(194 days)
The Cardio-Pager™ System described in this submission is a paging system that interfaces with Primary Patient Monitoring Systems in order to provide a secondary means of annunciating and displaying patient alarm information to mobile health care providers. This pager is intended to serves as a parallel, redundant mechanism to inform the clinical staff of patient events.
This device is indicated for use in real-time monitoring of routine patient status and alarm events. The Cardio-Pager™ is limited to use by qualified medical professionals who have been trained on the use of the device. It is intended for use only in a hospital environment. The device has been validated for use with the Marquette Unity Network and the Hewlett-Packard Systems CareNet System.
The Cardio-Pager™ System (also referred to as StatView) is a secondary alarm notification system that transmits text and waveform data from patient monitoring devices to a graphical pager worn by a trained professional in a hospital environment. The system monitors the patient monitoring devices for alarm conditions, and responds by transmitting a page that includes text and waveform information from the patient. This system is not intended to be a primary alarm enunciator. The Cardio-Pager™ System alerts and informs the clinician about critical patient alarms without requiring them to be at or near the bedside or central monitors. The system can also provide periodic updates of heart rate and waveform data at intervals established by the caregivers.
The primary components in the Cardio-Pager™ System are the Critical-Server (also referred to as the WT Server) and the Transmission Subsystem. The server is a standard IBM-compatible PC that connects directly to the patient-monitoring network. The Transmission Subsystem consists of the paging transmitter, a standard serial-to-Ethernet converter, and the Cardio-Pager™ receiver units.
Software modules in the Critical-Server acquire patient information from the patient monitoring network, manage the initiation of paging messages, convert the data to proper format for transmission to the paging transmitter, and send the message to the paging transmitter via a LAN. The paging transmitter then sends the page, using standard POCSAG paging protocol. One or more of the Cardio-Pager™ receiver units may receive the page.
Addition of the Cardio-Pager™ System to the patient monitoring computer network does not in any way affect, modify, or interrupt the normal operation of the hospital patient monitoring system.
The provided text describes the Cardio-Pager™ System, a secondary alarm notification system that transmits text and waveform data from patient monitoring devices to a graphical pager. The document details the device's description, intended use, and performance data from testing.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria (e.g., "accuracy must be >95%"). Instead, it describes functional validation tests. The reported device performance is that it met all challenged functional requirements.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Functional Requirements (Overall System) | All functional requirements were challenged and met in testing. |
| Receipt & Transmission of Patient Alarms | Tested and validated. |
| Request, Receipt & Transmission of Scheduled Updates | Tested and validated. |
| Transmission of Text Messages | Tested and validated. |
| Cardio-Pager™ Receipt of Transmitted Alarms | Tested and validated. |
| Cardio-Pager™ Receipt of Scheduled Updates | Tested and validated. |
| Cardio-Pager™ Receipt of Text Messages | Tested and validated. |
| Compatibility with Marquette Unity Network | Validation for use with Marquette Unity Network confirmed through system-level testing. |
| Compatibility with Hewlett-Packard CareNet System | Validation for use with Hewlett-Packard CareNet System confirmed through system-level testing. |
| Communication between Cardio-Pager System™ and PME (various) | All communication requirements between the Cardio-Pager System™ and Marquette or Hewlett-Packard patient monitoring equipment (PME) were challenged by testing with a variety of Marquette and Hewlett-Packard patient monitoring devices, indicating successful communication across different devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify a numerical sample size (e.g., number of alarms, updates, or messages) for the functional tests. It mentions "a variety of Marquette and Hewlett-Packard patient monitoring devices" were used for system-level testing.
- Data Provenance: The testing was conducted internally by Data Critical Corp. (manufacturer). No information is provided about the country of origin of the data, patient data, or whether it was retrospective or prospective, as the testing was focused on device functionality rather than clinical outcomes with actual patient data. It appears to be prospective functional testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
The concept of "ground truth" as typically applied to AI/diagnostic devices (e.g., expert consensus on medical images) does not directly apply to this functional validation. The ground truth here is the expected behavior of the system based on its design specifications. The testing was against these predefined functional requirements, not against expert medical diagnoses. Therefore, no medical experts were used to establish "ground truth" for the test set in the traditional sense. The "experts" would be the engineers and QA personnel who designed and verified the system's intended functionality.
4. Adjudication Method for the Test Set
Not applicable in the AI/diagnostic sense. The testing involved verifying if the device performed as designed against its functional specifications. There was no "adjudication" between multiple interpretations of medical data. The outcomes of the tests were pass/fail based on meeting the functional requirements.
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 Cardio-Pager™ System is a paging and notification system, not an AI diagnostic tool that assists human readers in interpreting medical cases. Its purpose is to deliver information, not to interpret it or improve diagnostic accuracy with AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the performance testing described is essentially standalone. The system autonomously performs its functions (acquiring, managing, converting, transmitting data, and displaying on the pager). While it interfaces with patient monitoring devices, the testing focuses on the Cardio-Pager™ System's ability to execute its programmed functions without continuous human intervention during the data transmission process. The "human-in-the-loop" aspect comes from the clinician receiving the page and acting on the information, but the system's performance in delivering that information was tested independently.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The ground truth used was the functional design specifications of the Cardio-Pager™ System. The device was tested to ensure it accurately received, transmitted, and displayed the expected text and waveform data according to its predefined operational logic. This is not medical ground truth (like a pathology report for diagnosing a disease), but rather engineering ground truth (does the system do what it's designed to do?).
8. The Sample Size for the Training Set
Not applicable. The Cardio-Pager™ System is not an AI/machine learning device that requires a training set. It is a predefined software and hardware system operating based on fixed algorithms and protocols.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of 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).