(85 days)
The Vector Event Grid Architecture System is intended for use in data collection from bedside and point of care biomedical devices and clinical information management systems either directly or through networks with independent bedside devices. The Vector Event Grid Architecture 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 VEGA System permits the transfer of data from biomedical and patient care devices to existing hospital information technology and electronic medical record systems. The VEGA System connects directly to biomedical devices and aggregates the data from multiple biomedical devices for transmission to electronic medical record systems. The VEGA System may also translate native biomedical device data into the HL7 standard as necessary.
The provided text is a 510(k) summary for the Nuvon, Inc. Vector Event Grid Architecture (VEGA) System, a device for collecting data from biomedical devices and clinical information management systems. It is not a detailed study report with specific acceptance criteria and performance metrics for a diagnostic or AI-driven device in the typical sense.
Therefore, much of the requested information cannot be extracted directly from this document. The document describes a data retrieval system rather than a device with diagnostic or analytical performance claims that would typically involve sensitivity, specificity, or other statistical measures.
However, I can extract the following information:
1. A table of acceptance criteria and the reported device performance:
The document does not provide a table of quantitative acceptance criteria or statistical performance metrics (e.g., sensitivity, specificity, AUC) because it's a data collection and transmission system, not a diagnostic one. Instead, it states qualitative performance outcomes.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Communication of biomedical device data from source devices | "Results of verification and validation activities have shown that the VEGA System biomedical device data are communicated from the source devices through the system in a manner consistent with the expected performance." |
| Functionality as intended | "In all instances the VEGA System functioned as intended..." |
| Fidelity of results | "...and the fidelity of the results observed was as expected." |
| Equivalence to predicate device for safety and effectiveness | "The minor technological differences between the VEGA System and its predicate devices raise no new issues of safety or effectiveness." |
| Substantially equivalent performance to predicate device | "Performance data demonstrate that the VEGA System has substantially equivalent performance to the Data Captor System." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not provided in the document. The document refers to "verification and validation activities" but does not specify the sample size, type of data used (e.g., specific biomedical device models, patient data), or its provenance.
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 applicable/not provided. The device is a data retrieval system, not one that makes clinical diagnoses requiring expert ground truth for its performance evaluation in the traditional sense. Its evaluation would focus on data integrity, transmission accuracy, and interoperability.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable/not provided. Adjudication methods are typically used for establishing ground truth in diagnostic studies, which is not the primary purpose of this device's performance evaluation as described.
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:
This information is not applicable/not provided. The VEGA System is a data retrieval and transmission system, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance would not be relevant to its function.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The document describes the VEGA System as functioning independently to collect and transmit data. The performance section implies a standalone evaluation of the system's ability to communicate data accurately from source devices. However, the term "standalone" in the context of an "algorithm" is more typically associated with AI-driven diagnostic tools. Here, the device's function as a data intermediary is evaluated.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The concept of "ground truth" in the diagnostic sense (e.g., pathology, expert consensus) is not applicable to this device. For this type of system, the "ground truth" would likely be the actual data generated by the biomedical devices, and the performance would be validated by comparing the transmitted data to the source data for accuracy, completeness, and fidelity. The document states "the fidelity of the results observed was as expected," implying such a comparison.
8. The sample size for the training set:
This information is not applicable/not provided. The VEGA system is described as a data retrieval architecture, not a machine learning or AI algorithm that would typically require a "training set" in the context of supervised learning.
9. How the ground truth for the training set was established:
This information is not applicable/not provided for the same reasons as point 8.
§ 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).