(20 days)
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:
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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 -
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.
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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."
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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.
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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.
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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.
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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.
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The sample size for the training set
Not applicable, as there is no AI algorithm being trained by this device.
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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.
§ 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).