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.

• Mean difference $\le \text{5 mmHg}$
• Standard deviation $\le \text{8 mmHg}$
  (Requirements per ISO 81060-2) | "The results were within the acceptance criteria, similar to the predicate device." |

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

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, functional oxygen saturation of arterial hemoglobin, non-invasive blood pressure and activity. VMS allows for the input of body temperature, and can display data from peripheral devices. VMS can generate alerts when the physiological vital signs fall outside of selected parameters.

VMS can also generate alerts when cardias arrhythmias (Tachycardia, Asystole, Ventricular Fibrillation and Atrial Fibrillation/ Atrial Flutter) are detected.

The ECG rhythm analysis is intended for use by medified professionals in the identification of arrhythmia events and to aid in clinical review of arrhythmias and medical interventions.

The Vos 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 CSMCS SW receives, stores, and displays patient physiological and waveform data and alams 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,

The Vios Monitoring System (VMS) Model 2050 was evaluated for its arrhythmia detection features, specifically assessing its performance against the ANSI/AAMI EC57:2012 standard and additional database records.

Here's a breakdown of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily references compliance with the ANSI/AAMI EC57:2012 standard for cardiac rhythm and ST-segment measurement algorithms. While specific numerical acceptance criteria (e.g., minimum sensitivity, positive predictivity) for each arrhythmia are not explicitly listed in the provided summary, the study's conclusion of meeting "performance requirements as outlined in the consensus standard ANSI/AAMI EC57:2012" implies that the device achieved the performance thresholds defined within that standard for the tested arrhythmias.

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

The document states that the device's performance was evaluated using:

• Records from the ANSI/AAMI EC57 standard. This standard often utilizes a combination of standard ECG databases (e.g., MIT-BIH Arrhythmia Database).
• Additional records from LTAF, AAEL, and VFDB databases.

The specific sample sizes (number of patients or ECG recordings) for each arrhythmia or for the combined test set are not provided in the summary. The provenance of LTAF, AAEL, and VFDB databases is not detailed; however, these are generally recognized public databases of ECG recordings used for algorithm testing, often comprising retrospective data.

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

The document does not state the number of experts used or their specific qualifications for establishing the ground truth of the test set. For publicly available and widely used databases like those mentioned (MIT-BIH, LTAF, AAEL, VFDB), the ground truth labels are typically established by multiple expert cardiologists or electrophysiologists using established criteria, often after multiple review rounds. However, this specific information is not in the provided text.

4. Adjudication Method for the Test Set:

The document does not specify the adjudication method used (e.g., 2+1, 3+1). For standard ECG databases, ground truth is usually established via expert consensus, which inherently involves an adjudication process, but the specific mechanics are not described here.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

The document does not indicate that a multi-reader multi-case (MRMC) comparative effectiveness study was done to assess how much human readers improve with AI vs. without AI assistance. The testing described is focused on the standalone performance of the device's arrhythmia detection algorithm.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance:

Yes, a standalone performance evaluation was done. The summary explicitly states: "The non-clinical tests for evaluation of performance of Vios system with the addition of arrhythmia alarms is based on ANSI/AAMI EC57, showing substantial equivalence to the predicate (K180472). The subject device's performance was also evaluated using additional records from LTAF, AAEL, and VFDB database..." This describes the algorithm's performance without direct human intervention as part of the detection process.

7. Type of Ground Truth Used:

The ground truth for the test was established through expert consensus/annotations from well-known ECG databases (ANSI/AAMI EC57, LTAF, AAEL, and VFDB). These databases contain ECG recordings that have been meticulously reviewed and annotated by medical experts (typically cardiologists or electrophysiologists) to identify and label different cardiac events and arrhythmias,
Pathology and outcomes data are not mentioned as sources for ground truth in this context.

8. Sample Size for the Training Set:

The document does not specify the sample size used for the training set of the Vios Monitoring System's arrhythmia detection algorithm.

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

The document does not specify how the ground truth for the training set was established. However, it is common practice for such algorithms to be trained on large, expertly annotated ECG datasets, similar to those used for testing (expert consensus/annotations).

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device