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The zensor monitoring device is a small, lightweight, wearable battery operated system connected to an electrode accessory (single-use disposable Intelesens zensor Electrode Array) which in turn is in contact with the patient's body.

The device is to be used in the home environment to provide clinicians with patient physiological data.

The zensor monitoring system provides full disclosure ECG and cardiac event monitoring for adult patients.

The zensor monitoring system displays ECG and respiration waveforms from the reserver. The system monitors the following configurable physiological parameters: Heart Rate, as well as key cardiac arrhythmias, and a patient activated recording.

The zensor monitoring system has the option to store full disclosure ECG. Respiration and accelerometer data and/or wirelessly transmit pre-defined event alerts to the Intelesens zensoronine system for review by healthcare practitioners. All physiological data stored on the device can be imported for viewing on Intelesens zensor+ (Ambulatory Full Disclosure ECG and Event Viewer) for later analysis by a clinician.

The zensor system includes the following components:

• zensor device a wireless (Wi-Fi) monitoring device .
• . Adherent electrode array

Software

• . zensor App for configuration of device settings
• . zensoronline web based monitoring application identical to Canberra cleared in K110015 and K131000 except for name change and support of zensor functionality.
• zensor+, full disclosure and event data viewing PC software .

The zensor also includes a standalone battery charger. Charging does not / cannot occur when the zensor device is connected to a patient.

The zensor device monitors physiological parameters and is a wireless, wearable ECG and respiratory monitor. It is a small, battery-operated system comprised of the zensor monitoring unit (a body worn transmitter device), the zensor electrode array, and zensor battery pack. The zensor device is connected to the electrode array via magnetic studs, and the array is positioned as appropriate on the patient's body. The electrode array consists of three patch electrodes containing conductive gel and is self-adhesive and will adhere to the patient's skin. The zensor device communicates to a remote data base using Wi-Fi or mobile hotspot. The rechargeable battery pack contains a rechargeable 3.7V lithium ion battery to power the zensor device. The battery pack is charged using the zensor single bay charging dock. When fully charged the life of the battery pack can be up to three days (dependent on device configuration).

The physiological parameters monitored include ECG and respiration waveforms, heart rate and respiration rate, activity, detection of cardiac arrhythmias (Asystole, Tachycardia, Ventricular Fibrillation, Bradycardia and Atrial Fibrillation) and recording of patient-activated events.

The zensor monitoring device has the option to store full disclosure ECG and respiration data and/or wirelessly transmit pre-defined event alerts or patient-activated recordings to the Intelesens zensor online system for review by healthcare practitioners. All physiological data stored on the device can be downloaded for viewing on Intelesens zensor+ (Ambulatory Full Disclosure ECG and Event Viewer) for later analysis by a clinician.

The device also contains on-board ECG arrhythmia detection algorithms to automatically record and send ECG data on detection of one or more of the following arrhythmias:

• asystole, ●
• . ventricular fibrillation, (VF)
• bradycardia
• atrial fibrillation (AF) ●
• tachycardia ●

Accelerometer: The zensor device incorporates a digital accelerometer MEMS (Micro Electro Mechanical System). This is used to monitor 3-axis acceleration, providing information on patient activity.

Electrode Array

• The zensor electrode array is a patient worn adhesive sensor that facilitates the ● acquisition of ECG (3 lead) and respiration signals.
• The array is placed onto the patient following the instructions detailed in the user manual.
• . The array consists of three electrodes and 5 magnetic studs for connecting to the device.

zensor electrode array has the same patient contact materials as the V-Patch electrode (K131000)

The provided text describes the "zensor System," which is a wearable ECG and respiratory monitor. It monitors physiological parameters including ECG and respiration waveforms, heart rate and respiration rate, activity, and detects cardiac arrhythmias.

Here's an analysis of the acceptance criteria and study information:

1. Table of acceptance criteria and reported device performance:

The document explicitly states that the device was tested for "Compliance with AAMI EC 57." AAMI EC57:1998/(R) 2008, "Testing and reporting performance results of cardiac rhythm and ST-segment measurement algorithms," sets performance standards for arrhythmia detection. Although the specific numerical acceptance criteria (e.g., sensitivity, specificity thresholds) from AAMI EC57 are not detailed in this submission, the statement of compliance implies that the device met these established standards.

