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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:

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.

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Bioflux software is intended to be used to analyze, view, and report ECG data acquired from a variety of ECG sources including single and 3-lead ECG devices. Bioflux software is operated locally in a browser and data is accessed via the users' credentials on the hardware platform running the browser.

It will be used by cardiologists, general practitioners, cardiac, or ECG technicians, nurses, monitoring service technicians, and other cardiac related institutions, or care givers, in independent clinical testing facilities, clinics, hospitals, physician's offices, or anywhere a physician or qualified non-physician practitioners deems appropriate

Bioflux software does not offer diagnosis, or medical alarms. It is intended that competent human intervention be involved before any impact on health occurs. Clinical judgement and experience are used to check and interpret the data.

Bioflux software is an API based ECG viewer software that can display ECG records and provide tools for trained clinicians to analyze those ECG recordings. It is utilized by manually opening up ECG files of supported formats into the viewer.

Bioflux software fulfills all of the following:

• It is a cardiology software product, delivered on disk using the Single Page Application model.
• It operates on 2015 or later versions of Chrome and Firefox browsers.
• The data can be opened manually or entered via keyboard, mouse or touchscreen whereupon it gets sent to the browser for viewing analysis and storage.
• Information can be displayed on the display or printed via the browser.

Bioflux software is not a life-supporting or life-sustaining system. Clinical judgment and experience are used to check and interpret the data.

The provided text does not contain detailed information about specific acceptance criteria related to a device performance study. Instead, it focuses on the Bioflux software's compliance with general standards and its substantial equivalence to a predicate device.

However, based on the information describing the performance testing and compliance with standards, we can infer some general acceptance criteria for the functions the Bioflux software is intended to perform.

Here's an attempt to structure the information based on your request, acknowledging the limitations of the provided text:

Acceptance Criteria and Study for Bioflux Software

The Bioflux software is an API-based ECG viewer software intended to analyze, view, and report ECG data. The study primarily focused on demonstrating compliance with relevant industry standards and ensuring the software performed its intended functions in its specified operating environments.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the exact sample size used for the test set. It mentions "scenario validations, algorithm confirmation testing, and device functional testing," which implies that various test cases and data were used, but the quantity is not provided.

The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. Given the nature of a software viewer that processes existing ECG data, it is likely that existing (retrospective) ECG datasets were utilized for testing, but this is not confirmed.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

The document does not provide any details regarding the number of experts used or their qualifications for establishing ground truth for the test set. The Bioflux software is described as not offering diagnosis or medical alarms, and that "competent human intervention be involved before any impact on health occurs" and "Clinical judgement and experience are used to check and interpret the data." This suggests that human expert interpretation is crucial in the real-world use of the device, but it doesn't detail how ground truth was established during testing for its performance. The testing primarily focused on compliance with technical standards for ECG data processing and display, not on diagnostic accuracy against expert ground truth.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the test set. The performance testing section mentions "predetermined acceptance criteria were met," which implies that the outcomes of the tests were evaluated against these criteria, but not necessarily through an adjudication process by multiple experts for diagnostic accuracy.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or at least not reported in this 510(k) summary. The summary focuses on the device's technical compliance and substantial equivalence to a predicate, not on improvements in human reader performance with or without AI assistance. The Bioflux software is described as a viewer and analysis tool that "does not offer diagnosis, or medical alarms," emphasizing human intervention for interpretation.

6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) Was Done

The document does not describe a standalone study in the context of diagnostic accuracy or a specific algorithm's performance without human-in-the-loop. The "algorithm confirmation testing" mentioned in the performance section suggests internal testing of software algorithms, but this is distinct from a standalone diagnostic performance study. The device's primary function is to display and analyze data for human interpretation.

7. The Type of Ground Truth Used

Given that the performance testing focused on compliance with technical standards for ECG data handling, display, and measurement (AAMI EC11, AAMI EC38, IEC 60601-2-25, IEC 60601-2-47), the "ground truth" for the software's technical performance would likely have been established through:

• Reference standards and specifications: Each standard defines specific technical requirements for ECG devices.
• Known input data: During "algorithm confirmation testing" and "scenario validations," the software would be fed with known ECG data (e.g., simulated, annotated) to verify correct processing and output.
• Manual verification: For display accuracy and measurement tools, human verification against the known input would likely serve as the ground truth.

There is no mention of expert consensus, pathology, or outcomes data being used to establish ground truth for the performance testing described.

8. The Sample Size for the Training Set

The document does not specify a training set size. As the Bioflux software is described as an "ECG viewer software" that provides "tools for trained clinicians to analyze those ECG recordings" and "does not offer diagnosis, or medical alarms," it implies that it's not an AI/ML diagnostic algorithm that would typically have a distinct "training set" in the conventional sense. Its functionality is to display and provide measurement tools for existing ECG data based on predefined standards and algorithms, rather than learning from data to make predictions or classifications.

9. How the Ground Truth for the Training Set Was Established

Since there is no mention of a training set for an AI/ML model, the concept of establishing ground truth for a training set is not applicable based on the provided information. The device functions as a data display and analysis tool guided by established medical device standards.

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