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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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