LVivo Seamless

LVivo Seamless is a standalone medical image processing system that automatically analyzes ultrasound images to detect, measure, and calculate cardiac parameters for patients with suspected heart disease (age >18). The system accepts ultrasound exams in DICOM format, automatically selects appropriate clips for ejection fraction (EF) and global longitudinal strain (GLS) evaluation, and outputs results to a PACS system for clinician review.

The primary difference from the predicate device is the addition of the ability to activate FDA-cleared third-party software (TOMTEC) for automated EF and strain analysis, in addition to the existing LVivo EF and LVivo Strain modules. All other technological characteristics remain identical, including biplane EF evaluation, automated frame selection, manual adjustment capability, Simpson's method volume calculation, and Windows operating system.

Not stated in this summary.

The manufacturer argues substantial equivalence because the addition of third-party software capability does not alter the fundamental function, intended use, indications, or core algorithms of the device. Performance testing on 166 exams (139 with successful view identification) demonstrated comparable agreement between automated results and ground truth measurements—biplane EF correlation of 0.95 and GLS correlation of 0.92—meeting predefined success criteria. Since the new capability is simply an alternative analysis pathway with equivalent clinical performance, the modification does not introduce new safety or efficacy concerns.