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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 Aerotel MPM SYSTEM is indicated when patients use with home patient monitoring devices (blood pressure, digital scale, blood glucose level, respiratory peak flow, pulse oximetry) and wish to send the measured data to a central station via modem by telephone, where reports can be generated for the physician and reports can be received over the Internet by physicians and patients.

The system comprises a modem-like device that connects to various cleared measurement devices and a central station program that keeps the records of the patients, and makes the reports available ... the internet.

The Aerotel Medical Systems (1998) Ltd. MPM System functions as a device simplifying the transmission of patient health data from home monitoring devices to a central station for review by physicians and patients.

Here's an analysis of the provided text in relation to acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state specific acceptance criteria in terms of numerical performance metrics (e.g., sensitivity, specificity, accuracy, error rates for data transmission). Instead, the acceptance is based on the system's ability to satisfactorily pass internal tests and its equivalence to predicate devices.

2. Sample Size for Test Set and Data Provenance

• Sample Size for Test Set: Not mentioned. The document states, "The system has been tested with all of the compatible measuring units," but doesn't specify how many tests were run, the number of data points, or the number of patients/users involved in these "non-clinical tests."
• Data Provenance: The tests are described as "Non-clinical tests," implying laboratory or internal testing rather than real-world patient data. There is no information regarding the country of origin of this data, but given the company's location in Israel and the regulatory submission to the FDA in the US, it's likely conducted internally without external patient data. The study is retrospective in the sense that completed tests were reviewed for the submission.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not mentioned.
• Qualifications of Experts: Not mentioned. The "satisfactorily passed the tests" statement implies internal review by the company's technical personnel, but no specifics are provided.

4. Adjudication Method for Test Set

• Adjudication Method: Not mentioned. The nature of the non-clinical tests suggests internal validation against pre-defined functional specifications rather than an external human adjudication process.

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

• MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission explicitly states, "Clinical tests are not necessary because the device does not use new technology." The device's primary function is data transmission, not diagnostic interpretation by human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable to this device's intended use according to the submission.

6. Standalone (Algorithm Only) Performance

• Standalone Performance: Yes, the described "Non-clinical tests" and "software... extensively validated" can be considered a form of standalone performance evaluation for the system's data transmission and processing functions. The device is intended to operate automatically in transmitting data. However, specific metrics (e.g., data transmission error rates, uptime) are not provided, only the general statement that it "satisfactorily passed the tests."

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth for the non-clinical tests would likely be functional specifications and expected data output. For example, if a blood pressure reading of "120/80" was input from a compatible device, the ground truth would be that the system should accurately transmit and present "120/80" at the central station without corruption or error. There would be no "expert consensus," "pathology," or "outcomes data" in the traditional medical sense, as this device's role is data conduit.

8. Sample Size for Training Set

• Sample Size for Training Set: Not applicable. The MPM System, as described, is a data transmission system and not an AI/machine learning device that 'learns' from a training set of data to make predictions or classifications. Therefore, the concept of a "training set" in the context of AI development is not relevant here.

9. How Ground Truth for Training Set Was Established

• How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for an AI/machine learning model.

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