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The AVIVO™ Mobile Patient Management (MPM) System is intended to continuously measure, record and periodically transmit physiological data. The AVIVOTM MPM System is indicated for patients:

• · With fluid management problems
• · Taking diuretic medication
• · Living with heart failure
• · Living with end-stage renal disease
• Suffering from recurrent dehydration
• Who require monitoring for the detection of non-lethal cardiac arrhythmias such as, but not limited to, supraventricular tachycardias (e.g. atrial florillation, atrial flutter, paroxysmal SVTs), ventricular ectopy, bradyarthythmias and conduction disorders.

The AVIVO™ MPM System monitors, derives and displays:

• · ECG
• · Heart Rate (including HR variability)
• · Activity
• Posture
• · Respiration Rate (including RR variability)
• · Body Fluid Status

The system has not been tested specifically for pediatric use.

The AVIVO™ MPM System is a wearable, wireless physiological monitoring and arrhythmia detection system that is used by patients to aid clinicians in the identification, diagnosis and management of various clinical conditions, events and/or trends. It consists primarily of the Wearable Sensor (monitoring device) and the Transmitter (portable data transmission device). In combination with interpretation services provided by Medtronic Monitoring, Inc.'s Monitoring Center, as well as secure online review of data by healthcare providers, the AVIVO™ MPM System enables patient- and physician-friendly physiological monitoring and arrhythmia detection for extended periods of time.

The AVIVO™ MPM System is comprised of the following non-sterile components:

• The Wearable Sensor, which adheres to the patient's torso, contains electrodes and ● sensors for recording patient information.
• . The Transmitter, which is the patient hand-held transceiver, receives information from the Wearable Sensor and transmits it to the Medtronic Server.
• . The secure Server, which receives information from the Wearable Sensor via the Transmitter, and among other things, derives, calculates and displays the patient's physiological parameters using the data collected by the Wearable Sensor.

This 510(k) summary explicitly states that it is a "Special 510(k): Device Modification." This means the submission is for a modification to an already cleared device (the predicate AVIVO™ MPM cleared in K113187). Therefore, the provided document does not contain new, comprehensive clinical study details with acceptance criteria and performance data for the entire device as if it were a de novo submission. Instead, the focus is on demonstrating that the modifications made do not raise new questions of safety or effectiveness and that the device remains substantially equivalent to its predicate.

As such, many of the requested details about specific acceptance criteria and a single, overarching study proving performance are not directly available in this document. The document refers to "testing for this change already provided in K133701" or "N/A – no clinical testing required for this modification," indicating that the performance data for the core functions were established in previous submissions.

However, I can extract information related to the demonstration of substantial equivalence for the modifications described:

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

The document does not present a single table detailing acceptance criteria for specific performance metrics of the device itself (e.g., arrhythmia detection sensitivity/specificity) and corresponding reported performance from a new study. Instead, it summarises the types of testing done or referenced for the modifications and states their successful completion to demonstrate substantial equivalence.

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

The document explicitly states "N/A – no clinical testing required for this modification" for all modifications described. Therefore, no new clinical test set with specific sample sizes or data provenance (country, retrospective/prospective) is detailed in this submission for the modified device. The original clearance (K113187) would contain such details for the predicate device.

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):

As no new clinical testing was reported as required for these modifications, this information is not available in the provided document.

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

As no new clinical testing was reported as required for these modifications, this information is not available in the provided document.

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 AVIVO™ MPM System is described as a "wearable, wireless physiological monitoring and arrhythmia detection system" and focuses on collecting and transmitting data for clinicians to review. It does not appear to be an AI-assisted diagnostic tool that aids human readers in interpreting images or complex signals, as would typically be the subject of a MRMC study. No MRMC study is mentioned.

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

The device's core function is to "continuously measure, record and periodically transmit physiological data" and to "derive, calculate and display the patient's physiological parameters." The "arrhythmia detection" is an algorithmic output. The document references "AAMI/ANSI EC 57: Testing and reporting performance results of cardiac rhythm and ST-segment measurement algorithms." This standard typically outlines methodologies for validating the performance of such algorithms in a standalone manner. While a specific study report isn't included here, the adherence to this standard for the predicate device implies standalone algorithmic testing was conducted and proven.

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

For arrhythmia detection, the AAMI/ANSI EC 57 standard generally requires comparing algorithmic detections against human expert review (e.g., experienced cardiologists or electrophysiologists) of the ECG traces, often with adjudicated consensus to establish ground truth. For other physiological parameters like heart rate, respiration rate, and activity, ground truth would typically be established by simultaneously recorded gold-standard measurement devices. The document does not provide specifics for this submission as it refers to previous clearances.

