(293 days)
The ViSi Mobile Monitoring System is intended for use by clinicians and medically qualified personnel for single or multi-parameter vital signs monitoring of adult patients (18 years or older). It is indicated for ECG (3 or 5 lead-wire), respiration rate, noninvasive blood pressure (NIBP), continuous non-invasive blood pressure (cNIBP), non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, basic arrhythmia analysis (Ventricular Tachycardia, Ventricular Fibrillation, Asystole, Atrial Flutter) and alarm in hospital-based facilities; including general medical-surgical floors, intermediate care floors, and emergency departments.
Continuous non-invasive blood pressure (cNIBP) measurements have not been evaluated on patients during ambulation.
The basic arrhythmia analysis feature is intended for use on patients 18 years of age and older. It has not been evaluated on pediativ patients or neonates.
The arrhythmia analysis feature is intended for use by healthcation and treatification and treatment of arrhythmia events. Automated arrhythmia analysis is an adjunct to clinician review of the analysis should precede any therapeutic intervention.
The ViSi Mobile Monitoring System may be used as standalone devices or networked to a ViSi Mobile Remote Viewer through wireless 802.11 communication.
The ViSi Mobile Monitoring System is a lightweight, body-worn vital signs monitor featuring a high resolution, full color touch screen display, with visual and audible alarms and alerts. The ViSi Mobile Monitor is designed to continuously non-invasively measure ECG, basic arrhythmias [including ventricular tachycardia, ventricular fibrillation, asystole, and atrial fibrillation/atrial flutter], heart rate, SpO2, blood pressure, pulse rate, respiration rate, and temperature. The ECG, Sp02, and Respiration waveforms are viewable on demand. The ViSi Mobile Monitoring System is capable of one-time and continuous NIBP measurements.
The ViSi Mobile Monitoring System for basic arrhythmia analysis (Ventricular Tachycardia, Ventricular Fibrillation, Asystole, Atrial Fibrillation/Atrial Flutter) includes the following acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (ANSI/AAMI EC57: 2012) | Reported Device Performance (ViSi Mobile Monitoring System) |
|---|---|---|
| QRS Detection | (Not explicitly defined in the provided text, but implied as being comparable to predicate) | Comparable to predicate device |
| Arrhythmia Analysis | Based on ANSI/AAMI EC57: 2012 | Validated by comparison to AHA, MIT-BIH, CU, and NST databases |
| False Alarms | Minimized by artifact and unclassified rhythm detection | Artifact detection prevents noisy signals from being detected as beats; Unclassified rhythm for unclassifiable rhythms (>30s triggers technical alarm) |
Note: The document specifies that the basic arrhythmia analysis is based on the same technology as the currently cleared Monebo Technologies, Inc Arrhythmia library (K062282), which was adapted for real-time analysis. It also states the device has been validated by comparison to specific databases as prescribed by ANSI/AAMI EC57: 2012.
2. Sample Size Used for the Test Set and Data Provenance
The test set included data from the following databases:
- AHA (American Heart Association)
- MIT-BIH Arrhythmia Database
- CU (Creighton University Arrhythmia Database)
- NST (Northrop-Swales Transient Database)
The document does not detail the specific sample size (number of recordings or patients) used from each database, nor does it explicitly state the country of origin or whether the data was retrospective or prospective. However, these are established, publicly available retrospective databases commonly used for arrhythmia algorithm validation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The ground truth for the AHA, MIT-BIH, CU, and NST databases was established by expert consensus during the creation of these databases. The specific number and qualifications of experts involved in the original annotation of these databases are not provided in this document but are well-documented within the respective database literature.
4. Adjudication Method for the Test Set
The document does not explicitly describe an adjudication method for the test set beyond relying on the established ground truth of the referenced databases (AHA, MIT-BIH, CU, NST). These databases typically feature annotations derived from multiple expert reviews.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No Multi-Reader Multi-Case (MRMC) comparative effectiveness study is mentioned in the provided text, nor is there any effect size of human readers improving with AI vs without AI assistance. The study described focuses on standalone algorithm performance against established databases.
6. Standalone Performance Study
Yes, a standalone (algorithm only without human-in-the-loop performance) study was done. The ViSi Mobile Monitoring System's basic arrhythmia analysis was validated by comparison to the AHA, MIT-BIH, CU, and NST databases as prescribed in ANSI/AAMI EC57: 2012. The QRS detection sensitivity of the ViSi System was reported as comparable to the predicate device.
7. Type of Ground Truth Used
The type of ground truth used was expert consensus based on the established annotations within the AHA, MIT-BIH, CU, and NST databases.
8. Sample Size for the Training Set
The document does not provide specific details on the sample size used for the training set. It states that the basic arrhythmia analysis is based on the same technology as a previously cleared device (Monebo Technologies, Inc Arrhythmia library, K062282). This implies that a substantial training set was likely used during the development of the original algorithm, and possibly for adaptive training, but no specific numbers are given for the ViSi Mobile's training.
9. How the Ground Truth for the Training Set Was Established
Similarly, the document does not explicitly state how the ground truth for the training set was established. Given that the algorithm is based on a previously cleared library, it is highly probable that the training data and its ground truth were established through similar expert-annotated ECG datasets as those used for validation (e.g., subsets or similar types of data to the AHA, MIT-BIH databases).
§ 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.