The document lists the following cardiac arrhythmias that the device's algorithms are designed to detect:

• Asystole
• Ventricular Fibrillation (VF)
• Bradycardia
• Atrial Fibrillation (AF)
• Tachycardia

However, the specific reported performance metrics (e.g., sensitivity, specificity, accuracy) for each of these arrhythmia detections are not provided in this summary. The summary only states "Compliance with AAMI EC 57."

2. Sample size used for the test set and the data provenance:

The document mentions "Compliance with AAMI EC 57" for testing arrhythmia detection algorithms. AAMI EC57 typically requires testing on standardized ECG arrhythmia databases (such as MIT-BIH Arrhythmia Database, AHA Database, European ST-T Database, etc.) which are collections of retrospective physiological data. However, the specific size of the test set (number of patients, duration of recordings) and the country of origin of the data are not explicitly stated in this document. It's implied that a retrospective dataset was used given the standard practice for AAMI EC57 testing.

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

AAMI EC57 compliance often involves comparing algorithm output against expert-annotated ground truth. However, the exact number of experts, their qualifications, and the specific method of ground truth establishment for the test set used for this device are not detailed in the provided text.

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

The adjudication method used to establish the ground truth for the test set is not specified in the document. For AAMI EC57 compliance, ground truth is typically established by expert cardiologists reviewing and annotating the ECG data.

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:

The document does not mention an MRMC comparative effectiveness study involving human readers or the effect size of human improvement with AI assistance. The focus of the performance data section is on the device's algorithmic performance and compliance with technical standards.

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

Yes, a standalone performance evaluation was done. The document states that "The zensor System has been tested in accordance with the relevant test plans/reports included with this 510(k) submission using the production equivalent units prior to release to market." It specifically references "Compliance with AAMI EC 57," which is a standard for evaluating the performance of cardiac rhythm and ST-segment measurement algorithms in a standalone capacity.

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

For "Compliance with AAMI EC 57," the ground truth typically involves expert-annotated ECG recordings from established arrhythmia databases. However, the specific method for establishing ground truth is not explicitly stated in this summary.

8. The sample size for the training set:

The sample size used for training the device's algorithms is not specified in this document.

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

The method for establishing ground truth for the training set is not specified in this document.

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The Intelesens V-Patch System is designed to monitor and transmit ECG data to a web based host application for display or analysis by a clinician. The device can be worn by ambulatory or non-ambulatory adult patients in a healthcare or home environment to support clinical staff when they are carrying out their routine observations or when a patient would otherwise be in an unmonitored or unobserved situation.

The re-usable device is intended to be used with a single use electrode on the patient for up to seven days.

The V-Patch System uses an on-board ECG arrhythmia detection algorithm to automatically record and send ECG data if the user is suspected to be experiencing an arrhythmia event. The device transmits the data to the host application at user defined intervals or upon the detection of an arrhythmia event. The V-Patch also has a patient activated button that allows ECG to be recorded and transmitted on-demand should the patient experience any relevant symptoms.

The V-Patch device is a small, lightweight wearable device that is connected to an accessory electrode that is applied to the patient's body. The electrodes are a proprietary Intelesens design. The patient wearable monitor is named the V-Pod operates on user replaceable coin cells. The device wirelessly transmits physiological data relating to ECG and heart rate to a receiving station - the V-Cell via a wireless ANT connection.

The V-Cell interfaces to the Internet via GPRS allowing for web-based analysis by a clinician on the Canberra System. There are also on-board algorithms that continuously monitor for, and record ECG on detection of nine cardiac arrhythmias and a patient activated event button. The cardiac arrhythmias detected are:

• . Bradyarrhythmia
• . Ventricular Tachycardia
• . Supraventricular Tachycardia
• Ventricular Fibrillation .
• . Atrial Flutter
• . Atrial Fibrillation
• l st degree Heart Block .
• . 2nd degree Heart Block
• . 3rd degree Heart Block

The provided text describes the V-Patch System, a physiological patient monitor, and its 510(k) submission. However, it does not contain specific acceptance criteria or a detailed study proving the device meets acceptance criteria beyond general statements of compliance with standards.

The document states:

• "The V-Patch System has been tested in accordance with the relevant test plans/reports included with this 510(k) submission using the production equivalent units prior to release to market."
• It lists tests performed: Hardware Verification, Compliance with IEC 60601-1, Compliance with IEC 60601-1-2, System Validation, Electrode Validation Summary inclusive of AAMI EC12 compliance, Compliance with AAMI EC 57, Electrode Storage test, and AAMI ANSI EC38.
• "The V-Patch has equivalent specifications of performance as the predicate."

