(59 days)
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 and viewing 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.
EXPLORER AIR® II is a fluorescence imaging system, which enables users to visually assess blood flow to evaluate tissue perfusion and tissue-transfer circulation. It can be used on any part of the body during plastic, reconstructive, gastrointestinal, and organ transplant surgeries. 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) has been administered to the patient. The EXPLORER AIR® II visualizes fluorescence excited by infrared light (740-760nm) and emitted in the band centered 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 provided text describes the regulatory clearance of the EXPLORER AIR® II device by the FDA. It outlines the device's intended use, technological characteristics, and comparisons to a predicate device (SPY Elite Intraoperative Perfusion Assessment System). However, it does not contain the detailed information required to describe specific acceptance criteria for AI/ML performance, nor a study design with a test set, ground truth experts, or MRMC study results.
The document discusses performance data related to:
- Electrical safety and electromagnetic compatibility (EMC)
- Photobiological safety
- Verification of optical, mechanical and functional requirements (including fluorescent performance, physical properties, environmental conditions, optical requirements, design/ergonomics, usage requirements, power supply, data export, mechanical restrictions)
- ICG (Indocyanine green) testing for detection capability and limit of detection
- Human factors validation
- Software verification and validation testing
While these are performance tests, they are focused on the hardware, general functionality, and safety of the imaging system itself, rather than an AI/ML algorithm's diagnostic or prognostic performance in assessing blood flow and tissue perfusion from the images. The device's function is described as "capturing and viewing fluorescent images for the visual assessment of blood flow and tissue perfusion," indicating that the visual assessment is primarily done by the human user. The software section mentions that a malfunction could lead to a delay in care if the physician were to rely on EXPLORER AIR® II instead of performing a visual assessment, implying the device is an assistive tool for visual assessment, not an automated diagnostic AI.
Therefore, I cannot extract the requested information about AI model acceptance criteria, test sets, expert ground truth, or MRMC studies from this document. The device described appears to be a medical imaging system that facilitates visual assessment by a human, not an AI/ML software as a medical device (SaMD) that performs automated analysis or provides diagnostic output based on AI.
To answer your request based on the provided text, I must state that the document does not contain the information about an AI/ML component's performance study as described in your prompt.
§ 892.1600 Angiographic x-ray system.
(a)
Identification. An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.