(48 days)
The Vital Sync™ 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 utilize the hospital's network and existing hardware for installation and display. 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 provided 510(k) summary for the Vital Sync™ Informatics Manager & Virtual Patient Monitoring Platform (K130796) does not describe specific acceptance criteria or a detailed study of device performance with reported metrics.
Here's a breakdown of the information available based on your request:
1. Table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics (e.g., accuracy, sensitivity, specificity). The document refers to "system level verification, user interface verification, system validation, and device compatibility verification" as methods to show safety, efficacy, and substantial equivalence. These are broad categories of testing, not specific performance criteria.
- Reported Device Performance: No quantitative performance metrics are reported. The document states that "The results of the tests show that the subject Vital Sync™ Informatics Manager & Virtual Patient Monitoring Platform is safe and effective and can be considered substantially equivalent to the legally marketed predicate." This is a qualitative conclusion rather than a presentation of data against specific criteria.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified. The document indicates "Non-Clinical Evidence" and states "N/A - Clinical evidence was not necessary to show substantial equivalence." This implies no patient data (clinical data) was used in the evaluation for substantial equivalence, focusing instead on system and usability testing.
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)
- Number of Experts & Qualifications: Not applicable. Since no clinical data or ground truth related to patient conditions was used, no experts were needed for this purpose. The device routes and displays data, it doesn't interpret or diagnose. "Summative usability testing" was mentioned, which would involve users, but details on their number or specific qualifications (beyond "healthcare professionals" as indicated in the Indications for Use) are not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable, as there's no mention of a ground truth established by experts for a test set.
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
- MRMC Study: No, an MRMC comparative effectiveness study was not done. The device is a data routing and display platform, not an AI-powered diagnostic tool that assists human readers. No AI components are mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This device is an "Informatics Manager & Virtual Patient Monitoring Platform" intended for "healthcare professionals" to remotely consult and review data. Its primary function is to route and display, explicitly stating it "does not alter the parameters, waveforms and alarms displayed and does not control any of the medical devices connected." It's an information display system for human use, not an automated algorithm for interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: Not applicable regarding patient conditions or diagnoses. The "ground truth" for this type of device would relate to the accuracy of data transmission, display fidelity, and system functionality. This would be established through engineering verification and validation (e.g., comparing displayed data to source data, ensuring alarms are routed correctly).
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This device does not appear to employ machine learning or AI that would require a training set.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.
In summary, the 510(k) submission for K130796 emphasizes substantial equivalence to a predicate device based on non-clinical testing (system verification, user interface verification, system validation, and device compatibility verification). It does not present detailed quantitative performance metrics, clinical study data, or information regarding AI/ML-driven performance evaluation.
§ 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).