8. The sample size for the training set:

The document does not detail any new training sets or their sample sizes for the modifications described, as it focuses on demonstrating substantial equivalence to a previously cleared device. Information on the training set for the original arrhythmia detection algorithms would be in the predicate device's 510(k) submission.

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

Similar to point 8, this information is not provided in this specific 510(k) summary as it pertains to modifications rather than a de novo clearance. For the predicate device's algorithms, ground truth for training data would typically be established by expert annotation of physiological data (e.g., ECGs) for arrhythmias, or concurrent measurements from gold-standard devices for other parameters.

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The AVIVO Mobile Patient Management System is intended to continuously record, store, and periodically transmit physiological data. The System is indicated for patients:

• with fluid management problems .
• taking diuretic medication .
• living with heart failure .
• living with end-stage renal disease .
• suffering from recurrent dehydration .
• who require monitoring for the detection of non-lethal cardiac arrhythmias such as, but . not limited to, supraventricular tachycardias (e.g. atrial fibrillation, atrial flutter, paroxysmal SVTs), ventricular ectopy, bradyarrhythmias and conduction disorders.

The AVIVO Mobile Patient Management System also monitors, derives and displays:

• ECG .
• Heart Rate (including HR variability) .
• . Activity
• . Posture
• Respiration rate (including RR variability)
• Body fluid status

The AVIVO System is wearable, wireless arrhythmia detection system that is used by clinicians to identify suspected cardiac arrhythmias and monitor physiologic signals. In combination with interpretation services provided by learned intermediaries in the Corventis Monitoring Center as well as online review of data (for prescribing physicians only), AVIVO enables arrhythmia detection and other physiological data monitoring for up to 7 days for each PiiX application.

The AVIVO system components are:

• . PiiX® (aka: Adherent Device) - a patient-worn device which is applied to the patient's torso. It contains the ECG electrodes for recording ECG, heart rate and other physiological data.
• . zLink® (aka: Gateway) – hand-held device that receives information from the PiiX and transmits it to the Corventis Server via cellular technology.
• Server The Server receives sensor data from the PiiX via zLink. ECG, heart . rate and other physiological parameters are presented to learned intermediaries, Corventis cardiographic technicians, who prepare and deliver the information to prescribing physicians

The communication between the PiiX and the zLink is enabled via BlueTooth Technology. Sensor data and ECGs collected by the PiiX are transmitted to the Server via zLink.

This submission is for an abbreviated 510(k) for the AVIVO® Mobile Patient Management System. The purpose of this submission is to add clarifying language to the indications for use, aligning it with language used in a predicate device (NUVANT) for non-lethal arrhythmias and with another predicate device (ZOE) for fluid status measurements. The manufacturer states that these changes are for clarification and do not alter the intended use, safety, or effectiveness of the device. Consequently, the performance testing details provided focus on compliance with recognized medical device standards rather than a study demonstrating new device performance against acceptance criteria for specific clinical outcomes or algorithm accuracy.

Here's an analysis of the provided text based on your request:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not present specific acceptance criteria in terms of clinical performance metrics (e.g., sensitivity, specificity for arrhythmia detection or fluid status accuracy) and corresponding reported performance from a dedicated clinical study for the subject device. Instead, it relies on demonstrating substantial equivalence to predicate devices and adherence to established performance standards for medical electrical equipment.

2. Sample Size Used for the Test Set and Data Provenance:

The document mentions "bench tests" (Section 4, "SUMMARY OF PERFORMACE TESTING" and Section 4, "CONCLUSION") but does not provide details on sample sizes for any test sets related to specific clinical performance. The focus is on meeting general safety and performance standards for existing medical devices, rather than a clinical study with a patient test set for the device's diagnostic or monitoring accuracy. Therefore, information on data provenance (country of origin, retrospective/prospective) is not provided.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable. No clinical test set and associated ground truth establishment process are described for the subject device in this submission, as the submission relies on substantial equivalence and adherence to general performance standards mentioned in Section 4.

4. Adjudication Method for the Test Set:

Not applicable. No test set requiring expert adjudication is described in this submission.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. The document does not describe an MRMC study comparing human readers with and without AI assistance, nor does it provide an effect size for human reader improvement. The device described transmits physiological data to "learned intermediaries, Corventis cardiographic technicians, who prepare and deliver the information to prescribing physicians." This implies human interpretation as part of the overall system, but not a comparative effectiveness study of AI assistance.

