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510(k) Data Aggregation
(42 days)
The Nuvon Vitals Charting System is an accessory to the Nuvon VEGA System (K103125) and is intended to display patient information and surveillance of monitored patients at the point of care location and at a remote supplementary care location through wide area networking technology. The Nuvon Vitals Charting System is only intended to display physiologic and other patient information and intended for use by clinicians as a diagnostic aid, and not as a replacement for direct viewing of any of the monitored devices from which it obtains its data. The Nuvon Vitals Charting System is not intended for monitoring purposes, nor is it intended to control any of the biomedical devices and information systems with which it interconnects.
The Nuvon Vitals Charting System is a software only system that permits the display of data from biomedical, patient care devices, and ancillary hospital systems (e.g.: laboratory and hospital admission, discharge and transfer systems). The system can be used to review and validate the data for transfer to existing hospital information technology and electronic medical record systems. Additionally, the system can be used for patient surveillance to evaluate trends in patient data.
The Nuvon Vitals Charting System is a software-only system designed to display data from various biomedical, patient care devices, and hospital information systems. It's intended for use by clinicians as a diagnostic aid for patient information display and surveillance, but not as a replacement for direct viewing of monitored devices or for direct patient monitoring.
Here's an analysis of the acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Functional Performance | Unit Testing: Functions verified for valid operation per requirements and design. | "Results of verification and validation activities have shown that the Nuvon Vitals Charting System displays biomedical device data communicated from the source devices through the system in a manner consistent with the expected performance." |
| Integration and System Testing: Functions operate within the scope of the larger VEGA System. | "Results of verification and validation activities have shown that the Nuvon Vitals Charting System displays biomedical device data communicated from the source devices through the system in a manner consistent with the expected performance." | |
| Non-Functional Performance | Performance/Non-functional testing: Support for multiple simultaneous users and demonstration of key functional performance over time to illustrate scalability without appreciable degradation. | "Results of verification and validation activities have shown that the Nuvon Vitals Charting System displays biomedical device data communicated from the source devices through the system in a manner consistent with the expected performance." |
| Overall Equivalence | Substantial Equivalence to predicate devices (VISICU ARGUS, K012171 and Airstrip Remote Patient Monitoring Viewing System, K121871) in intended uses, indications, technological characteristics, and principles of operation. Minor technological differences raise no new issues of safety or effectiveness. | "The Nuvon Vitals Charting System has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate devices. The minor technological differences between the Nuvon Vitals Charting System and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the Nuvon Vitals Charting System meets its specifications and intended use, and thus is substantially equivalent performance to the VISICU ARGUS System and the Airstrip Patient Monitoring System." |
2. Sample size used for the test set and the data provenance
The provided text does not specify a numerical sample size for any test sets used.
The data provenance (e.g., country of origin, retrospective or prospective) is not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not mention the use of experts or a ground truth established by experts for the test set. The validation seems to rely on the system's ability to accurately display data consistent with expected performance and its functional requirements.
4. Adjudication method for the test set
The document does not describe any adjudication method like 2+1, 3+1 for establishing ground truth, as ground truth is not explicitly mentioned in the context of expert review.
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
A multi-reader multi-case (MRMC) comparative effectiveness study was not performed or reported. This device is described as a "display system" and "diagnostic aid," not an AI algorithm intended to assist human readers in interpretation or diagnosis in the way an imaging AI might. There's no mention of AI assistance for "human readers" or an "effect size" of such assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is a standalone software system (algorithm only in a sense that it's a software displaying data), but the "standalone performance" referred to in AI/ML contexts (where an algorithm makes a diagnostic decision without human input) is not applicable here. The system's function is to display data, and its performance centers on accurate data transfer and display, not on making independent diagnostic decisions. The stated intended use is as a "diagnostic aid," with clinicians using it, not as a replacement for direct viewing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The term "ground truth" in the strict sense of a reference standard established by experts or confirmed by pathology/outcomes data is not explicitly used or described in the context of device performance validation. The validation focused on whether the system "displays biomedical device data communicated from the source devices through the system in a manner consistent with the expected performance" and "meets its specifications and intended use." This implies that the "truth" for this system is the accurate representation of the data generated by the source biomedical devices, validated against the expected output based on functional requirements and system integration.
8. The sample size for the training set
The document does not mention a training set or any machine learning/AI model training. This device is described as a charting and display system, not a system that uses machine learning in a way that requires a distinct training and test set in the typical AI/ML validation paradigm.
9. How the ground truth for the training set was established
As no training set or machine learning components are mentioned, the concept of establishing ground truth for a training set is not applicable to this submission.
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