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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 (RESP), heart rate (HR), noninvasive blood pressure (NIBP), continuous noninvasive blood pressure (cNIBP), noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), skin temperature (TEMP), posture tracking and basic arthythmia (Ventricular Tachycardia, Ventricular Fibrillation, Asystole, Atrial Fibrillation) analysis 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 pediatric patients.

The arrhythmia analysis feature is intended for use by healthcare professionals trained in the identification and treatment of arrhythmia events. Automated arrhythmia analysis is an adjunct to clinical assessment; clinician review of the analysis should precede any therapeutic intervention.

The ViSi Mobile Monitoring System may be used as standalone devices or networked to ViSi Mobile Remote Viewers through wireless 802.11 communication.

The Visl Mobile Insight is an optional secondary notification system that communicates alarms directly to an assigned caregiver. It is intended to supplement the primary alarming devices which originate in the ViSI Mobile patient-worn device.

The ViSi Mobile Monitoring System is a patient worn, portable, battery operated, continuous physiological monitoring device intended for the monitoring of ECG (3 or 5 lead-wire), respiration rate (RESP), heart rate (HR), non-invasive blood pressure (NIBP), continuous non-invasive blood pressure (cNIBP), non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), skin temperature (SKIN TEMP), posture tracking and alarms, basic arrhythmia analysis (ventricular fibrillation, ventricular tachycardia, asystole, atrial fibrillation) and alarms.

The ViSi Mobile Monitoring System consists of the patient worn devices, disposables, backup battery, patient data server and remote viewer.

This document (K180472) is a 510(k) premarket notification for the ViSi Mobile Monitoring System. The focus of the provided text is to demonstrate substantial equivalence to a predicate device, primarily by highlighting changes and comparing technical characteristics and performance, especially concerning arrhythmia detection.

Based on the provided text, here's a detailed breakdown of the acceptance criteria and the study proving the device meets them:

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

The document does not explicitly present a "table of acceptance criteria" in the traditional sense for the acceptance of the device as a whole. Instead, it presents performance metrics against recognized standards (ANSI/AAMI EC57: 2012) for its arrhythmia detection algorithm, comparing the improved "Proposed Device" (Subject Device) with a "Reference Device A" (K142827), which is a previously cleared version of the ViSi Mobile Monitoring System.

Here's a table derived from the provided "C. Atrial Fibrillation Comparison" and "E. ALARM TEST COMPARISON" sections, focusing on the arrhythmia detection performance:

The study that proves the device meets the acceptance criteria is primarily non-clinical, using established databases.

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

The test set utilizes publicly available, established databases:

• AHA (American Heart Association)
• MIT-BIH (Massachusetts Institute of Technology - Beth Israel Hospital Arrhythmia Database)
• CU (Creighton University Ventricular Tachyarrhythmia Database)
• NST

The specific sample sizes (e.g., number of ECG recordings or patients) from these databases are not explicitly stated in the provided text. The provenance is from these known databases, which are widely accepted for arrhythmia algorithm testing. The data within these databases is retrospective.

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

The document states: "The arrhythmia analysis is based on the same technology as the currently cleared Monebo Technologies, Inc Arrhythmia library (K062282), which has been adapted for real time analysis in the ViSi System. The ViSi Monitoring System arrhythmia analysis has been validated by comparison to the AHA, MIT-BIH, CU, and NST databases as prescribed in ANSI/AAMI EC57: 2012."

The ground truth for these databases (AHA, MIT-BIH, CU, NST) was established by experts, typically cardiologists or electrophysiologists, during the creation of the databases. The specific number and qualifications of these experts are not detailed within this 510(k) document but are inherent to the accepted nature of these standard databases.

4. Adjudication method for the test set

The document does not describe an adjudication method for the test set data itself. The ground truth for the test sets (AHA, MIT-BIH, CU, NST databases) was established independently by the creators of those databases.

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. A multi-reader multi-case (MRMC) comparative effectiveness study involving human readers is not described in this document. The study focuses purely on the algorithm's performance against established gold-standard databases, comparing an updated algorithm to a previous version and recognized standards. The device is not presented as an AI-assistance tool for human readers but rather as a standalone monitoring system with an integrated arrhythmia detection algorithm.

