evaluation report is based on clinical data from this literature review and an adverse events database. It states that this data "provide evidence that supports the safety and performance claims."
7. Safety & Effectiveness Conclusion: The submission claims that differences do not raise safety/effectiveness questions and the device is substantially equivalent to the referenced predicate devices.

Based on the provided text, I cannot complete the requested tables and information as the document does not include quantitative acceptance criteria, detailed study designs, sample sizes for test/training sets, expert qualifications, or ground truth establishment methods in the way a performance study report would.

The document states that "Data presented in the clinical evaluation report provide evidence that supports the safety and performance claims made for the Endoscopic Introducer," but it does not present that data or the methodology of the studies.

This is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing a detailed clinical study report with specific performance metrics and acceptance criteria for a novel algorithm or diagnostic device. For the types of information you're asking for (e.g., AUC, sensitivity, specificity, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance), a different type of document, such as a clinical study report or a more detailed section of the 510(k) itself (which is often proprietary and not included in the summary), would be necessary.

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

The SPY System consists of two components: the SP2001 Imaging Device and the SPY Pag. The SPY System utilizes the fluorescent imaging agent ICG. The SP2001 Imaging Device consists of an imaging head containing a camera, a laser light source, and a distance sensor attached to a mobile cart via an articulating arm. The mobile cart contains a flat panel monitor, a computer with keyboard and mouse, an electronics enclosure, and a printer. While ICG distributes through the vessels or tissues, absorption of laser light at 808 nm causes excitation of the ICG followed by emission of infrared energy at a wavelength of 830 nm. This results in a fluorescent image of the blood vessels and related tissue perfusion. A CCD camera with an 830 nm optical band-pass filter captures the images, Image sequences. up to 60 seconds in duration, are displayed on the monitor and recorded on the computer hard drive. The image sequences can be exported to a CD, DVD, memory stick or lpod. The camera head can be moved in the in horizontal plane during image sequence acquisition. Once the image is captured, the laser automatically shuts off.

Here's a breakdown of the acceptance criteria and the study information based on the provided 510(k) summary:

Acceptance Criteria and Device Performance Table:

It's important to note that this 510(k) summary does not explicitly state specific pass/fail acceptance criteria with numerical targets for the device's performance related to the proposed expanded indication (GI surgical procedures). Instead, it relies on demonstrating comparable performance to previously cleared indications and safety profiles. The performance reported is qualitative based on clinical utility and image quality.

Study Details:

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

   • Test Set Sample Size: Not explicitly stated as a numerical sample size for the current 510(k) submission's GI surgical procedures. The text refers to "All cases were conducted under the attending surgeons' medical judgment as part of the reconstructive clearance for the device. The examples are not meant to be all encompassing... but illustrate the safety and effectiveness of SPY imaging in this system throughout the GI tract from the esophagus to the anus." This suggests a collection of cases, but no specific number is provided.
   • Data Provenance: The studies were conducted on humans in various countries where the SPY System is commercially available (United States of America, Japan, Europe, Canada, Israel, and Russia). It's a combination of prospective and retrospective human experience since it refers to "over 10,000 surgical procedures in humans" and "This current 510(k) submission contains clinical performance data that support the use of the SPY System during GI surgical procedures. All cases were conducted under the attending surgeons' medical judgment as part of the reconstructive clearance for the device." This implies clinical use data rather than a dedicated, controlled prospective study for this specific indication expansion.

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

   • This information is not provided in the summary. The qualitative assessment of "utility," "safety," and "high quality images" appears to be based on the general judgment of "attending surgeons" and the reported experience in clinical use, rather than a formal ground truth established by a panel of independent experts for a specific test set.

3. Adjudication method for the test set:

   • This information is not provided. Given the nature of the data ("clinical utility" and "attending surgeons' medical judgment"), a formal adjudication method (like 2+1 or 3+1 consensus) for a specific test set does not appear to have been performed or described for this submission.

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 described as an intra-operative imaging system that provides images for visual assessment by surgeons, not an AI-assisted diagnostic tool that interprets images or improves human reader performance in a quantifiable MRMC study setup.

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

   • No, a standalone algorithm-only performance study was not done. The device's utility is explicitly stated as providing "fluorescence images for the visual assessment of blood flow," implying human interpretation is integral, not merely a supplemental step to an automated algorithm. The system is a medical device for imaging, not an AI diagnostic algorithm in isolation.

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

   • For the current GI indication, the "ground truth" is largely observational clinical utility and safety data from real-world surgical procedures, assessed by the attending surgeons, and general lack of adverse events. It is not framed as a formal ground truth established against a gold standard like pathology or long-term outcomes data in the context of a controlled study. For the original 510(k) (K042961), pig studies were used to demonstrate image quality, lack of thermal/physiological effects, but not explicitly linked to a "ground truth" in the diagnostic sense.

