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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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