(57 days)
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.
- The modified algorithm allows the devices to:
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.
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.