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The Biotres is indicated for use on adult patients 18 years or older who may be asymptomatic or who suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light headedness, pre-syncope, syncope, fatigue, chest pain and/or anxiety and may require cardiac recording on a continuous basis for up to 30 days. The signal acquired by the Biotres is not intended and should not be used for automated or semi-automated analysis.

The Biotres system consists of 1) the Biotres Recorder, 2) a dedicated Biotres AC wall charger, 3) Biotres Gateway application for use on mobile devices using Android or iOS, and 4) Biotres Configured Secure Server. The Biotres Recorder is an ECG recording only device and does not include ECG analysis, alarms and is not a real time ECG monitor. The Biotres recorder is a small, lightweight, ambulatory, reusable 3 channel ECG recorder that is placed on the center of the chest. The Biotres Recorder has two buttons: 1) power button and 2) patient event marking button. There is an LED "status indicator light" in the middle of the patient event marking button that provides recorder status indications. The Biotres Recorder attaches to the patient's chest through three standard commercially available ECG electrodes. Biotres includes a Bluetooth modem to communicate with the Biotres Configured Secure Server through the Biotres Gateway Application. The Biotres Recorder integrated memory can store up to 30-days of ECG data. This data can be uploaded by the clinician to the Biotres Configured Secure Server. The dedicated Biotres AC Wall charger is used to charge the Biotres Recorder daily when disconnected from the patient. The ECG recorded data is transferred via the Biotres Gateway App via a Bluetooth connection and subsequently to the Biotres Configured Secure Server. Clinicians can use the Biotres Gateway Application using their privileged login credentials to connect Biotres Recorders to the Biotres Configured Secure Server so that patient studies may be started and completed. The Biotres Gateway Application can be used by the patient once registered (nonprivileged login credentials) and the patient can use the application to monitor the status indicators of the Biotres Recorder and to enter symptoms if the Event Marking Button is pressed on the recorder. The ECG recorded data from the Biotres Recorder can be transferred, by the clinician, from the Biotres Configured Secure Server when the recorder is connected to the Biotres Gateway App at the end of a patient study. The Biotres Configured Secure Server is an SFTP server that is configured to work with the Biotres System. The server enables the Clinician, through secured login, to command the Biotres Recorder (e.g. initiate ECG data collection) and to access uploaded MIT16 ECG data recordings when the ECG data collection is complete. Biotres does not provide the patient or clinician with diagnostic or interpretive statements based on the ECG data. Biotres ECG recordings can be viewed through the Bioflux Software II (K201040) by qualified medical personnel.

The provided text is a 510(k) summary for the Biotres device. It describes the device, its intended use, and compares it to a predicate device to establish substantial equivalence. However, this document does not contain the detailed clinical study information typically found when proving a device meets specific acceptance criteria through performance data.

The crucial piece of information for your request is that the Biotres device is not an AI or algorithmic analysis device. The text explicitly states: "The signal acquired by the Biotres is not intended and should not be used for automated or semi-automated analysis." Its purpose is to record ECG data for up to 30 days, which is then to be reviewed and interpreted by qualified medical personnel using an ECG viewer software.

Therefore, the concepts of acceptance criteria for algorithmic performance, sample sizes for AI test sets, expert ground truth establishment for AI, MRMC studies, or standalone algorithm performance do not apply to this device as described.

The performance testing mentioned (IEC 60601-2-47:2012) is a standard for basic safety and essential performance of ambulatory electrocardiographic systems, which typically involves testing electrical safety, signal quality, and functional parameters, not the accuracy of an AI algorithm in detecting or classifying conditions.

Given this, I cannot fill in the requested table and details for the points related to AI/algorithmic performance because the device, as described, does not perform automated or semi-automated analysis that would require such validation.

However, I can provide what is present in the document.

Based on the provided document, the Biotres device is a medical magnetic tape recorder (ECG recorder) and explicitly states it is NOT intended for "automated or semi-automated analysis." Therefore, the detailed acceptance criteria and study proving algorithmic performance (as typically seen in AI/ML medical devices) are not applicable or present in this 510(k) summary.

The device's performance is established through substantial equivalence to a predicate device (K211709) and compliance with relevant safety and performance standards for ECG recording devices.

Below is information that can be extracted or inferred from the document, with explanations for why certain requested fields cannot be filled:

1. A table of acceptance criteria and the reported device performance

   Given that this device is a recorder and not an analytical AI tool, there are no acceptance criteria for algorithmic performance (e.g., sensitivity, specificity, AUC for disease detection). The "performance" as described is its ability to record ECG data and meet general safety and essential performance standards.