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

Yes. The performance evaluation presented is a standalone (algorithm only) performance assessment. The tables show the algorithm's sensitivity and positive predictivity for various arrhythmia events (VF/VT, AFIB) when processing the specified ECG databases. The context further reinforces this, stating "Automated arrhythmia analysis is an adjunct to clinical assessment; clinician review of the analysis should precede any therapeutic intervention," indicating it acts as an aid rather than requiring human modification of its output for the test.

7. The type of ground truth used

The ground truth used for the performance testing is expert consensus from established, recognized ECG databases (AHA, MIT-BIH, CU, NST). These databases contain expert-annotated ECG waveforms, which serve as the gold standard for evaluating arrhythmia detection algorithms.

8. The sample size for the training set

The document does not explicitly state the sample size of the training set used to develop or refine the arrhythmia detection algorithm. It mentions that "The arrhythmia analysis is based on the same technology as the currently cleared Monebo Technologies, Inc Arrhythmia library (K062282)," which implies that the training might have occurred prior to this submission (or the core technology was pre-trained).

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

The document does not explicitly detail how the ground truth for the training set was established. Given that the algorithm is based on (or an adaptation of) the Monebo Technologies, Inc Arrhythmia library, it's highly probable that the training also utilized similar expert-annotated ECG datasets or proprietary clinical data. The document does state that the arrhythmia algorithm was "Rewritten to improve specificity and detection metrics" and later "New arrhythmia detection algorithm to improve arrhythmia detection accuracy and positive predictivity," implying development and testing that would have involved ground truth data.

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CorSens Device records vibrational waveforms produced by the heart contractions and transmitted to the chest wall. CorSens Device may be used as a tool to measure the timing of part of the cardiac cycle for adult population.

CorSens Device senses and analyzes the mechanical movement of the heart. This is accomplished by 3 standard ECG electrodes for the ECG signal and with a suitable miniature electronic accelerometer for the mechanical motions.

The CorSens Device, a Ballistocardiograph, records vibrational waveforms produced by heart contractions to measure the timing of part of the cardiac cycle in adults.

Here's an analysis of its acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in a table format. However, it indicates a high-level performance expectation and makes a direct comparison to an established clinical method.

2. Sample Size and Data Provenance for Test Set

The provided document does not explicitly detail a specific 'test set' with a defined sample size for a clinical study comparing the CorSens Device to an echocardiogram. It refers to a "comparison test" with echocardiogram, stating: "In addition to the verification and validation testing, a comparison test with the current common clinical practice to measure the timing of the events in the cardiac cycle, an Echocardiogram, was conducted."

Without further information, the specific sample size, country of origin, or whether the data was retrospective or prospective cannot be determined from this document.

3. Number and Qualifications of Experts for Ground Truth

The document does not specify the number or qualifications of experts used to establish ground truth for any test set. The ground truth (echocardiogram measurements) would typically be established by trained sonographers and/or cardiologists.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method for the comparison test with echocardiogram.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. Therefore, information on the effect size of human readers improving with or without AI assistance is not applicable or provided.

6. Standalone (Algorithm Only) Performance Study

The document indicates that "the proposed CorSens Device safety and the efficacy of the system were established by performance lab tests and Software V&V." While this suggests evaluation of the device's technical performance in isolation, it does not specifically describe a 'standalone (algorithm only without human-in-the-loop performance)' study in the way it might be discussed for an AI-driven diagnostic algorithm. The device is a measurement tool, and its 'performance' inherently involves its ability to capture and process data to produce timing measurements.

7. Type of Ground Truth Used

For the comparison test, the ground truth used was echocardiogram. The text explicitly states: "a comparison test with the current common clinical practice to measure the timing of the events in the cardiac cycle, an Echocardiogram, was conducted."

8. Sample Size for the Training Set

The document does not mention any specific training set or its sample size. This implies that the device's core functionality does not rely on a machine learning model that requires a discrete training phase with labeled data in the way many contemporary AI devices do. The device's operation is based on established biophysical principles of measuring vibrational waveforms.

9. How Ground Truth for the Training Set Was Established

Since no training set is mentioned as part of the device's development or validation process in this document, the method for establishing its ground truth is not applicable or provided. The device likely operates on fixed algorithms rather than a trained machine learning model.

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