6. Standalone (Algorithm Only) Performance:

Not explicitly detailed as a separate study for the subject device. The device is part of a system that includes human interpretation ("learned intermediaries"). While the device's algorithms for parameters like heart rate and respiration rate would operate in a standalone manner within the device, a dedicated "standalone performance" study comparing its algorithmic output to a ground truth (independent of human interpretation) is not presented in this document as a part of the evidence for this 510(k) submission. The performance is tied to the overall system's ability to "continuously record, store, and periodically transmit physiological data" and meet general device standards.

7. Type of Ground Truth Used:

For the performance testing mentioned (compliance with standards), the ground truth would be the defined specifications and measurement methodologies within those standards (e.g., standard signal inputs for ECG accuracy tests as per AAMI/ANSI EC38/EC57). There is no mention of a clinical ground truth (e.g., pathology, outcomes data, or expert consensus from patient data) specifically generated for this 510(k) submission.

8. Sample Size for the Training Set:

Not applicable. The document does not describe the development or training of a specific artificial intelligence or machine learning algorithm that would require a dedicated training set. The device is being submitted as an updated version of an existing device (predicate AVIVO), with clarifications to its indications for use, and its performance relies on established engineering principles and adherence to recognized standards.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as no training set for an AI/ML algorithm is described.

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The AVIVO™ Mobile Patient Management System is intended to continuously record, store, and periodically transmit physiological data. The System is indicated for those patients who require monitoring for the detection of non-lethal cardiac arrhythmias. The AVIVO Mobile Patient Management System also monitors, derives and displays:

• ECG
• Heart Rate (including HR variability)
• Activity
• Posture
• Body Temperature
• Respiration rate (including RR variability)
• Body fluid status

The NUVANT™ Mobile Cardiac Telemetry (MCT) System is intended to continuously measure, record, and periodically transmit physiological data. The System is indicated for those patients who require monitoring for the detection of non-lethal cardiac arrhythmias. The NUVANT system model monitors, derives and displays:

• ECG
• Heart rate

The Systems may also monitor, derive and display:

• Activity
• Posture
• Body temperature
• Respiration rate (including RR Variability)
• Body fluid status
• Heart rate variability

The NUVANT is essentially the AVIVO with the addition of a patient trigger magnet. The following are the system components of both models:

• PiiX™ (aka Adherent Device)
• Patient Trigger Magnet (specific to NUVANT)
• zLink™ (aka Gateway)
• Server

The PiiX is a patient-worn device which is applied to the patient's torso. It contains the ECG electrodes for recording ECG and heart rate data; the impedance sensor for collecting respiration and body fluid data; the accelerometer for collecting activity and posture. Additionally, resided in the PiiX is a heart rate, timing and morphology based arrthythmia detection algorithm which allows the system to discriminate waveforms based on morphology and also count ectopic beats (such as PVCs and PACs) and calculate atrial fibrillation burden of the patient.

Specfic to the NUVANT is the Magnet, which is part of the Patient Trieger feature. This external piece accompanying the PiiX and is used by the patient to manually trigger the ECG collection when he/she experiences symptoms. Patient triggers the ECG collection by swiping the Magnet across the PiiX. The ECG waveform will then be transmitted to the Server via zLink.

zLink receives information from the PiiX and transmits them to the Corventis Server. It also interacts with the Corventis Server to receive configuration updates and other relevant hardware diagnostic information.

The Server receives sensor data from the PiiX via zLink. Data from the accelerometer is derived into activity and posture; data from the impedance sensor is derived into respiration rate, respiration variability and body fluid status. ECG and heart rate are presented without derivation.

Additionally, the secure server performs the following functions:

• Display the physiological parameters in trend graphs format.
• Display ECG waveform that corresponds to a detected arrhythmia
• Provide patient's Afib burden, if applicable
• Provide visual notifications for the detected arrhythmia.
• Provide the users the ability to acknowledge or dismiss events.

The communication between the PiiX and the zLink is enabled via the BlueTooth™ Technology. The zLink transmits the data to the Server via cellular technology, where healthcare professionals can access with standard browsers.

This document describes a Special 510(k) submission for modifications to the AVIVO™ Mobile Patient Management System and NUVANT™ Mobile Cardiac Telemetry System. The primary modification involves an enhanced arrhythmia detection algorithm that incorporates morphology and timing of waveforms, in addition to heart rate, to discriminate waveforms, count ectopic beats (PVCs, PACs), and calculate atrial fibrillation (Afib) burden.

