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

The Vios CS SW enables the Vios Monitoring System to be used in networked mode within a healthcare IT network and runs on commercial IT equipment. The Vios CS SW operates as a communications hub that can pass the data generated by Vios proprietary vitals monitoring software to one or more remote viewing software applications, without modifying the data. The Vios CSM SW is the remote viewing software of the Model 2050 system. It allows up to 16 devices to be displayed on one screen and runs on a commercial IT device that satisfies defined Vios-defined technical specifications.

The provided text does not contain information about the acceptance criteria and study proving device performance for Vios Central Station Monitor/Central Server Software Model 2050. The document is an FDA 510(k) clearance letter and summary, which confirms substantial equivalence to a predicate device but does not detail specific performance studies with acceptance criteria, sample sizes, ground truth establishment, or expert involvement.

Therefore, I cannot fulfill your request for the detailed performance information based on the provided input.

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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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The Vios Monitoring System (VMS) is intended for use by medically qualified personnel for physiological and vital signs monitoring of adult (18+) patients in healthcare facilities. It is indicated for use in monitoring of ECG, heart rate, pulse rate, functional oxygen saturation of arterial hemoglobin, and axillary temperature. VMS allows for the input of non-invasive blood pressure 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 Vios Monitoring System includes the following components:
Bedside Monitor Software (BSM SW): Medical device software that analyzes and/or displays vitals data received via standard communication protocols from one or more compatible sensors or peripheral devices. The software runs on standard commercial IT equipment and can operate in stand-alone mode or networked mode using standard networking protocols. In networked mode, it can share its display with one or more

The provided 510(k) summary for the Vios Monitoring System (K150992) indicates that safety and effectiveness were confirmed through non-clinical testing and conformance to standards. However, it does not contain specific acceptance criteria or detailed study results for device performance.

The document lists general standards compliance for various aspects like electrical safety (60601), electromagnetic compatibility (60601), usability (62366), risk management (14971), software development lifecycle (62304), and biocompatibility (10993). It also mentions "Reliability and Performance Testing."

Since the provided text does not contain the specific details required, I can only create a table that highlights the absence of this information in the document.

Summary of Device Acceptance Criteria and Performance (Based on Provided Document)

Detailed Answers to Specific Questions:

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

• See table above. The document primarily states conformance to standards rather than providing specific quantifiable acceptance criteria and performance results for the physiological monitoring functions.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• The document does not specify sample sizes for performance testing related to ECG, heart rate, SpO2, or temperature.
• Data provenance (country of origin, retrospective/prospective) is not mentioned. The "Non-Clinical Testing" section describes "bench testing," "Usability Testing (Formative and Summative)," "Reliability and Performance Testing," and "Transportation Simulation Testing." These are generally laboratory or in-house tests rather than clinical studies with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• This information is not provided in the document. The testing described appears to be technical validation against standards and internal benchmarks, not clinical studies requiring expert ground truth establishment for diagnostic performance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• This information is not provided and is typically relevant for clinical studies involving human interpretation or subjective measurements, which are not detailed here.

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

• The provided document does not mention or describe any MRMC comparative effectiveness study. The Vios Monitoring System is a vital signs monitor, and the context of AI assistance for human readers/interpretation, as seen in imaging devices, does not appear to be directly applicable based on this submission.

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

• The document focuses on the Vios Monitoring System as a whole device, a "Vitals signs monitor." The mention of "alerts when rate-based cardiac arrhythmias are detected" indicates an algorithmic component. However, specific standalone performance metrics (e.g., sensitivity, specificity, accuracy for arrhythmia detection) of these algorithms are not detailed in the provided summary. The testing refers to the system as a unit conforming to standards.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• The document describes "non-clinical testing" and "standards compliance." For technical specifications (like electrical safety, EMC), the ground truth would be the defined parameters of the standards themselves (e.g., voltage limits, frequency ranges, signal characteristics). For physiological measurements, it would typically involve comparison to a recognized gold standard measurement device during bench or simulated testing. Specific details of these "ground truths" beyond "standards compliance" are not provided.

8. The sample size for the training set

• The document describes non-clinical testing and standards compliance. It does not mention any "training set" as would be relevant for machine learning or AI algorithm development. The phrase "software development lifecycle (62304)" suggests robust software engineering practices, but not necessarily data-driven training in the AI sense.

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

• Since a "training set" is not mentioned in the context of AI/ML, the method for establishing its ground truth is also not applicable/not provided by this document.

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