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510(k) Data Aggregation
(440 days)
Everion+ System
Everion+ provides continuous monitoring of the following vital signs in adults, 18 years of age or older, when at rest:
- Pulse rate
- Respiration rate
- Movement
The data from Everion+ is intended to be used in a hospital or home environment in order to support monitoring of wearers under the care of a trained healthcare professional. Everion+ is not intended for use in a critical care environment such as an ICU or operating room. The device information should not be the sole basis for clinical decisions.
The Everion+ is a wireless multi-parameter vital-signs monitoring system. The Everion+ was includes an Application Programming Interface (API), which is intended to allow development of user interface applications that enable clinicians and medically-qualified personnel to access recorded vital signs information for active patient monitoring.
The system is comprised of the following components:
- Wearable device with multiple sensors
- Secure cloud environment with an API .
- Charger with accessories .
- Armband .
The Everion+ wearable is battery-operated with integrated sensors and wireless transceiver. The wearable is worn on the upper arm via the adjustable armband that snaps to it. The armband is made of a stretchy material and has an adjustable clip to enable fitting to most adults. The wearable continuously gathers multi-parameter vital signs data from the person being monitored and securely transmits the data to the server component of the system, via cellular communication, when in range of a third-party receiver.
Here's a breakdown of the acceptance criteria and study information for the Everion+ System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Parameter | Acceptance Criteria (Objective) | Reported Device Performance (Result) |
---|---|---|
Pulse Rate (PR) | RMSE ≤ 3 bpm | RMSE ≤ 3 bpm (met) |
Respiration Rate (RR) | RMSE |
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