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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 such as, but not limited to, supraventricular tachycardias (e.g. atrial fibrillation, atrial flutter, paroxysmal SVTs), ventricular ectopy, bradyarrhythmias and conduction disorders.

The NUVANT MCT System is wearable, wireless arrhythmia detection system that is used by clinicians to identify suspected cardiac arrhythmias. 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), NUVANT MCT enables arrhythmia detection for up to 7.5 days for each PiiX application.

The NUVANT 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 and heart rate data.
• Patient Trigger Magnet used by the patient to manually trigger the ECG collection when he/she experiences symptoms.
• 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 and heart rate 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.

The provided text describes an Abbreviated 510(k) submission for the NUVANT Mobile Cardiac Telemetry (MCT) System, focusing on adding clarifying language to its indications for use. It asserts that this clarification does not alter the fundamental safety and effectiveness of the device compared to its predicates. However, the document does not contain explicit acceptance criteria or a detailed study proving the device meets specific performance criteria.

The document refers to the device meeting general performance standards, but it does not provide the specific data from a study to demonstrate this.

Therefore, I cannot fulfill all parts of your request with the provided information. I can, however, extract related details:

Missing Information:

• A table of acceptance criteria and the reported device performance.
• Sample size used for the test set.
• Data provenance for the test set (country of origin, retrospective/prospective).
• Number of experts used to establish ground truth for the test set and their qualifications.
• Adjudication method for the test set.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human reader improvement with AI vs. without AI.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for the test set.
• The sample size for the training set.
• How the ground truth for the training set was established.

Information that can be extracted or inferred:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not specified.
• Data Provenance: Not specified. The document only mentions "bench tests" for supporting the claim of safety and effectiveness.

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

• Not specified. The document mentions "learned intermediaries in the Corventis Monitoring Center as well as online review of data (for prescribing physicians only)" for real-world operation, but this is not tied to establishing ground truth for a test set in the context of the device's validation for this submission.

4. Adjudication method for the test set:

• Not specified.

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:

• Not specified. The NUVANT system involves human interpretation (Corventis cardiographic technicians and prescribing physicians), but the document does not describe an MRMC study or quantify human improvement with AI assistance. The system itself is characterized as an "arrhythmia detection system" that, in combination with human interpretation services, enables arrhythmia detection.

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

• The document implies the algorithm performs "arrhythmia detection" and transmits data. However, the statement "In combination with interpretation services provided by learned intermediaries in the Corventis Monitoring Center as well as online review of data... NUVANT MCT enables arrhythmia detection" suggests that the full "arrhythmia detection" capability for clinical use involves a human-in-the-loop. A standalone performance study of only the algorithm is not explicitly described with metrics.

7. The type of ground truth used:

• Not specified. The document refers to meeting performance standards and "bench tests" without detailing how ground truth data for these tests were derived.

8. The sample size for the training set:

• Not specified. The document does not mention an "AI" or machine learning component in a way that suggests a distinct training set. It focuses on the device hardware and its embedded detection capabilities.

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

• Not specified, as a training set is not explicitly mentioned.

Summary of what the document DOES state regarding "proving" criteria:

The document relies on the following to demonstrate the device's safety and effectiveness:

• Substantial Equivalence: The primary assertion is that the "subject NUVANT" is "as safe and as effective as the predicate devices" (NUVANT K091971 and CardioNet CN1005). This is a foundational premise of 510(k) submissions.
• Conformance to Industry Standards: The device meets the requirements of:
  • IEC 60601-1 (General Safety)
  • IEC 60601-1-2 (Electromagnetic Compatibility)
  • AAMI/ANSI EC38 (Ambulatory Electrocardiographic Systems)
  • AAMI/ANSI EC57 (Cardiac Rhythm and ST-segment Measurement Algorithms)
• Bench Tests: The document states that the conclusion of safety and effectiveness is "As supported by the descriptive information and the bench tests". However, no details about these bench tests or their results are provided.
• Minor Change: The core argument for this specific 510(k) is that the proposed change (clarifying language in the indications for use) does not alter the fundamental scientific technology, intended use, safety, or effectiveness of the device.

