(153 days)
The Vital Sync™ System is intended for the display and recording of multiple physiological parameters of adult, pediatric and neonatal patients. It is not intended for alarm notification, nor is it intended to control any of the independent bedside devices it is connected to.
The Vital Sync™ System displayed parameters are listed on the following pages.
WARNING: The Vital Sync™ System is not an active patient monitoring system. It is intended to supplement and not to replace any part of the hospital's device monitoring.
The Vital Sync™ System is being extended to offer additional device compatibility and parameter display.
The design features of the subject Vital Sync™ System are substantially equivalent to the design features of the predicate Vital Sync™ system.
Below is an analysis of the provided text regarding the Vital Sync™ System, Model 5000:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated Purpose of Testing) | Reported Device Performance |
|---|---|
| Data collected from bedside devices is not corrupted. | "The results of the tests show that the subject Vital Sync™ System is substantially equivalent to the legally marketed predicate Vital Sync™ System." (Implies data integrity was maintained) |
| Data collected from bedside devices is shown accurately on the subject device. | "The results of the tests show that the subject Vital Sync™ System is substantially equivalent to the legally marketed predicate Vital Sync™ System." (Implies accurate display of data) |
| Device is substantially equivalent to the predicate device (Vital Sync™ System K093244). | "Substantial equivalence was shown through driver validation and regression testing." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" in terms of patient data or clinical samples. The testing described is focused on the device's technical functionality, specifically "driver validation and regression testing." The provenance of any data used for these technical tests is not mentioned (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The ground truth for this device's performance was established through technical validation and regression testing against the predicate device's expected behavior, not through expert review of patient data.
4. Adjudication Method for the Test Set
Not applicable. There was no adjudication method described as the testing was technical validation and regression testing, not a clinical study requiring expert consensus.
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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is a physiological parameter display and recording system, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, in a sense, a standalone performance assessment was conducted for the device's core functionality. The "driver validation and regression testing" evaluated the device's ability to accurately receive and display data from compatible bedside devices. This testing would have assessed the algorithm's performance in managing and presenting data, independent of human interpretation of the displayed parameters.
7. The Type of Ground Truth Used
The ground truth used was the expected and validated behavior of the predicate Vital Sync™ System. The new device's performance in terms of data integrity and accurate display was compared against this established baseline. This is a form of technical validation against a known, established standard (the predicate device's functionality).
8. The Sample Size for the Training Set
Not applicable. The document describes a medical device clearance process for an update to an existing system, not the development of a machine learning or AI algorithm that would require a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there was no training set mentioned or implied for this device.
§ 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).