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510(k) Data Aggregation
(144 days)
MONITORING STATION, CONNEX(R) CENTRAL STATION (CS)
The Connex Central Station (CS) is intended to be used by clinicians for the central monitoring of neonatal, pediatric, and adult patients in health care facilities. In addition to the central monitoring of patient data and alarms, the Connex software can include optional modules to provide extended recording of patient data, including full disclosure.
Connex Central Station, also known as Monitoring Station, is a Windows-based product that provides clinicians with a means to remotely monitor the health of several patients simultaneously. The Monitoring Station receives patient vital signs and alarm data from patient monitors and spot check devices over a network, then displays the data and sounds audio alarms in a centralized location.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Welch Allyn Monitoring Station (Connex Central Station), K132807.
Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It primarily details non-clinical verification and validation testing, rather than a traditional clinical study with defined acceptance criteria and detailed performance metrics as one might see for a diagnostic AI device. Therefore, some of the requested information (like specific performance metrics, sample sizes for test/training sets with provenance, expert qualifications for ground truth, adjudication methods, MRMC studies, or standalone performance) is not explicitly present or isn't applicable in the context of this type of submission for a patient monitoring central station.
1. Table of Acceptance Criteria and Reported Device Performance
For each "Test Objective" below, the implicit acceptance criteria is that the test objective is met and the explicit reported performance is "Pass".
| Test Description or Feature | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Alarm Gateway Settings - Single Central Station | Alarm notifications are properly sent to the 3rd party notification system based on module enablement and configured alarm priorities. | Pass |
| Alarm Gateway Settings - Multiple Central Stations | Alarm priorities can be configured for each central station's alarm notification module; notifications are properly sent based on enablement and configured priorities. | Pass |
| Disconnection with 3rd Party System - Single Central Station | Alarms are displayed on the 3rd party system on (re)connection; disconnection event is logged. | Pass |
| Disconnection with 3rd Party System - Multiple Central Stations | Alarms are displayed on the 3rd party system on (re)connection; disconnection event is logged. | Pass |
| Physiological and Technical Alarms - Single Central Station | Physiological and technical alarms from patient monitors and the monitoring station are delivered to the 3rd party system. | Pass |
| Alarm Logging, Acknowledgment, and Response - Single Central Station | Alarm notification messages are logged with a timestamp; acknowledgment of receipt by the 3rd party system is logged; responses from the 3rd party system are logged. | Pass |
| AGS Outbound Licensing | Alarm notifications are sent when valid software licenses for the 3rd party module are available and not sent otherwise; notifications are sent after license activation. | Pass |
| AGS Performance - Single Central Station | An alarm from an initiating source is delivered to the 3rd party notification system within 8 seconds. | Pass |
| Early Sense Settings | Early Sense patient monitor module settings cannot be changed from the monitoring station; changes made on the patient monitor are displayed on the monitoring station. | Pass |
| Early Sense Patient Turning | Patient turn timer and completed turns sent from the patient monitor are received and displayed correctly. | Pass |
| Early Sense Sources | Monitoring Station displays parameter sources correctly for Early Sense sensors. | Pass |
| Early Sense Exit and Motion Alarms | Early Sense Exit and Motion alarms and values display correctly on Monitoring Station. | Pass |
| Early Sense Functionality Multiple Devices | Early Sense functionality is verified when using multiple patient monitors. | Pass |
| Early Sense Technical Alarms | Early Sense technical alarms display correctly on Monitoring Station. | Pass |
| HL7 - Configuration Settings | Monitoring Station allows HL7 settings (including parameters exported and version) to be configured. | Pass |
| Repeater Display Visual Duplications | Repeater Display is a visual duplication of the Central Station display. | Pass |
| Visual and Audible Duplications of Alarms | Repeater Display provides visual and audible duplication of the Monitoring Station display. | Pass |
| Graphical Trends - Parameters | Monitoring Station can display and graphically trend parameters. | Pass |
| Graphical Trends Display Options and Navigation | Monitor Station can display and graphically trend parameters (implies proper display/navigation functionality). | Pass |
| Graphical Trends Review Report | Printing of Graphical Trends Review report is verified. | Pass |
| Patient Review and 1 day Full disclosure licensing (Functionality 1) | Application allows reviewing the last 24 hours of vitals data on Flow sheet, Graphical trends, and Continuous trends view when licenses are activated. | Pass |
| Patient Review and 1 day Full disclosure licensing (Functionality 2) | Review functionalities are available when Full disclosure, Continuous Trends, Graphical Trends, and Flow Sheet view licenses are configured. | Pass |
| Connex Central Station and CVSM 6000 Series Patient Monitor, with Early Sense, Directions for Use Summative Validation | Directions For Use meet usability requirements as defined in Usability Specifications. | Pass |
| Connex Central Station and CVSM 6000 Series Patient Monitor, with Early Sense, Summative Validation | Product meets usability requirements with trained end-users and satisfies user needs. | Pass |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified in terms of number of patients or specific data points. The testing describes functional, performance, and usability tests on the device and its various new features.
- Data Provenance: The document does not mention specific clinical data or patient data being used for these non-clinical tests. It implies simulated environments or direct device-to-device communication for testing functionalities like alarm delivery or data display. The tests are "Non-Clinical Tests."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable. The "ground truth" for these tests relates to the expected functional behavior of the software and hardware according to design specifications and standards.
- Qualifications of Experts: Not applicable. These were verification and validation tests against pre-defined specifications rather than expert interpretation of clinical data.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The tests are pass/fail based on whether the system performs as expected, not on subjective interpretations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was it done? No. The document explicitly states: "No clinical studies were utilized for the purpose of obtaining safety or effectiveness data." This submission is for a central monitoring station, not a diagnostic AI device requiring MRMC studies.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Was it done? In a sense, yes, for specific functionalities. The tests described are primarily standalone device performance tests, verifying the software and hardware functions as designed, independent of human interaction within the test (though human users were involved in usability testing). However, this is not a "standalone algorithm" in the context of typical AI device evaluation. The device itself is designed for human-in-the-loop operation by clinicians.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth for these non-clinical tests is established by the device's design specifications, relevant industry standards (IEC, ISO), and functional requirements for the software and hardware features. For usability testing, it would be adherence to pre-defined usability requirements.
8. Sample Size for the Training Set
- Sample Size: Not applicable. This is a traditional software/hardware medical device, not an AI/ML device that requires a training set in the typical sense.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment: Not applicable, as there is no "training set." The device's functionality is based on deterministic programming and hardware design, not machine learning from a data set.
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