(119 days)
Bioflux Software II is intended to be used to view and annotate data acquired from diagnostic ECG sources of 1 to 3leads. Bioflux Software II is operated in a web browser and data is accessed via the users' credentials on the hardware platform running the web browser. It will be used by cardiologists, general practitioners, cardiac, ECG technicians, nurses, monitoring service technicians, and other cardiac related institutions.
Bioflux Software II will be used in independent clinical testing facilities. clinics, hospitals, physician's offices, or anywhere a physician or qualified practitioners deem appropriate.
Bioflux Software II 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 II is a browser based ECG viewer software that displays ECG records and provides tools for trained clinicians to annotate (store, retrieve and report) those ECG recordings. It is utilized by manually opening ECG files of supported formats or through an API that allows for third parties to integrate their devices and directly push ECG files into the viewer.
Bioflux Software II fulfills all of the following:
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- It is a cardiology software product, running locally in a browser.
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- Bioflux Software II operates on 2018 or later versions of Chrome and Firefox browsers.
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- The data can be opened manually or entered via keyboard, mouse or touchscreen where upon it gets opened in the browser for viewing and storage.
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- Information can be displayed on the computer monitor or printed on paper using the web browser.
The Bioflux Software II is an ECG viewer intended to view and annotate data acquired from diagnostic ECG sources of 1 to 3-leads. It does not offer diagnosis or medical alarms, and competent human intervention is required.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Compliance with AAMI EC11 standard | Complies with AAMI EC11 standard |
| Compliance with AAMI EC38 standard | Complies with AAMI EC38 standard |
| Compliance with IEC60601-2-25 standard | Complies with IEC60601-2-25 standard |
| Compliance with IEC60601-2-47 standard | Complies with IEC60601-2-47 standard |
| Operates in Firefox browser | Verified in Firefox browser |
| Operates in Google Chrome browser | Verified in Google Chrome browser |
| Scenario validations meet pre-determined acceptance criteria | Met pre-determined acceptance criteria |
| Beat marker confirmation testing meets pre-determined acceptance criteria | Met pre-determined acceptance criteria |
| Device functional testing meets pre-determined acceptance criteria | Met pre-determined acceptance criteria |
2. Sample Size for Test Set and Data Provenance
The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It simply states that "Verification activities related to the device modification were performed on the applicant device."
3. Number of Experts and Qualifications for Ground Truth
The document does not provide information on the number of experts used to establish the ground truth for the test set or their qualifications. Given that the device is an ECG viewer for annotation and does not offer diagnosis or alarms, it's possible that the "ground truth" for functional testing related to viewing and annotation capabilities would be based on expected software behavior rather than expert clinical consensus on diagnoses.
4. Adjudication Method for the Test Set
The document does not mention any adjudication method (e.g., 2+1, 3+1) for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. The device is a viewer and annotator, not a diagnostic aid that would assist human readers in interpretation. The goal of the study was to verify the software's functionality and compliance with standards, not to evaluate improvements in human reader performance with AI assistance.
6. Standalone Performance Study
A standalone performance study was done for the device in the sense that the listed performance criteria (compliance with standards, scenario validations, beat marker confirmation, device functional testing) were performed directly on the "applicant device" (Bioflux Software II) and its operating environments (Firefox and Chrome). This verifies the algorithm's functionality and compliance without human-in-the-loop performance evaluation in a diagnostic context.
7. Type of Ground Truth Used
The type of ground truth used appears to be expected software behavior and compliance with technical standards. The verification activities focused on functional aspects like "scenario validations," "beat marker confirmation testing," and "device functional testing" in the context of specified ECG viewing and annotation capabilities. This contrasts with diagnostic devices where ground truth might be established by expert consensus on clinical findings, pathology, or outcomes data.
8. Sample Size for the Training Set
The document does not mention a training set. This is consistent with the device being primarily an ECG viewer and annotation tool, rather than a machine learning model that requires a training set for algorithm development.
9. How Ground Truth for the Training Set Was Established
As no training set is mentioned or implied for this device, the method for establishing ground truth for a training set is not applicable.
§ 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).