(59 days)
The Vital Sync TM Informatics Manager is software that is intended to route and store medical device data and device diagnostic information from supported devices to the Electronic Medical Record (eMR) and Clinical Information System (CIS).
The Vital Sync™ Virtual Patient Monitoring Platform is a remote monitoring platform that displays physiologic data, waveforms and alarms routed through the Vital Sync™ Informatics Manager for supported devices. The Vital Sync™ Virtual Patient Monitoring Platform is intended to be used by healthcare professionals for the following purposes:
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To remotely consult regarding a patient's status
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To remotely review other standard or critical near real-time patient data, waveforms and alarms in order to utilize this information to aid in clinical decisions and deliver patient care in a timely manner.
WARNING: The Vital Sync™ Informatics Manager & Virtual Patient Monitoring Platform are intended to supplement and not to replace any part of the hospital's device monitoring. Do not rely on the Vital Sync™ Informatics Manager & Virtual Patient Monitoring Platform as the sole source of alarms.
The Vital Sync™ Informatics Manager (IM) & Virtual Patient Monitoring Platform (VPMP) is software that routes parameters, waveforms and alarms from connected devices and displays them on any device that is web-enabled. The Vital Sync™ IM & VPMP can utilize the hospital's network and existing hardware for installation and display or an optional server pre-loaded with the Vital Sync software and off the shelf operating system can be provided. The Vital Sync™ Informatics Manager & Virtual Patient Monitoring Platform does not alter the parameters, waveforms and alarms displayed and does not control any of the medical devices connected.
The new features on the subject Vital Sync™ Informatics Manager & Virtual Patient Monitoring Platform include smart alarms, ADT connectivity and alarm forwarding to 30 party.
The provided document describes the Vital Sync™ Informatics Manager & Virtual Patient Monitoring Platform (K140339). However, it does not contain specific acceptance criteria, detailed study results with performance metrics, or information about sample sizes for test/training sets, expert qualifications, or adjudication methods.
Instead, the document focuses on demonstrating substantial equivalence to predicate devices through non-clinical evidence, primarily system-level verification, user interface verification, and usability validation. It explicitly states, "N/A - Clinical evidence was not necessary to show substantial equivalence."
Therefore, I cannot provide a table of acceptance criteria and reported device performance tailored to the metrics typically found in efficacy studies (e.g., sensitivity, specificity, AUC), nor can I detail the specifics of a study proving those criteria, as such a study is not described in the provided text.
Based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Type Described in Document | Reported Device Performance |
|---|---|
| System level verification | Successfully met |
| User interface verification | Successfully met |
| Usability validation | Successfully met |
| Substantial equivalence to predicate devices | Achieved |
Explanation: The document indicates that substantial equivalence was shown because the device successfully underwent "system level verification, user interface verification and usability validation." It does not provide specific quantitative performance metrics for these verifications.
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified in the provided document.
- Data Provenance: Not specified in the provided document. The testing was non-clinical, implying internal testing and validation rather than clinical data sets.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. Given the non-clinical nature of the evidence, this information is not expected to be present.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not specified. Given the non-clinical nature of the evidence, this information is not expected to be present.
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:
- No. The document explicitly states: "N/A - Clinical evidence was not necessary to show substantial equivalence." This implies no MRMC study or any clinical effectiveness study comparing human readers with and without AI assistance was performed or submitted.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The device is software that routes and displays medical device data, waveforms, and alarms. Its "performance" is primarily related to its ability to accurately route, store, and display this information, and its new features (smart alarms, ADT connectivity, alarm forwarding). The "validation" performed (system, UI, usability) would assess functionality rather than a standalone diagnostic accuracy in the way an AI diagnostic algorithm might be evaluated. The documentation does not describe a standalone algorithm performance study.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical tests (system, UI, usability), the ground truth would typically be defined by engineering specifications, software requirements, and usability standards rather than medical ground truth like pathology or expert consensus. Specific details are not provided.
8. The sample size for the training set:
- Not applicable. This device is an informatics manager and monitoring platform, not a machine learning model that requires a "training set" in the conventional sense for AI diagnostic or predictive tasks.
9. How the ground truth for the training set was established:
* Not applicable, as there is no "training set" for this type of device mentioned.
§ 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).