(136 days)
The bioflux Device is intended for use by patients who either have or are at risk of having cardiac disease and those that demonstrate intermittent symptoms indicative of cardiac disease and require cardiac monitoring on a continuing basis for up to 30 days. The device continuously records ECG data and upon detection by an ECG analysis algorithm or manually initiated by the patient, automatically delivers the recorded cardiac activity to the server where it is presented and can be reviewed by a medical professional.
The data received from the bioflux device can be used by another device for arrhythmia analysis, reporting and signal measurements. The bioflux device is not intended to sound any alarms. The device does not deliver any therapy, administer any drugs, provide interpretive or diagnostic statements or provide for any life support.
bioflux is for prescription use only.
The bioflux system consists of the bioflux device and the server. The bioflux device is a portable, battery-powered, wireless cardiac monitor which may be worn by a patient to record ECG and activity level data for up to 30 consecutive days. The device can capture patient activated and auto-triggered events such as Bradycardia, pause and Atrial Fibrillation as identified by an embedded arrhythmia detection algorithm. The device is designed to automatically deliver the data to the server. The data is delivered to the server wirelessly via mobile cellular dedicated network connection. A medical professional, using the server, can adjust and program the device configuration and autotriggering parameters.
bioflux device is not a life-supporting or life-sustaining system. Clinical judgment and experience are used to check and interpret the data.
This document describes the BioFlux Device, a cardiac monitor. Since this device is a hardware device for monitoring and not an AI/ML algorithm for analysis, the typical acceptance criteria and study data provided in an AI/ML submission are not present.
However, I can extract information regarding overall performance testing and the product's intended function.
Here's a summary of the device's functional performance:
1. Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| ECG Signal Recording | Continuously records ECG signal. |
| ECG Data Storage | Stores ECG data in the device memory. |
| Event Transmission | Transmits manual or auto-activated event recordings to the server via mobile network connection. |
| Medical Professional Review Capability | Transmitted data can be evaluated by a medical professional. |
| Arrhythmia Detection (Algorithm) | Captures patient-activated and auto-triggered events such as Bradycardia, pause, and Atrial Fibrillation as identified by an embedded arrhythmia detection algorithm. |
| Server Functionality | Facilitates data communication, provides data storage, and presents data for evaluation. |
| Device Programming | Medical professional can adjust and program device configuration and auto-triggering parameters via the server. |
Study that proves the device meets the acceptance criteria:
The document mentions "Bench test results verify that Bioflux Monitor system can continuously record ECG signal, store ECG data in the device memory, and transmit manual or auto activated event recordings to the server via mobile network connection for evaluation by a medical professional. Test results verify that all requirements were met and that the Bioflux Monitor performs as designed."
2. Sample Size for Test Set and Data Provenance: Not applicable. The document describes bench testing for a hardware device, not a performance study involving a test dataset for an algorithm.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications: Not applicable. Ground truth for an algorithm's performance is not relevant for this type of hardware device submission.
4. Adjudication Method: Not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This is for assessing human reader performance with and without AI assistance, which is not relevant for this device.
6. Standalone Performance Study (Algorithm Only):
While there's an "embedded arrhythmia detection algorithm," the document describes the device as the subject of the performance testing, not the algorithm in isolation. The core function is recording and transmitting, with the algorithm being a part of how events are "auto-triggered." The performance verification focuses on the system's ability to record, store, and transmit, effectively implying that the algorithm's output (triggered events) are then transmitted. There isn't a dedicated standalone performance study for just the algorithm discussed in this document.
7. Type of Ground Truth Used: Not applicable in the context of an algorithm's performance. The "ground truth" for the device's functionality would be its physical capability to record, store, and transmit ECG data, which was verified via bench testing against design specifications.
8. Sample Size for the Training Set: Not applicable. This document does not describe the development or training of a machine learning algorithm.
9. How the Ground Truth for the Training Set Was Established: Not applicable.
§ 870.2920 Telephone electrocardiograph transmitter and receiver.
(a)
Identification. A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals.(b)
Classification. Class II (performance standards).