SurgiCount+ System

The SurgiCount+ System is designed to improve surgical safety and patient care by providing adjunctive tools for blood loss estimation and surgical sponge management. It achieves this through a combination of AI-powered image analysis for hemoglobin quantification on sponges, RFID technology for accurate sponge tracking, and gravimetric measurement for quantitative blood loss assessment.

The SurgiCount+ System is a multifunctional software application designed to assist clinicians in estimating external blood loss and managing surgical sponges and other absorbent materials during medical procedures. It integrates three primary software configurations: Triton AI, SC+ Sponge Counting, and Triton QBL, along with combined workflows (SC+ AI and SC+QBL) to cater to varied clinical needs requiring both blood loss estimation and absorbent item tracking. The system utilizes accessories including an iPad Pro, RFID-tagged surgical items, an RFID reader, and a Bluetooth-enabled scale. The Triton AI configuration employs a proprietary AI algorithm, trained through machine learning, to analyze images of surgical sponges captured by a mobile device, estimating hemoglobin mass and thereby blood volume. The SC+ Sponge Counting configuration, also enhancing the Triton AI module, utilizes UHF RFID technology to scan, count, and locate tagged absorbent articles, improving upon manual counting processes. The Triton QBL configuration uses a scale to weigh absorbents for fluid volume calculation. Performance validation demonstrated high accuracy for the hemoglobin algorithm (within ±1.99 g Hb), a low failure rate for sponge recognition (0.19%), and compliance with electromagnetic compatibility and wireless coexistence standards. Human factors validation confirmed the system's usability and safety.

AI Regulatory Concerns

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Jev reads the full FDA letter and returns calibrated concern probabilities per regulatory category. These are AI estimates, not regulatory advice.

• Q1. How does the AI algorithm differentiate between blood and other fluids (e.g., saline, irrigation fluid) on surgical sponges to ensure accurate hemoglobin mass estimation?; What is the specified range and accuracy of the RFID reader for locating tagged sponges within a complex operating room environment, particularly if sponges are obscured or within the surgical site?; Can the system integrate with existing hospital electronic health record (EHR) systems for seamless data transfer of blood loss estimations and sponge counts?; What are the limitations of the Sponge Recognition Algorithm (SRA) concerning different types, sizes, or conditions (e.g., heavily saturated, folded) of surgical sponges not specifically validated?; How does the system account for variability in baseline patient hemoglobin levels when calculating blood volume from the estimated hemoglobin mass on sponges, and what is the impact of incorrect user-entered patient Hb values?