(245 days)
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)
| Feature/Metric | Acceptance Criteria | Reported Device Performance | Notes on Study and Data Provenance |
|---|---|---|---|
| ECG Monitoring | Not specified in document | Conforms to relevant standards (e.g., 60601-2-27) | General statement on "Reliability and Performance Testing" and standards compliance. No specific performance metrics (e.g., accuracy, sensitivity, specificity for arrhythmia detection) are provided. |
| Heart Rate Monitoring | Not specified in document | Conforms to relevant standards (e.g., 60601-2-27) | |
| Pulse Rate Monitoring | Not specified in document | Conforms to relevant standards | |
| Functional Oxygen Saturation (SpO2) | Not specified in document | Conforms to relevant standards (e.g., 60601-2-27 suggests pulse oximetry) | |
| Axillary Temperature | Not specified in document | Conforms to relevant standards (e.g., 880.2910) | |
| Non-Invasive Blood Pressure (NIBP) | Not specified in document | The device "allows for the input of non-invasive blood pressure," implying it displays external NIBP data rather than measures it directly. No performance for NIBP measurement is stated for the VMS itself. | |
| Alert Generation (Arrhythmias) | Not specified in document | "VMS can generate alerts when rate-based cardiac arrhythmias are detected." Conforms to relevant standards (e.g., 60601-1-8). | No specific performance metrics (e.g., sensitivity, positive predictive value for arrhythmia detection, alarm limits) provided. |
| Alert Generation (Physiological Vital Signs) | Not specified in document | "VMS can generate alerts when physiological vital signs fall outside of selected parameters." Conforms to relevant standards (e.g., 60601-1-8). | No specific performance metrics (e.g., accuracy of threshold detection, alarm limits) provided. |
| Electrical Safety | Conformance to IEC 60601-1, 60601-1-2, 60601-1-8, 60601-2-27, and 60601-2-49 | Confirmed through non-clinical testing | Bench testing |
| Electromagnetic Compatibility (EMC) | Conformance to IEC 60601-1-2 | Confirmed through non-clinical testing | Bench testing |
| Usability | Conformance to IEC 62366 | Confirmed through "Usability Testing (Formative and Summative)" | Bench testing |
| Risk Management | Conformance to ISO 14971 | Confirmed through non-clinical testing | Bench testing |
| Software Development Lifecycle | Conformance to IEC 62304 | Confirmed through non-clinical testing | Bench testing |
| Biocompatibility | Conformance to ISO 10993 | Confirmed through non-clinical testing | Bench testing |
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.
§ 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).