Trinias

The Trinias is an interventional fluoroscopic X-ray system using digital X-ray receptor panels for image acquisition. It is intended for diagnostic imaging and interventional procedures including cardiac angiography, neurovascular angiography, abdominal angiography, peripheral angiography, rotational angiography, multi-purpose angiography, and whole body radiographic/fluoroscopic procedures.

Both the predicate and proposed devices have the same technological characteristics in design, material, chemical composition, and principle of operation. The modified device includes the new SCORE Opera software feature that uses AI (deep learning) filter technology for noise suppression and contrast enhancement to improve visibility of devices under low dose conditions.

The software was developed and tested in accordance with FDA Guidance Documents: Content of Premarket Submissions for Device Software Functions, Guidance for Industry and FDA Staff, Cybersecurity in Medical Devices, and Quality System Considerations. The device is subject to ISO 13485 design controls, nonconforming product procedures, and corrective/preventative action requirements.

The indications for use are identical to the predicate device. The modified device provides improved image processing through SCORE Opera software without changing the fundamental design or intended use. Non-clinical testing and clinical image quality studies confirmed the AI-enhanced device is as safe and effective as the predicate and does not present new safety issues.