(206 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 (18 years or older) patients. It is indicated for ECG (3 or 5 leadwire), respiration rate, non-invasive blood pressure (NIBP), continuous non-invasive blood pressure (cNIBP), non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, and skin temperature in hospital-based facilities; including general medical-surgical floors, intermediate care floors, and emergency departments.
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, heart rate, SpO2, blood pressure, pulse rate, respiration rate, and temperature. The ECG, SpO2, and Respiration waveforms are viewable on demand. The ViSi Mobile Monitoring System is capable of one-time and continuous NIBP measurements.
Here's an analysis of the provided text regarding the acceptance criteria and study for the ViSi Mobile Monitoring System:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (from ISO 81060-2 & AAMI/ANSI SP10) | Reported Device Performance (ViSi System) |
|---|---|---|
| Intermittent NIBP MAP (Mean Error) | ≤ ± 5 mmHg | Meets criteria |
| Intermittent NIBP MAP (Standard Deviation) | ≤ 8 mmHg | Meets criteria |
| cNIBP (Mean Error) | ≤ ± 5 mmHg (as per ISO 81060-2) | Meets criteria |
| cNIBP (Standard Deviation) | ≤ 8 mmHg (as per ISO 81060-2) | Meets criteria |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set. It mentions "clinical performance validation," but provides no numbers.
The data provenance is not specified regarding country of origin. The studies were clinical performance validations, which implies prospective data collection, but this is not explicitly stated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
The document does not mention the use of experts to establish ground truth for the test set. Instead, it states that the ViSi's MAP measurement was "validated by comparison to an intra-arterial reference." This indicates that invasive, direct arterial blood pressure measurements were used as the gold standard for comparison.
4. Adjudication Method for the Test Set
No adjudication method is mentioned as the ground truth was established by direct intra-arterial measurements rather than expert review.
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. This device is a vital signs monitor and does not involve "human readers" interpreting images or data that AI would assist with in the typical sense of MRMC studies.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the studies conducted were standalone performance evaluations of the device's ability to accurately measure blood pressure. The performance criteria (mean error and standard deviation) are algorithm-only metrics comparing the device's output to a reference standard.
7. The Type of Ground Truth Used
The ground truth used for both intermittent NIBP MAP and cNIBP was intra-arterial reference measurements. This is considered a gold standard for blood pressure measurement.
8. The Sample Size for the Training Set
The document does not explicitly state the sample size for a training set. This is because the device's performance validation is based on clinical testing against a reference standard, not a machine learning model that requires a distinct training and testing set. The "auto-calibration to NIBP measurements" mentioned for cNIBP implies a form of continuous adaptation, but doesn't define a traditional "training set" in the context of supervised learning.
9. How the Ground Truth for the Training Set Was Established
Since a traditional "training set" in the machine learning sense is not applicable or explicitly mentioned for this device's validation, the method for establishing its ground truth is also not provided. Any internal calibration or learning processes would likely use intra-arterial or NIBP reference measurements as their "truth."
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).