Search Results

The Vios Monitoring System (VMS) is intended for use by medically qualified personnel for physiological vital signs monitoring of adult (18+) patients in healthcare facilities. It is indicated for use in monitoring of 7-Lead ECG, heart rate, respiratory rate, pulse rate, functional oxygen saturation of arterial hemoglobin, non-invasive blood pressure (NIBP) continuously, and patient posture and activity. VMS allows for the input of non-invasive blood pressure and body temperature and can display data from peripheral devices. VMS can generate alerts when rate-based cardiac arrhythmias are detected and when physiological vital signs fall outside of selected parameters.

The non-invasive Blood Pressure Tracking feature is based on Pulse Arrival Time (PAT), which is obtained utilizing ECG and PPG signals following a calibration process using an FDA-cleared oscillometric blood pressure monitor. This feature is not intended for use in critical care environment.

The Vios Central Station Monitor (CSM) and Central Server (CS) Software (SW) is indicated for use by healthcare professionals for the purpose of centralized monitoring of patient data within a healthcare facility. The Vios CSM SW and CS SW receives, stores, manages, and displays patient physiological and waveform data and alarms generated by Vios proprietary patient vitals monitoring software.

The Vios Monitoring System (VMS) Model 2050 is a wireless mobile medical device platform that allows caregivers in healthcare settings to monitor patient vitals.

The VMS includes a proprietary monitoring software, Chest Sensor, Finger Adapter and Central Server and Central Monitoring Station.

The VMS BSM SW Model B2050 is stand-alone software that can receive, analyze, and display physiological vitals data from one or more patient-worn sensors via standard communication protocols (Bluetooth™). It runs on a commercial IT platform and is intended to be used in conjunction with the Vios Chest Sensor and Vios Lead Adapters and can support peripheral, medical grade, Bluetooth™-enabled devices.

The VMS Chest Sensor Model CS2050 is a small, patient-worn, non-sterile multiple use, and rechargeable sensor that acquires 3-channel ECG, bioimpedance, 2-channel pulse oximetry, and tri-axial accelerometer data. The sensor contains signal acquisition firmware (embedded software) and wirelessly communicates acquired data via standard communication protocols (Bluetooth™) to the BSM SW for analysis and display. The Chest Sensor has a button that, when pressed, sends a patient call alert to the BSM SW.

VMS Chest Sensor Adapter Models L2050F (Pulse Ox Finger Adapter) are plastic, non-sterile, patient-worn, multiple use pulse oxygenation sensors that connect to the Vios Chest Sensor and are secured to the patient via medical grade ECG electrodes.

The provided text describes a 510(k) clearance for the Vios Monitoring System Model 2050, focusing on the addition of a blood pressure tracking feature. Here's an analysis of the acceptance criteria and the study details based solely on the provided document:

Missing Information: It's important to note that the provided FDA 510(k) clearance letter is a summary document and does not contain the detailed clinical study report or the specific acceptance criteria with numerical performance targets. It states that the device meets "all consensus standards requirement" and that "results were within the acceptance criteria," but it does not define those criteria or present detailed performance data in a table format. Therefore, I will have to make assumptions about the typical acceptance criteria for Non-Invasive Blood Pressure (NIBP) devices based on the mentioned standards (ISO 81060-2, IEEE 1708, ISO 81060-3) and then state the general reported outcome from the document.

1. Table of Acceptance Criteria and Reported Device Performance

Given the lack of specific numerical acceptance criteria and performance data in the provided document, the table below will broadly reflect typical NIBP acceptance criteria based on the mentioned standards and the general statement of performance from the text.

Explanation of Assumption: The document explicitly states that "The clinical testing and analysis is performed according to applicable clauses from ISO 81060-2, IEEE 1708, and ISO 81060-3 for validation using reference invasive blood pressure measurement on the radial artery." ISO 81060-2 is the primary standard for non-invasive sphygmomanometers, which outlines specific statistical accuracy requirements (mean difference and standard deviation). Therefore, the acceptance criteria are assumed to be those specified in ISO 81060-2. The document does not provide numerical results for the Vios Monitoring System.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not explicitly stated in the provided document. The text mentions "a range of subjects, representative of the intended population."
• Data Provenance: Not explicitly stated. The document indicates a "clinical study" was performed, but does not specify the country of origin of the data or whether it was retrospective or prospective. Given it's a clinical study for validation, it is most likely prospective.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided in the document. The ground truth was established by "reference invasive blood pressure measurement on the radial artery," which is a direct, objective medical measurement, not typically requiring a panel of experts for interpretation in the same way as, for example, image interpretation.

4. Adjudication Method for the Test Set

This information is not applicable/provided as the ground truth for blood pressure measurement (invasive arterial line) is an objective, quantitative measurement that does not require expert adjudication in the same manner as subjective or qualitative assessments.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study (comparing human reader performance with and without AI assistance) is typically performed for diagnostic imaging or similar interpretation tasks where human perception and decision-making are aided by AI. For a vital signs monitor, the primary assessment is of the device's accuracy against a known reference, not its ability to assist human readers in interpretation.

6. If a Standalone (Algorithm Only) Performance Study Was Done

Yes, a standalone performance study was done. The clinical testing described for "Blood Pressure Tracking" assesses the algorithm's accuracy in autonomously generating blood pressure values from PAT (Pulse Arrival Time) against an invasive blood pressure reference. This is an assessment of the algorithm's standalone performance.

7. The Type of Ground Truth Used

The ground truth used for the blood pressure tracking feature was invasive blood pressure measurement on the radial artery. This is considered a gold standard and highly accurate method for blood pressure determination.

8. The Sample Size for the Training Set

The document does not provide information regarding the sample size for a training set. The descriptions focus on the validation study for the blood pressure tracking feature. It is implied that the algorithm was developed (trained) prior to this validation, but the details of that training are not included in this summary.

9. How the Ground Truth for the Training Set Was Established

The document does not provide information on how the ground truth for any training set was established. It only describes the ground truth for the clinical validation study (invasive blood pressure measurement on the radial artery) and the calibration process. The "calibration (initialization)" step uses an "FDA-cleared oscillometric blood pressure monitor" for initial coefficient determination, which is distinct from establishing ground truth for a large-scale training set.

Ask a specific question about this device