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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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