Unfortunately, the provided text does not contain a dedicated section detailing acceptance criteria or specific study results that prove the device meets these criteria. It asserts that the devices are "as safe and as effective as the predicate devices" based on "descriptive information and the design verification tests," but does not present the data from these tests.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I provide information regarding sample sizes, ground truth establishment, expert qualifications, or MRMC studies, as this information is not present in the provided text.

Based on the available information, here's what can be inferred:

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

• Acceptance Criteria: Not explicitly stated in the document. The document implies the acceptance criteria were met by demonstrating substantial equivalence to predicate devices, particularly in the modified arrhythmia detection algorithm.
• Reported Device Performance:
  • The modified algorithm allows the devices to:
    • Discriminate waveforms based on morphology.
    • Count ectopic beats (PVCs and PACs).
    • Calculate atrial fibrillation burden.
  • The intent of the subject devices remains the same as the predicate devices: to monitor ECG and other vital parameters.
  • No change has been made to the Indication for Use Statements, implying performance is at least equivalent to the predicate performance for those indications.

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

• This information is not provided in the document.

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):

• This information is not provided in the document.

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

• This information is not provided in the document.

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:

• An MRMC study is not mentioned in the document. The submission focuses on the algorithm's performance and equivalence to predicate devices, not on human-AI collaboration.

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

• Yes, implicitly. The document describes modifications to an "arrhythmia detection algorithm" (page 3) and refers to demonstrating substantial equivalence based on "descriptive information and the design verification tests" (page 5). While direct performance metrics for the algorithm are not provided, the claim of "discriminating waveforms based on morphology and also count ectopic beats (such as PVCs and PACs) and calculate atrial fibrillation burden" implies internal testing of the algorithm itself.

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

• This information is not provided in the document. Given the context of arrhythmia detection, it is highly likely that cardiologist review or a validated ECG database would be used, but this is not explicitly stated.

8. The sample size for the training set:

• This information is not provided in the document.

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

• This information is not provided in the document.

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The AVIVO™ Mobile Patient Management System is intended to continuously record, store, and periodically transmit physiological data. The System is indicated for those patients who require monitoring for the detection of non-lethal cardiac arrhythmias. The AVIVO™ Mobile Patient Management System also monitors, derives and displays:
• ECG

• · Heart Rate (including Heart Rate Variability)
• · Activity
• Posture
• · Body Temperature
• · Respiration rate (including Respiratory Rate Variability)
• Body fluid status

The AVIVIO Mobile Patient Management System includes the following components:

• Adherent Device .
• Gateway .
• Server .
  The Adherent Device is a patient-worn device. It collects, stores and transmits user physiological parameters. The Adherent Device, when applied to the user's torso, will automatically activate and measure the above mentioned physiological parameters. Data collected by the sensors are transmitted to the Server for derivation and display via the Gateway periodically. ECG signals recorded by the Adherent Device will be transmitted on a heart rate trigger basis with predetermined thresholds that are not user adjustable. The ECG signals are also transmitted periodically and will be displayed via the Server.
  The Gateway receives information from the Adherent Device and transmits them to the Corventis Server. It also interacts with the Corventis Server to receive configuration updates and other relevant hardware diagnostic information.
  The Server receives information from the Adherent Device via the Gateway. The secure server performs the following functions:
• Derive physiological parameters using the raw data collected by the Adherent . Device.
• Display the physiological parameters in trend graphs format. .
• Display ECG waveform when the heart rates are beyond the specified threshold. t
• Provide visual notifications when healthcare professionals need to be aware of . heart rates that are beyond the specified threshold.
• Provide patient summary reports. .
  The communication between the Adherent Device and the Gateway is enabled via the BlueTooth™ Technology. The Gateway transmits the data to the Server via cellular technology, where healthcare professionals can access with standard browsers.

The provided text from K083287 does not contain any information regarding acceptance criteria, device performance metrics, or details of a study proving the device meets acceptance criteria.

The document is a 510(k) Summary of Safety & Effectiveness, which primarily focuses on establishing substantial equivalence to predicate devices based on intended use and technological characteristics. It lists the components of the AVIVO Mobile Patient Management System and its functions, and identifies predicate devices for various aspects of the system.

The "Conclusions" section briefly states: "Performance testing conducted on the AVIVO Patient Management System demonstrates that the product performs as it is intended to." However, no specifics about this performance testing (e.g., methodology, results, acceptance criteria, sample sizes, ground truth) are provided.

Therefore, I cannot extract the requested information.

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