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The PDE is an imaging system used in capturing and viewing fluorescent images for the visual assessment of blood flow as an adjunctive method for the evaluation of tissue perfusion, and related tissue-transfer circulation in tissue and free flaps used during plastic, micro-, reconstructive and organ transplant surgeries.

The PDE is an imaging system used in capturing and viewing fluorescent images for the visual assessment of blood flow as an adjunctive method for the evaluation of tissue perfusion, and related tissue-transfer circulation in tissue and free flaps used during plastic, micro-, reconstructive and organ transplant surgeries. The PDE is intended for intraoperative visual assessment of blood vessels and related tissue perfusion, by enabling surgeons to observe fluorescent images of blood vessels and related tissue perfusion. Indocyanine green (ICG) is injected intravenously into patients. Infrared light-emitting diodes (LEDs) are used to excite the fluorescence of ICG and illuminate the regions of a patient's body to be observed. A charge coupled device (CCD) camera captures the fluorescent image that is used to assess the blood vessels and related tissue perfusion. The PDE consists of the following components: Camera Unit, Controller, and Remote Controller. The Camera Unit contains a CCD camera and LED light sources and is used either by hand or attaching it to a mechanical arm. The Controller receives the video signal of the fluorescent image from the Camera Unit and outputs the processed fluorescent image to the external video monitor and recorder. Adjustments of the fluorescent image are possible either by the Camera Unit or the Remote Controller.

The provided document describes a 510(k) submission (K110480) for the Hamamatsu Photonics K.K. PDE device, a fluorescent angiographic system. This device is an imaging system used for the visual assessment of blood flow as an adjunctive method for evaluating tissue perfusion and related circulation in certain surgical contexts.

However, the document does not contain the detailed information typically found in a clinical study report that would allow for a comprehensive description of acceptance criteria and a study proving the device meets those criteria, especially in the context of an AI/human-in-the-loop system.

Instead, the submission primarily focuses on establishing substantial equivalence to predicate devices (Novadaq Technologies Inc.'s SPY Imaging System SP2000 and SPY Fluorescent Imaging System SP2001) based on:

• Identical intended use, indications for use, and principles of operation.
• Similar technological characteristics.
• Safety and efficacy confirmation through Hamamatsu's testing and validation activities.

The "Performance data" section lists the following as having been conducted:

1. Electrical per IEC 60601-1.
2. Electromagnetic Compatibility per IEC 60601-1-2.
3. Light Emitting LED Product per IEC 60825-1 (Class1 LED product).
4. Clinical use in Japan for 5 years without adverse events and a review of published literature.

This submission is for a medical imaging device, not an AI algorithm, and therefore the types of studies and acceptance criteria (e.g., MRMC, standalone algorithm performance, ground truth establishment by experts, adjudication methods) relevant to AI-based medical devices are not detailed.

Therefore, based only on the provided text, I cannot complete a table of acceptance criteria and reported device performance, nor can I describe study specifics like sample size for test sets, number of experts, adjudication methods, MRMC studies, or specific ground truth methodologies in the way you've outlined for an AI-centric study.

The document does mention "clinical tests" and states that "All tests demonstrate that the device functions as intended," and refers to "a review of the published literature" and 5 years of clinical use in Japan. However, these are high-level statements and do not provide the granular detail required for your request.

Summary of what can be extracted from the document regarding "proof" the device meets criteria (though not in the requested format):

• Acceptance Criteria (Implied):
  • Compliance with electrical safety (IEC 60601-1).
  • Compliance with electromagnetic compatibility (IEC 60601-1-2).
  • Compliance with LED product safety (IEC 60825-1, Class 1).
  • Functioning as intended for visual assessment of blood flow for tissue perfusion (based on substantial equivalence and lack of adverse events in 5 years of clinical use in Japan).
  • Being at least as safe and effective as predicate devices.
• Reported Device Performance (Implied from the text):
  • "All tests demonstrate that the device functions as intended."
  • "The PDE has been sold and used clinically for 5 years in Japan without any adverse events."
  • "A review of the published literature concludes that the device worked as intended by safely assessing the blood flow and related tissue perfusion during surgeries."
  • The FDA's determination of "substantial equivalence."

In conclusion, the provided 510(k) summary focuses on demonstrating substantial equivalence and compliance with general safety and performance standards for a traditional medical device, not on specific AI algorithm performance metrics or study designs typically employed for AI/ML-based medical devices.

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