(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 patients. It is indicated for ECG (3 or 5 leadwire), respiration rate (RESP), heart rate (HR), non-invasive blood pressure (NIBP), non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), and skin temperature (TEMP) in hospital-based facilities; including general medical-surgical floors, intermediate care floors, and emergency departments.
The ViSi Mobile Monitoring System is a lightweight, portable patient vital signs monitor featuring a high resolution, full color touch screen display, with visual and audible alarms and alerts. The ViSi Mobile Monitor is body-worn and designed to continuously measure ECG, heart rate, SpO2, pulse rate, respiration rate, and temperature. The ECG, SpO2, and Respiration waveforms are viewable on demand. NIBP can be measured as a onetime measurement, or it can be measured automatically at predefined intervals
The provided text describes the Sotera Wireless ViSi Mobile Monitoring System and references a clinical study for its NIBP measurement method. However, it does not provide explicit acceptance criteria with specific numerical performance targets or detailed results of a study that directly proves the device meets these criteria in a tabulated format.
The text states:
"The validity of this method [NIBP measurement on inflation] was confirmed in an ISO 81060-2 compliant clinical study demonstrating that this method of blood pressure meets the requirements of the standard in terms of accuracy and variability."
Based on this, here's what can be inferred and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (from ISO 81060-2) | Reported Device Performance |
|---|---|---|
| NIBP | Meets requirements of ISO 81060-2 for accuracy and variability | "meets the requirements of the standard in terms of accuracy and variability" |
Missing Information: Specific numerical values for accuracy (e.g., mean difference and standard deviation) and variability (e.g., standard deviation of differences) as defined by ISO 81060-2 are not provided in the document.
2. Sample Size and Data Provenance for the Test Set
- Sample Size: Not specified for the NIBP clinical study.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). However, clinical studies for medical devices are typically prospective.
3. Number of Experts and Qualifications for Ground Truth
- This question is not applicable in the context of device performance testing against a standard like ISO 81060-2 for NIBP. The "ground truth" for blood pressure measurement in such studies typically refers to a reference method (e.g., intra-arterial catheter) or a highly accurate sphygmomanometer used by trained clinicians, not "experts" establishing a diagnosis. The document does not specify the ground truth method.
4. Adjudication Method for the Test Set
- Not applicable in this context. Testing against a standard for a physiological measurement device usually involves comparing the device's readings to a reference method, not an adjudication process by multiple experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done, or at least not described in this document. This type of study is more common for diagnostic imaging AI systems where human readers interpret medical images. The ViSi Mobile Monitoring System is a vital signs monitor, not an image interpretation device.
6. Standalone Performance Study
- Yes, a standalone study was performed. The NIBP clinical study is a standalone performance study, as it evaluates the device's ability to measure blood pressure against a standard, without human interpretation of the output.
7. Type of Ground Truth Used
- The document states the NIBP method "meets the requirements of the standard in terms of accuracy and variability." While not explicitly stated, the ground truth for an ISO 81060-2 compliant clinical study for NIBP typically involves:
- Simultaneous measurements: The device under test and a validated reference method (e.g., intra-arterial measurement or a highly accurate auscultatory method performed by trained operators) are used simultaneously.
8. Sample Size for the Training Set
- Not applicable as this document describes performance testing of a medical device against a standard, not the development of an AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable (see point 8).
§ 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).