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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 NUVANT" Cardiac Event Monitor (CEM) System and the NUVANT "Mobile Cardiac Telemetry (MCT) System are intended to continuously measure, record, and periodically transmit physiological data. The Systems are indicated for those patients who require monitoring for the detection of non-lethal cardiac arrhythmias. Both NUVANT system models monitor, derive and display:

• ECG
• Heart rate

The Systems may also monitor, derive and display:

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

The NUVANT™ Cardiac Event Monitor System and the NUVANT™ Mobile Cardiac Telemetry System include the following components:

• PiiX™ (a patient worn adherent device) with Magnet
• zLink
• Server

The PiiX is a patient-worn device which is applied to the patient's torso. The Adherent Device monitors the patient's ECG in a looping mode. There are three circumstances under which the ECG data will be recorded: (i) when the device is first applied and activated, a baseline ECG is collected, (ii) when the detection algorithms residing in the Adherent Device trigger the collection, or (iii) when the patient activates the collection using the magnet. When the ECG collection is triggered, a total of 45 seconds of ECG signals will be collected, with 15 seconds of pre-event and 30 seconds post-event. Same as the AVIVO™ Mobile Patient Management System (predicate device), the PiiX has additional sensors which monitor other physiological parameters described in the Indications for Use Statement. The collected ECG signals and the other sensor data will be transmitted to the Server via the zLink.

The 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 of the CEM/MCT receives information from the PiiX via zLink. 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.
• Provide visual notifications when healthcare professionals need to be aware of heart rates that are beyond the specified threshold.
• Provide the users the ability to select CEM vs. MCT prescription.
• 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 the NUVANT™ Cardiac Event Monitor (CEM) System and the NUVANT™ Mobile Cardiac Telemetry (MCT) System, but it is a regulatory filing (510(k) summary) focused on demonstrating substantial equivalence to predicate devices, not on presenting a standalone study with detailed acceptance criteria and performance data.

Therefore, much of the requested information regarding specific acceptance criteria, study details, and performance metrics is not explicitly present in the provided text. The document primarily focuses on comparing the new device's intended use and technological characteristics to established predicate devices to argue for substantial equivalence.

Here's an attempt to answer based on the available information, with specific notes on what is not found:

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

This information is not provided in the document. The filing states that the NUVANT systems "have the same intended use, similar operating principles and technological characteristics as their predicate devices" and that "design verification tests" were conducted, but it does not specify the acceptance criteria for these tests or report their numerical performance.

2. Sample size 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. The document makes no mention of a clinical test set, its sample size, or data provenance.

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. As no clinical test set is described, there's no mention of experts establishing ground truth for such a set.

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

This information is not provided. Again, no clinical test set is described.

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

This information is not provided. The document describes a device for continuously measuring, recording, and transmitting physiological data for cardiac arrhythmia detection. It does not mention any AI component in the context of improving human reader performance, nor does it detail a comparative effectiveness study involving human readers.

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

The document mentions that the PiiX device has "detection algorithms residing in the Adherent Device" which trigger data collection. While this implies an algorithm operating in a standalone fashion to detect events, the document does not provide any performance metrics for these algorithms in a standalone study. The primary focus is on the device's overall functionality and equivalence to predicate devices.

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

This information is not provided. Given the absence of detailed study results, the method for establishing ground truth for any internal validation is not described.

8. The sample size for the training set

This information is not provided. There is no mention of a training set or its size in the document.

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

This information is not provided. No training set is described.

Summary of what's largely missing:

The provided document is a 510(k) summary, which aims to demonstrate that a new device is "substantially equivalent" to legally marketed predicate devices. This typically involves showing similar indications for use, technological characteristics, and safety and effectiveness, often through engineering and performance testing that is compared to the predicate device's known characteristics, rather than extensive, detailed clinical trials with specific acceptance criteria and performance reporting as might be found in a primary clinical study publication.

The "Conclusions" section states: "As supported by the descriptive information and the design verification tests, it is concluded that the NUVANT™ Cardiac Event Monitor (CEM) System and the NUVANT™ Mobile Cardiac Telemetry (MCT) System are as safe and effective as the predicate devices." This implies that the 'design verification tests' served as the basis for proving equivalence, but the specifics of these tests are not publicly detailed in this document.

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