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The Asimov-MKS Imaging System is indicated for fluorescence imaging of blood flow and tissue perfusion before, during, and after vascular, gastrointestinal, organ transplant, plastic, reconstructive, and micro surgeries.

The Asimov-MKS Imaging System is a fluorescence angiography imaging system. It is a prescription device intended to be used in hospital surgical suites, ambulatory surgery centers, and similarly equipped healthcare facilities. The Asimov-MKS Imaging System consists of an imager mounted to the distal end of an articulated arm that is affixed to a mobile cart.

Under the supervision of the surgeon, the imager illuminates a region of interested with near infrared and/or white light. Cameras, integral to the imager, acquire fluorescence and/or white light color images and direct the acquired images to processing hardware within the cart.

The articulated arm allows the imager to be directed at the region of interest. The arm affords unencumbered access to the patient and permits the cart to be positioned outside of the sterile field.

The cart allows the Asimov-MKS Imaging System to be positioned as needed for a surgical procedure and to be relocated within a facility for additional procedures or storage. The cart houses the processing hardware that display and record the acquired images. Software executed on the processing hardware provides secondary functions such as patient biographical data entry, image review, and data archive.

To maintain the sterile surgical field, a sterile drape covers the imager and portions of the arm during clinical use. The single use drape streamlines device cleaning after use.

The fluorescent imaging agent utilized is indocyanine green (ICG). ICG is injected into the patient's blood stream, rapidly binds to the blood plasma, and is transported on the blood from the injection point to the region of interest. The ICG fluoresces when illuminated with the near infrared light emitted by the imager. Images of the fluorescence allow the clinician to visually assess circulation and related tissue perfusion.

The provided text is a 510(k) summary for the Asimov-MKS Imaging System by OnLume Inc. It describes the device, its intended use, technological characteristics, and compares it to a predicate device (SPY Elite® Intraoperative Perfusion Assessment System). The document focuses on showing substantial equivalence to the predicate device primarily through technical specifications and adherence to safety standards.

However, the summary does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of AI/ML performance, human reader improvement with AI assistance, or the creation of ground truth using expert consensus or pathology. The provided text discusses the device's technical performance in terms of image acquisition, frame rates, and safety standards, but not its diagnostic or clinical performance in a way that would involve the detailed methodology described in your prompt (e.g., sample sizes for test/training sets, expert adjudication, MRMC studies).

The "Performance Data" section states: "Results of verification and validation testing performed by OnLume Inc. confirm the Asimov-MKS Imaging System conforms to design specifications and meets the needs of the intended users. Additionally, testing performed by an independent certified testing laboratory demonstrates the device complies with the requirements of applicable FDA recognized consensus safety standards for medical devices as listed in the following table." This explicitly refers to engineering and safety performance, not clinical diagnostic performance involving AI/ML and human-in-the-loop studies.

Therefore, I cannot populate the requested information based on the provided text. The document is about a hardware imaging system (fluorescence angiography) and its substantial equivalence to a predicate, not an AI/ML diagnostic algorithm that would require such extensive performance studies on clinical data.

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