prolaio eVO2peak Module (Version 1.0)

The prolaio eVO2peak Module is a software-only device that estimates peak oxygen consumption (VO2peak) in adults by analyzing single-lead ECG and accelerometry data from wearable sensors during daily activities. It provides an adjunctive cardiovascular status indicator for clinicians to use alongside other clinical findings, not as a standalone diagnostic or real-time monitoring tool.

The device is a Python library software that processes stored physiologic data using a locked deep-learning model trained on cardiopulmonary exercise test (CPET) reference data. Unlike the predicate (CipherOx CRI M1), which continuously monitors SpO2 and pulse rate using a finger-worn pulse oximeter, the eVO2peak Module estimates VO2peak from chest-worn ECG and accelerometry inputs in ambulatory settings rather than hospital/prehospital settings.

ISO 14971 (risk management), IEC 62304 (software V&V), IEC 62366 (human factors engineering), FDA's 2023 Cybersecurity Premarket Guidance, FDA's Good Machine Learning Practice (GMLP) principles, and FDA's 2016 guidance on applying human factors to medical devices.

Both devices are Class II adjunctive cardiovascular status indicators (21 CFR 870.2200, product code PPW) for adult populations that estimate clinical physiologic parameters without serving as diagnostics, alarms, or active monitoring tools. They share the same regulatory classification, software-based approach, non-invasive biosensor inputs, and use by qualified medical professionals for retrospective clinical evaluation, demonstrating substantial equivalence despite different measurement parameters and sensor modalities.