7. The sample size for the training set:

   • This information is not applicable/not provided in the context of this 510(k) summary. The SPY System is an imaging device, not a machine learning model that requires a "training set" in the traditional AI sense. Its underlying technology is optical fluorescence imaging. Previous clearances and extensive clinical use (over 10,000 procedures) serve as a broad "experience base" rather than a dedicated training set for an algorithm.

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

   • This information is not applicable for the same reasons as #7. There is no training set for a machine learning algorithm described in this submission.

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The SPY scope intra-operative imaging system (SPY scope) is intended to provide realtime endoscopic visible and near infrared fluorescence imaging. SPY scope enables surgeons to perform routine visible light endoscopic procedures as well as further visually assess vessels, blood flow and related tissue perfusion with near infra-red imaging during minimally invasive surgery.

The SPY® scope provides real-time high definition (HD) endoscopic video images of visible (VIS) and near infrared (NIR) indocyanine green (ICG) dye fluorescence during minimally invasive surgery. During such a procedure, the SPY scope functions like all conventional VIS light imaging systems used in surgical endoscopy. Visible light from the SPY scope light source illuminates the area of interest through the endoscope and the resulting reflected light is imaged by the SPY scope color HD camera and displayed on an HD video monitor.

The SPY scope device is comprised of the following components:

• Endoscopes for VIS and NIR illumination and imaging.
• A 3 CCD (charge coupled device) color video camera head with video coupler and accompanying sterile drape,
• Light source & video processor unit, and
• ICG imaging agent.

The provided text describes a 510(k) summary for the NOVADAQ SPY® scope Intra-operative Imaging System. It focuses on demonstrating substantial equivalence to predicate devices and detailing in vitro and in vivo testing for safety and effectiveness. However, it does not include acceptance criteria for device performance in terms of specific metrics (like sensitivity, specificity, accuracy) or a study explicitly designed to prove these criteria are met. The "testing" section is about validating the functionality and safety of the device, rather than a performance study against predefined metrics for clinical accuracy or efficacy.

Therefore, many of the requested items cannot be definitively answered from the provided text.

Here is a summary of what can be extracted and an indication of what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Test Set Sample Size:
  • In Vivo Testing: 6 dogs and 10 pigs.
  • Data Provenance: Prospective animal studies conducted at:
    • National Research Council of Canada, Winnipeg
    • University of Rochester, New York
    • Intuitive Surgical Inc. Sunnyvale, California
    • St Joseph's Translational Research Institute, Atlanta, Georgia
    • (Followed ethics approval by appropriate animal care committee).

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

• Not specified. The text mentions "The details of the imaging results varied depending upon the availability of complement and expertise," but it does not quantify the number or qualifications of experts involved in establishing ground truth for the animal studies.

4. Adjudication method for the test set

• Not specified. There is no mention of an adjudication method used for assessing the imaging results in the animal studies.

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, an MRMC comparative effectiveness study was not done. The device predates the common use of AI in medical imaging devices and the study described focuses on technical functionality and safety, not on human reader performance with or without AI assistance. The device is the imaging system.

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

• Not applicable / Not explicitly described as a standalone algorithm performance study. The SPY scope itself is an imaging system used by surgeons. The animal studies aimed to validate the system's ability to visualize different anatomical features using ICG fluorescence in real-time, which implies "human-in-the-loop" application (the surgeon/researcher interpreting the imaging output). There isn't a separate "algorithm-only" performance evaluation independent of human observation.

7. The type of ground truth used

• Direct observation / Known physiological characteristics: For the animal studies, the "ground truth" for blood flow, perfusion, and lymphatic drainage was based on the known physiological properties of ICG (rapid binding to plasma proteins, liver uptake, lymphatic uptake) and direct visualization of these processes through the SPY scope system as ICG circulated. The "successful imaging" of features like flow through arteries/veins, organ perfusion, biliary anatomy, and lymphatics serves as the validation, implying that the observed fluorescence corresponded to these known anatomical and physiological events. There's no mention of a separate gold standard like pathology or external outcomes data being used to validate the accuracy of the device's interpretation of those physiological events.

8. The sample size for the training set

• Not applicable. This device is an imaging system, not an AI or machine learning algorithm that requires a "training set" in the conventional sense. The "testing" sections describe validation of the device's optical and functional capabilities.

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 Analysis Toolkit is a separate companion software application to the SPY Intra-operative Imaging System and is intended as a display, analysis, and comparison tool for the interpretation of SPY images by trained healthcare professionals including cardiovascular, plastic & reconstructive, and organ transplant surgeons.

Note: The clinician retains the ultimate responsibility for making the pertinent diagnosis based on their standard practices and visual comparison of the separate images. The SPY Analysis Toolkit is a complement to the SPY procedures.