   Acceptance Criteria (Inferred for a Recorder)	Reported Device Performance (Summary)
   Basic Safety and Essential Performance	Device passed IEC 60601-2-47:2012
   Ability to record 3-lead ECG data	Records 3-lead ECG, continuous
   Recording duration	Up to 30 days
   Defibrillator Protection	Not Defibrillator Proof (IEC 60601-1 passed)
   Data Transfer	Via Bluetooth to Biotres Gateway App, then to Secure Server
   Charging	Via dedicated AC wall charger; USB for charging
   Physical form factor	Small, lightweight, body-worn ambulatory cardiac monitor
   Interface	Power button, patient event marking button, LED indicator

2. Sample sizes used for the test set and the data provenance

   Not applicable in the context of AI/ML performance testing for this device. The document mentions general "performance and safety tests" (IEC 60601-2-47:2012) but does not detail a "test set" in the sense of a dataset for algorithmic validation. Device testing for hardware and basic functionality typically uses a limited number of physical units, not large patient datasets for performance metrics.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

   Not applicable. Ground truth for algorithmic performance is not established because the device does not perform automated analysis. The interpretation of the ECG data recorded by Biotres is explicitly left to "qualified medical personnel" and "physician or trained healthcare professional."

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   Not applicable, as there is no algorithmic test set requiring ground truth adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

   No. The device does not provide AI assistance for human readers. Its function is data recording.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

   No. The device does not have a standalone algorithm for diagnostic performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

   Not applicable, as there is no algorithmic performance claim that would require ground truth.

8. The sample size for the training set

   Not applicable, as there is no AI algorithm being trained by this device.

9. How the ground truth for the training set was established

   Not applicable, as there is no AI algorithm being trained by this device.

Summary of Device Functionality Relevant to the 510(k) Summary:

The Biotres is a hardware device designed to continuously record 3-channel ECG data from adult patients for up to 30 days. It has buttons for power and patient event marking, an LED status indicator, and connects to mobile devices via Bluetooth for data transfer to a secure server. The recorded ECG data is intended for review and interpretation by qualified medical professionals using separate ECG viewing software (Bioflux Software II). The key point reiterated is that the device "is not intended and should not be used for automated or semi-automated analysis." Its 510(k) clearance is based on substantial equivalence to a previously cleared predicate device (K211709) and compliance with general medical device safety and performance standards.

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The Biotres is indicated for use on adult patients 18 years or older who may be asymptomatic or who suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light headedness, pre-syncope, fatigue, chest pain and/or anxiety and may require cardiac recording on a continuous basis for up to 30 days. The signal acquired by the Biotres is not intended and should not be used for automated or semi-automated analysis.

The Biotres system consists of 1) the Biotres Recorder, 2) a dedicated Biotres AC wall charger, 3) Biotres Gateway application for use on mobile devices using Android or iOS, and 4) Biotres Configured Secure Server.

Biotres Recorder: The Biotres Recorder is an ECG recording only device and does not include ECG analysis, an ECG viewer/EGG display, alarms and is not a real time ECG monitor. The Biotres recorder is a small, lightweight, ambulatory, reusable 3 channel ECG recorder that is placed on the center of the chest.

Biotres AC Wall Charger: The dedicated Biotres AC Wall charger is used to charge the Biotres Recorder daily when disconnected from the patient.

Biotres Gateway Application: The ECG recorded data is transferred via the Biotres Gateway App (Downloaded from the app store for iOS or Android respectively) via a Bluetooth connection and subsequently to the Biotres Configured Secure Server.

Biotres Secure Server: The Biotres Configured Secure Server is an SFTP server that is configured to work with the Biotres System. The server enables the Clinician, through secured login, to command the Biotres Recorder (e.g. initiate ECG data collection) and to access uploaded MIT16 ECG data recordings when the ECG data collection is complete.

This FDA 510(k) submission for the Biotres device does not include the detailed information required to describe acceptance criteria and associated study results for an AI/ML powered device. The Biotres is described as an ECG recording-only device that does not include ECG analysis, an ECG viewer/display, alarms, or real-time ECG monitoring. It explicitly states: "The signal acquired by the Biotres is not intended and should not be used for automated or semi-automated analysis."

Therefore, the following information cannot be extracted from the provided document:

1. A table of acceptance criteria and the reported device performance: Not applicable, as there are no automated analysis functionalities to evaluate.
2. Sample size used for the test set and the data provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The document primarily focuses on regulatory clearances, device description, comparison to a predicate device (ePatch), and performance testing related to electrical safety, electromagnetic compatibility, usability, and biocompatibility, as well as bench tests verifying ECG signal recording and transmission capabilities. These are standard tests for a medical device that records data but does not perform automated analysis.

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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:

• 1. It is a cardiology software product, running locally in a browser.
• 2. Bioflux Software II operates on 2018 or later versions of Chrome and Firefox browsers.
• 3. 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.
• 4. 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

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.

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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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