(106 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 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.
This 510k is intended to add new features to the existing Vital Sync IM & VPMP:
Additional User Interface Additional Report Auto device Association Area (zone) Management Optional Off the Shelf Software/server
Here's an analysis of the provided text regarding the acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, the device is the Vital Sync™ Informatics Manager & Virtual Patient Monitoring Platform. The document describes a 510(k) submission for new features being added to an existing and legally marketed device. Therefore, the "acceptance criteria" discussed are primarily related to establishing substantial equivalence to the predicate device, rather than explicit performance metrics for a new, first-of-its-kind device.
| Acceptance Criteria | Reported Device Performance (as demonstrated by studies) |
|---|---|
| Safety and Efficacy for new features: To ensure the added features (Additional User Interface, Additional Report, Auto device Association, Area (zone) Management, Optional Off the Shelf Software/server) do not compromise the safety or effectiveness of the device compared to the predicate. | Demonstrated through: |
- System level verification
- User interface verification
- System validation
- Device compatibility verification
(The results of these tests showed that the subject device can be considered substantially equivalent to the legally marketed predicate.) |
| Identical Indications for Use: The new device (with added features) must retain the same intended uses as the predicate device. | The subject device has "identical indications for use" as the predicate device. |
| Does not alter parameters, waveforms, and alarms: The software must only route and display, not modify, the data from connected medical devices. | The device "does not alter the parameters, waveforms, and alarms displayed and does not control any of the medical devices connected." |
| No new questions of safety and effectiveness: The introduction of new features should not raise new concerns beyond those addressed by the predicate. | "No new questions of safety and effectiveness have been raised." |
| Substantial Equivalence: The overall determination that the subject device is as safe and effective as a legally marketed predicate device. | "Substantial equivalence is shown through systems level testing, user interface testing, and system validation." |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify sample sizes for any test sets used in the verification or validation activities. It also does not mention an explicit "test set" in the context of clinical data or patient data. The studies described are primarily non-clinical engineering and software validation tests.
The data provenance is therefore internal to the manufacturer's testing and validation processes. No external or patient-related data provenance (e.g., country of origin, retrospective/prospective) is provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided in the document. The studies mentioned are primarily non-clinical, focusing on system functionality and equivalence, rather than diagnostic accuracy requiring expert ground truth establishment for a test set.
4. Adjudication Method for the Test Set
This information is not provided and is not relevant to the type of non-clinical testing described. Adjudication methods (like 2+1 or 3+1) are typically used in studies involving expert review of clinical cases to establish ground truth, which is not the nature of the studies 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
No, an MRMC comparative effectiveness study was not done. The device is software that routes and displays data; it is not an AI diagnostic tool and does not involve "human readers" in the context of an MRMC study. The document explicitly states: "N/A - Clinical evidence was not necessary to show substantial equivalence."
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
The device is a "Virtual Patient Monitoring Platform" that displays data for "healthcare professionals" to utilize for clinical decisions. Its very nature implies a human-in-the-loop interaction. Therefore, a standalone (algorithm only) performance assessment as typically understood for AI diagnostic algorithms was not done, nor would it be entirely applicable to this device's function. The "algorithm" here is the software's ability to accurately route and display data without alteration. The non-clinical tests (system level verification, user interface verification, system validation, device compatibility verification) confirm this core functionality.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
Given that the studies are non-clinical engineering and software validation:
- The "ground truth" for system level verification would likely be the defined technical specifications and requirements of the software.
- The "ground truth" for user interface verification would be the design specifications and usability requirements.
- The "ground truth" for system validation would be that the system performs as intended and meets its functional requirements in a simulated or controlled environment.
- The "ground truth" for device compatibility verification would be the accurate transmission and display of data from connected predicate or representative medical devices.
No clinical "ground truth" (expert consensus, pathology, outcomes data) was used or needed for this 510(k) submission, as stated, "Clinical evidence was not necessary to show substantial equivalence."
8. The Sample Size for the Training Set
This device is not an AI/machine learning device that requires a "training set." Therefore, this information is not applicable and not provided.
9. How the Ground Truth for the Training Set was Established
As the device does not employ a training set (it's not an AI/ML algorithm), this information is not applicable and not provided.
§ 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).