PeriCALM Patterns 3.0
PeriGen, Inc.PeriCALM Patterns 3.0 is an AI-based software tool designed to assist clinicians in monitoring fetal well-being during pregnancy and labor. It analyzes fetal heart rate and uterine contraction signals, automatically identifying patterns such as accelerations, decelerations, baseline heart rate, and contractions. This information supports clinical decision-making for pregnant patients at or beyond 32 weeks of gestation by providing annotated summaries of the fetal monitor recordings.
Intended Use
Provides additional secondary information as an adjunct to qualified clinical decision-making during antepartum or intrapartum obstetrical monitoring at ≥32 weeks gestation for annotation and summary of fetal heart rate recording and uterine pressure recording for contractions.
Technology
Software uses Long and Short-Term Memory (LSTM) neural networks to identify segments of fetal heart rate tracing corresponding to accelerations, decelerations, baseline, and uninterpretable segments. Contraction detection uses similar processes as its predicate device. It imports fetal monitor data via interfaces and can operate networked or standalone.
Performance
Software underwent risk analysis, requirements review, design review, verification, and validation per FDA guidance. Clinical performance tested via retrospective multi-reader/multi-case study comparing AI results to expert panel ground truth and clinician readers for ≥32 weeks gestation. AI performance was non-inferior and met all acceptance criteria for detection of fetal heart rate accelerations, decelerations, and baseline measurements.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
4/12/2024
9 months - 2
FDA Approval
1/10/2025
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