Without access to the "relevant test plans/reports" mentioned, specific numerical acceptance criteria and reported device performance are not available in this summary.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as this information is not present in the provided 510(k) summary.

Based on the provided text, I can extract the following information, but many requested details are missing:

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

   • Information Missing: The document states the device was tested for compliance with various standards (IEC 60601-1, IEC 60601-1-2, AAMI EC12, AAMI EC57, AAMI ANSI EC38) and underwent Hardware Verification, System Validation, and Electrode Storage tests. However, the specific numerical acceptance criteria for these tests and the reported device performance against those criteria are not detailed in this summary. It only states "Compliance with AAMI EC 57" for example, not the specific metrics within EC 57 that were met and by what margin.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Information Missing: The document does not specify the sample size used for any test sets or the provenance of the data (e.g., country of origin, retrospective/prospective nature).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • Information Missing: The document makes no mention of experts or the establishment of ground truth for specific test sets. The device has "on-board algorithms that continuously monitor for, and record ECG on detection of nine cardiac arrhythmias," implying an automated detection process, but no human expert review process for evaluation is described in the provided summary.

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

   • Information Missing: No adjudication method is described, as there's no mention of human expert review.

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:

   • Information Missing: No MRMC study is mentioned. The device's purpose is to "monitor and transmit ECG data to a web based host application for display or analysis by a clinician" and to "automatically record and send ECG data if the user is suspected to be experiencing an arrhythmia event." This implies a potential assistance role, but no study on the effectiveness of human readers with vs. without AI assistance is described.

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

   • Partial Information: The document states, "The V-Patch System uses an on-board ECG arrhythmia detection algorithm to automatically record and send ECG data if the user is suspected to be experiencing an arrhythmia event." This confirms the existence of a standalone algorithm for arrhythmia detection. The "Compliance with AAMI EC 57" suggests evaluation of rhythm and ST-segment measurement algorithms, which would typically involve standalone performance assessment. However, specific performance metrics for this standalone algorithm are not listed.

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

   • Information Missing: The specific type of ground truth used for evaluating the arrhythmia detection algorithm is not stated. AAMI EC57 involves established arrhythmia databases and methods for performance evaluation against known truth, but the details of how that truth was established for the specific data used by Intelesens are not in this summary.

8. The sample size for the training set:

   • Information Missing: No information about a training set or its sample size is provided.

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

   • Information Missing: As no training set information is provided, how its ground truth was established is also not mentioned.

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The Intelesens Vital Signs Monitor Aingeal (VS200) is used to monitor and transmit physiological data to a web based host application for display or analysis by a clinician. The device can be worn by ambulatory or non-ambulatory adult patients in a healthcare environment to support clinical staff when they are carrying out their routine observations or when a patient would otherwise be in an unmonitored or unobserved situation.

This re-usable device is intended to be used on the patient for short term periods only.

The device is intended to be used on adult patients for monitoring of ECG, respiration, heart rate, skin temperature and activity levels in a healthcare setting.

The device can be used where information on ECG, respiration, heart rate, skin temperature, and activity levels would be useful.

The device uses on-board ECG arrhythmia detection algorithms to automatically record and send ECG data if the user is suspected to be experiencing an arrhythmia event. The device transmits the data to the host application at user defined intervals or upon the detection of an arrhythmia event.

The Aingeal (VS200) is a small, lightweight wearable device that is connected to an accessory electrode that is applied to the patient's body. The device wirelessly transmits physiological data relating to ECG, heart rate, respiration, skin temperature and motion to a receiving station via a WiFi connection for display or for analysis by a clinician. The device alerts clinicians when a patient's heart rate changes outside of pre-defined that can be modified by clinical staff. There are also on-board algorithms that continuously monitor for, and record ECG on detection of seven cardiac arrhythmias.

This document does not contain sufficient information to fulfill the request. The text mentions that "The Intelesens Aingeal (VS200) was tested in accordance with the relevant test plans/reports included with this 510(k) submission," but it does not provide any specifics about these test plans, reports, or the performance data itself. Therefore, I cannot extract the acceptance criteria or reported device performance, nor can I determine details about sample sizes, ground truth establishment, or study methodologies.

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