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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 System monitors, derives and displays:

• ECG
• Heart Rate

The NUVANT MCT System consists primarily of the PiX monitoring device and the zLink data transmission device. Once activated, the wearable PiX sensor continuously monitors the heart and automatically collects ECGs. When rhythm abnormalities are detected, data are automatically transmitted from the PiiX device to the zLink, which then automatically transmits the data to the Corventis Monitoring Center. Patients can also trigger transmission of ECGs when they experience cardiac symptoms by using the Patient Trigger Button. Certified cardiographic technicians at the Corventis Monitoring Center review received data and document symptoms reported by patients. Clinical reports, prepared by the Corventis Monitoring Center, are delivered and made available at www.corventis.com to provide data to prescribing physicians for the diagnosis and identification of various clinical conditions, events and/or trends.

The provided document is a 510(k) summary for the NUVANT MCT System (K133701). This submission is for a special 510(k) due to device modifications, where the new device is compared to a previously cleared predicate device (NUVANT Mobile Cardiac Telemetry System, K113372). Therefore, the acceptance criteria and study information provided mainly focus on demonstrating that the modified device performs as well as the predicate device.

Here's a breakdown of the requested information based on the document:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state a table of "acceptance criteria" with numerical performance metrics for the modified device in comparison to the predicate. Instead, it strongly emphasizes that the modified device operates identically to the predicate device in terms of fundamental scientific technology and intended use. The testing performed aimed to demonstrate that the changes did not negatively impact safety or effectiveness and that the system performs "as well as or better than the predicate device."

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 does not specify the sample size used for clinical test sets or the provenance (country of origin, retrospective/prospective) of any clinical data. The submission focuses on verification and validation testing of the device modifications, not a new clinical study. The changes described (increased memory, two-part PiiX, button instead of magnet) are primarily hardware and software modifications.

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. Given that this is a 510(k) for device modifications and not a new clinical trial, it's unlikely that external experts were used in this specific context to establish ground truth for a test set of clinical arrhythmias. The "certified cardiographic technicians at the Corventis Monitoring Center" are mentioned as reviewing data from the deployed system, but this relates to the operational use of the device, not the ground truth establishment for the pre-market testing of the modifications themselves.

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

The document does not describe any adjudication method for a test set. This type of detail is typically associated with clinical studies involving human interpretation of data, which is not the primary focus of this submission for device modifications.

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

No MRMC comparative effectiveness study was done or reported. The device is an "Arrhythmia detector and alarm," and its algorithms automatically detect and transmit ECGs. While algorithms are a core part of its function, the document does not mention any "AI assistance" provided to human readers, nor does it quantify any improvement in human reader performance. This submission focuses on validating the hardware and software changes, ensuring the device's automatic detection capabilities remain equivalent to the predicate.

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

Yes, a form of standalone performance assessment was implicitly done. The "proprietary algorithms based on rate, rhythm and morphology to continuously analyze rhythm abnormalities and to initiate automatic ECG transmission to the Server" are central to the device's function. The "Firmware Verification Testing" and "Software Verification Testing" likely assessed these algorithms' performance in a standalone context to ensure they continued to function correctly after the modifications. However, specific performance metrics (e.g., sensitivity, specificity for arrhythmia detection) of these algorithms are not detailed in this summary. The document states that the "subject NUVANT MCT system uses the same sensors, in the same scientific methods (algorithms for detection and transmission methods), as the predicate NUVANT MCT System," suggesting that the algorithmic performance itself was not changed but rather confirmed to remain consistent.

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

The document does not explicitly state the type of ground truth used for algorithm validation. For arrhythmia detectors, ground truth typically involves manually annotated ECGs by cardiologists or other qualified medical professionals. Given that the algorithms are stated to be "identical to the predicate," it's reasonable to infer that the ground truth used for validating the original predicate device's algorithms would have been applied, and confirmed to perform similarly post-modification.

8. The sample size for the training set

The document does not provide any information regarding the sample size for a training set. This is a 510(k) for modifications to an existing device, and details about the original algorithm training would typically be in the initial 510(k) for the predicate device.

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

The document does not provide any information on how the ground truth for a training set was established. Similar to the previous point, such details would pertain to the development of the original algorithms in the predicate device.

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