(28 days)
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
| Acceptance Criteria Category | Specific Criteria (Inferred from Standards & Description) | Reported Device Performance |
|---|---|---|
| ECG Data Handling & Display | Compliance with AAMI EC11 (Diagnostic Electrocardiographic Devices) | The Bioflux device was tested and complies with AAMI EC11. This suggests accurate display of ECG traces, appropriate speed/gain/filter values, and perhaps other display characteristics for diagnostic ECGs. |
| Ambulatory ECG Data Handling | Compliance with AAMI EC38 (Ambulatory Electrocardiographs) | The Bioflux device was tested and complies with AAMI EC38. This indicates its capability to handle and display data specifically related to ambulatory ECGs. |
| ECG Measurement & Analysis | Compliance with IEC 60601-2-25 (Particular requirements for the basic safety and essential performance of electrocardiographs) | The Bioflux device was tested and complies with IEC 60601-2-25. This implies the system meets safety and performance requirements for basic electrocardiographs, potentially including accurate interval measurements (RR, PR, QRS, QT, QTc) and general signal processing. |
| Ambulatory ECG Safety & Performance | Compliance with IEC 60601-2-47 (Requirements for the basic safety and essential performance of ambulatory electrocardiographic systems) | The Bioflux device was tested and complies with IEC 60601-2-47. This indicates compliance with safety and essential performance standards specifically for ambulatory ECG systems, supporting its ability to reliably process and present such data. |
| Beat Caliper Measurements | ECG Viewer will include Beat Caliper measurements in standard ECG intervals (RR, PR, QRS, QT, QTc) | Yes. The software supports beat caliper measurements for standard ECG intervals. |
| ECG Trace Display & Controls | ECG viewer will display ECG traces, as well as speed, gain, and filter values. | Yes. The software displays ECG traces and relevant parameters. |
| Software Functionality & Reliability | Verification and validation activities related to device modification | "Verification and validation activities related to the device modification were performed on the applicant device, and the predetermined acceptance criteria were met in all cases." This indicates successful functional testing, scenario validations, and algorithm confirmation testing within the software. |
| Browser Compatibility | Operate on targeted web browsers (Chrome, Firefox) | The software was verified in both Firefox and Google Chrome operating environments, confirming its compatibility and functionality within these browsers. |
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.
§ 870.2800 Medical magnetic tape recorder.
(a)
Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.(b)
Classification. Class II (performance standards).