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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, and patient posture and activity. VMS allows for the input of body temperature, and can display data from peripheral devices. VMS can generate alerts when rate-based carthythmias are detected and when physiological vital signs fall outside of selected parameters.

The Vios Monitoring System (VMS) Model 2050 is a wireless mobile medical device platform that allows caregivers in healthcare settings to monitor patient vitals. VMS includes Vios-proprietary monitoring software and a Vios-proprietary vitals sensor with two Vios-proprietary adapters. It is compatible with a medical grade, Bluetooth™-enabled NIBP cuff. 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 L2050E (Pulse Ox Ear Adapter) and 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 is a 510(k) Summary for the Vios Monitoring System™ Model 2050. This document outlines the device's intended use, regulatory information, and a summary of the testing performed to demonstrate substantial equivalence to predicate devices.

However, the document does not contain specific details about acceptance criteria, reported device performance metrics (e.g., sensitivity, specificity, accuracy for arrhythmia detection), the sample size of a test set, the number and qualifications of experts for ground truth establishment, adjudication methods, or effects of AI assistance on human readers.

The text focuses on hardware and software description, regulatory compliance, and general types of testing conducted (electrical safety, biocompatibility, usability, software development lifecycle, specific clinical testing for pulse oximetry and respiratory rate). It mentions that "VMS can generate alerts when rate-based cardiac arrhythmias are detected," but does not provide performance metrics for this specific function in the context of acceptance criteria.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based solely on the provided text. The information required for your questions (especially points 1-7, and 9) is not present in this 510(k) Summary.

Here's an overview of what is mentioned in relation to testing, which is very high-level:

Summary of Non-Clinical, Clinical, and Conformance Testing:
The document states that "The safety, effectiveness, and substantial equivalency of the VMS Model 2050 have been confirmed through the following non-clinical, clinical, and conformance testing:"

• Non-clinical:

  • Electrical safety, EMC, and vitals sign monitoring standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8, IEC 60601-2-27, IEC 60601-2-49, EC53)
  • Biocompatibility standards (ISO 10993)
  • Usability and human factors standards (EN 62366)
  • Transportation Simulation testing (ASTM D4169-16)
  • Software development life cycle (EN 62304)
  • Risk Management (ISO 14971)

• Clinical:

  • Pulse oximetry clinical testing (IEC 80601-2-61)
  • Respiratory Rate clinical testing

Missing Information:

• Acceptance Criteria Table & Reported Performance: Not provided for any specific vital sign or arrhythmia detection.
• Sample size (test set) & Data Provenance: Not detailed. It only mentions "clinical testing."
• Number & Qualifications of Experts, Adjudication Method: Not specified for any ground truth establishment.
• MRMC Study / AI Assistance: Not mentioned. The device generates alerts for rate-based arrhythmias, but there's no comparative study with human readers described or any 'AI' effect size.
• Standalone Performance: While the device has an algorithm for arrhythmia detection, the specific performance metrics (sensitivity, specificity) are not reported here.
• Type of Ground Truth: For pulse oximetry and respiratory rate clinical testing, it's implied that a reference standard was used as per relevant IEC standards, but the exact method (e.g., expert consensus on ECG, pathology) for arrhythmia detection is not disclosed.
• Training Set Sample Size: Not mentioned, as this document focuses on substantial equivalence testing rather than algorithm development.
• Ground Truth for Training Set: Not mentioned.

In summary, while the document indicates that various tests were performed to support substantial equivalence, it does not provide the granular detail needed to answer your questions regarding acceptance criteria and performance metrics for the device's diagnostic or alerting capabilities.

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