SurgiCount+ System
Stryker InstrumentsThe SurgiCount+ System by Stryker Instruments is a multifunctional software application designed to assist clinicians in estimating blood loss during surgery by analyzing images of used surgical sponges. It uses AI algorithms to estimate hemoglobin mass and blood volume on sponges and incorporates RFID technology to count and locate surgical sponges, improving surgical item management and patient safety.
Intended Use
The SurgiCount+ System Software is a multifunctional software application intended to be used as an adjunct in the estimation of blood loss and management of surgical sponges and other absorbent items.
Technology
The system includes three software configurations using AI image analysis to estimate hemoglobin mass on surgical sponges and RFID technology to scan, count, and locate RFID-tagged sponges, using a mobile device camera and Bluetooth-enabled scale with proprietary AI algorithms.
Performance
Validation included software verification and extensive bench testing confirming AI accuracy in hemoglobin mass estimation within acceptable limits, sponge recognition failure rate below threshold, electromagnetic compatibility, wireless coexistence testing, and human factors validation demonstrating safety and effectiveness.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
7/28/2023
5 months - 2
FDA Approval
1/11/2024
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