The SPY® Analysis Toolkit is a separate companion application to the SPY Intraoperative Imaging System's (SPY System) software, which is currently cleared for use in cardiovascular, plastic and reconstruction, and organ transplant surgeries. The Analysis Toolkit is capable of working cooperatively, as an accessory plug-in feature, with the SPY software or standalone on a physician's desktop computer. The Analysis Toolkit is not real-time.

Novadaq's SPY System allows surgeons (including cardiovascular, plastic and reconstructive, and transplant) to produce real-time images of blood vessels, surrounding tissue and related perfusion of those tissues/organs during various types of surgeries. The Analysis Toolkit provides a set of clinical image analysis tools and makes them available to clinicians for either intra-operative post image acquisition or retrospective analysis. The ultimate goal of analysis will be to provide surgeons with another parameter, in addition to standard of care information, including data from other imaging modalities, for use in pre-operative decision-making and post-operative evaluation of results as an input to post-operative care.

The SPY Analysis Toolkit is a plug-in module to the SPY Imaging Device and does not have any control over the device or the previously cleared software. The SPY Analysis Toolkit is an accessory software feature designed and developed to work with images acquired on the SPY System, models SP2000 and SP2001. The SPY Analysis Toolkit has no capability to modify in any way the underlying images previously acquired intraoperatively by the SPY System. The resolution and the quality of the images captured by the SPY System and analyzed by the SPY Analysis Toolkit remain the same.

The SPY Analysis Toolkit application is for viewing, manipulation, measurement and comparison of medical image sequences produced at single or multiple time-points by the SPY System. Entire image time-sequences are processed for viewing using a variety of analytical algorithms that provide visual or numerical results.

The Analysis Toolkit can also accept DICOM and AVI images independent of the SPY device for post-operative analysis.

The provided text describes the SPY Analysis Toolkit, its intended use, and its equivalence to predicate devices, but it does not contain information about specific acceptance criteria, a scientific study with a test set, or detailed performance metrics. The document is a 510(k) summary for regulatory clearance, focusing on demonstrating substantial equivalence rather than reporting on a clinical or performance study with acceptance criteria.

The "Testing" section mentions that the device was "designed and developed with the input from experienced SPY System users," and "scanned image datasets from the various disciplines were used as input for testing of the software functionalities in accordance with the Software Development Plan." It also states that "A full description of the software functionality, device hazard analysis, software requirements, and verification and validation protocols and testing can be found in Section 16 - Software, of this submission." However, these details are not provided in the excerpt.

Therefore, I cannot populate the table or answer most of the questions as the required information is not present in the provided text.

Here's a breakdown of what can be extracted or inferred from the given text:

1. Table of Acceptance Criteria and Reported Device Performance:

• Cannot be created. The document does not define specific acceptance criteria (e.g., sensitivity, specificity, accuracy targets) nor does it report specific performance metrics against such criteria. The document focuses on "substantial equivalence" to predicate devices based on intended use and technological characteristics rather than quantitative performance.

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

• Sample Size for Test Set: Not explicitly stated. The text mentions "Scanned image datasets from the various disciplines were used for testing," but no specific number or size of these datasets is provided.
• Data Provenance: Not explicitly stated. It mentions "datasets from the various disciplines," implying a medical context, but no country of origin is given. It is likely retrospective as it refers to "scanned image datasets."

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

• Number of Experts: Not specified.
• Qualifications of Experts: The device was "designed and developed with the input from experienced SPY System users," which included "all disciplines currently cleared to use the SPY System, in cardiovascular, plastic and reconstructive, organ transplant surgeries." This implies the "experts" were practicing surgeons in these fields. However, their specific role in establishing "ground truth" for a test set is not detailed.

4. Adjudication method for the test set:

• Not explicitly stated. The document does not describe any specific adjudication method for a test set.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

• No such study is described or referenced. The document indicates the SPY Analysis Toolkit is "a complement to the SPY procedures" and that "The clinician retains the ultimate responsibility for making the pertinent diagnosis based on their standard practices and visual comparison of the separate images." This suggests the tool is an aid, but no MRMC study or AI assistance effect size is mentioned.

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

• The document implies the software is not intended for standalone, unsupervised diagnosis. It explicitly states: "The clinician retains the ultimate responsibility for making the pertinent diagnosis based on their standard practices and visual comparison of the separate images." and "Device output and analysis is not real-time and is only used to indicate the appropriateness of a referral or surgical decision."

7. The type of ground truth used:

• Not explicitly stated. Given the context of a medical imaging analysis tool, ground truth would typically come from clinical diagnosis, pathology reports, or expert consensus, but the document does not specify.

8. The sample size for the training set:

• Not mentioned. The document refers to "scanned image datasets... used for testing," but does not distinguish between training and testing sets, nor does it provide sample sizes for either.

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

• Not mentioned.

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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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