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Upon intravenous administration and use of an ICG (Indocyanine green for Injection) consistent with its approved label, the EXPLORER AIR® II is used in capturing fluorescent images for the visual assessment of blood flow and tissue perfusion, before, during, and after vascular, gastrointestinal, organ transplant, and plastic, micro- and reconstructive surgeries. The EXPLORER AIR® II is indicated for use in adult and pediatric patients one month of age and older.

Upon administration and use of pafolacianine consistent with its approved labeling, the EXPLORER AIR® II is used to perform intraoperative fluorescence imaging of tissues that have taken up the drug.

EXPLORER AIR® II consists of an imaging system that contains two cameras (one (1) for fluorescence, one (1) for color images) suspended by an articulated arm attached to a trolley. A touch screen and secondary monitor are also mounted on the trolley.

EXPLORER AIR® II enhances the surgeon's vision with use of near infrared fluorescence (NIR) imaging. The technology is based on the exposure of the tissue of interest to light after fluorescent dye such as indocyanine green (ICG) or pafolacianine has been administered to the patient. The EXPLORER AIR® II visualizes fluorescence excited by infrared light (740-760nm) and emitted in the band around 800nm. After image acquisition, the composite image (overlay of fluorescence and color images) is displayed along with the fluorescent and color images. The user can tag and compare images, play the recorded videos, and export the selected files.

The EXPLORER AIR® II must be used with EXPLORER AIR® Sterile Drape for use under sterile conditions.

The provided text is a 510(k) premarket notification for the EXPLORER AIR® II device. It primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device (K222240) rather than presenting a de novo clinical study with detailed acceptance criteria and performance data for a novel AI/software component.

Therefore, the information required to fully answer your request (acceptance criteria, study details like sample size for test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) is not present in the provided document.

The document states:

• "No clinical tests were conducted to support this submission."
• The primary argument for clearance is that the device is "substantially equivalent" to its predicate due to "minor differences for HW design 2.2 (due to manufacturability and EOL of certain components), Packaging 2.0 (same materials, improvements for repacking in case of service), and SW 2.2 (OTS updates, image visualization improvements, and removal of alignment step by the user prior to every procedure)."
• It mentions "Software verification and validation testing were updated and conducted" to meet FDA guidance, but it does not provide the specific acceptance criteria or the results of these tests in a detailed manner.

In summary, this document describes a submission based on substantial equivalence and non-clinical testing (software verification and validation), not a performance study of an AI algorithm with specific acceptance criteria and detailed clinical study results as you've requested.

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