The CARESCAPE Central Station is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use is to provide clinicians with adult, pediatric and neonatal patient data within a hospital or clinical environment.
The CARESCAPE Central Station is intended to collect, display and print information from a network, including patient demographics, physiological parameters and waveforms, alarm annunciation and/or other non-medical information from monitors and telemetry systems. Physiological parameters and waveforms include electrocardiograph (ECG), pulse oximetry (SPO2), invasive blood pressures (IBP), non-invasive blood pressure (NIBP), respiration (RR), ventilator (VNT), carbon dioxide (CO2), oxygen (O2), mass spectrometry (Gas), temperature (Temp) and bispectral index (BIS). Beat to beat patient information for parameters and waveforms from the bedside and telemetry systems can be displayed. Patient monitor and telemetry system settings can be adjusted. Parameter values derived from patient data can be calculated, displayed, and printed.
The CARESCAPE Central Station supports the ability to access information from GE products and hospital intranet in a web browser format. Additionally, CARESCAPE Central Station supports the ability to access patient information collected from the CARESCAPE network and stored on a network server.
The CARESCAPE Central Station (CSCS) is based on a PC technology platform and is user friendly for easy operation using a simple logical screen menu. The interactive controls include the use of a computer mouse and keyboard and optional touch screen. Optional writers for the purpose of graphing waveforms and printing patient information include a 2-inch Direct Digital Writer and/or a laser printer. Internal and external speakers provide alarm audio indication.
The CSCS provides centralized monitoring of patients connected to GE Medical Systems Information Technologies' monitors and telemetry transmitters. It may be configured to display up to four real-time waveforms per patient for up to 16 patients and up to 9 waveforms for a single selected patient. Waveforms include ECG, SPO2, respiration ventilation flow and pressure, invasive blood pressure and CO2.
Patients may be admitted to and discharged from monitors and telemetry devices from the central location. The central station is also the control and display device for telemetry monitoring. Patient demographic information, including medical record number and patient name made be entered and modified.
The display window for each patient shows waveforms and vital information including: patient name, bed number, arrhythmia and alarm visual indicators, system messages, audio pause indicator, audio alarm indicator, alarm message line, heart rate, PVC count, transmitter number, ECG lead label, pacemaker status, ST measurement, and graph status. Physiological parameters and waveforms from the GE Medical Systems Information Technologies' monitors can be displayed and printed from the CSCS.
Non-real time patient information available for reviewing and printing includes: Graphic Trends, Tabular Numeric Vital SignsTrends, Event HistoryReview, Full Disclosure, Calipers, and ST Review. Data can be printed to a networked laser printer. In the case of Event Review, data can also be printed to a PDF file.
The CARESCAPE Central Station also provides remote control of patient monitor and telemetry device configuration settings that includes:
- . Admitted patient demographics like name and medical record number;
- . Alarm Settings like high/low limit values and alarm priority levels;
- Printing settings like selection of which waveforms to . print on graphs and the printed output destinations;
- ECG settings like primary lead selection, ST analysis ● on/off and pace maker detection on/off;
- Initiate and terminate combination monitoring where a . bedside patient monitor accepts ECG data from a telemetry transmitter;
- Non-ECG parameter settings like respiration lead ● selection and NBP cuff size selection.
The CSCS provides secondary annunciation of alarms from primary bedside monitoring devices and primary annunciation of alarms from wireless telemetry devices.
The Full Disclosure option provides up to 144 hours of beat-to-beat patient information from the bedside or telemetry system for parameters and waveforms. Full Disclosure also stores resting ECGs from 16 patients once per minute for 144 hours and up to 2000 alarm histories with waveform snippets for each patient. This information can be displayed at the CSCS in detailed and summary mode formats.
Here's a summary of the acceptance criteria and study information for the CARESCAPE Central Station, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| System Functionality | Meets design specifications, including all new or modified features. |
| Voluntary Standards Compliance | Complies with applicable voluntary standards. |
| Risk Analysis | Performed during development. |
| Requirements Reviews | Performed during development. |
| Design Reviews | Performed during development. |
| Unit Level Testing (Module Verification) | Performed during development. |
| Integration Testing (System Verification) | Performed during development. |
| Performance Testing (Verification) | Performed during development. |
| Safety Testing (Verification) | Performed during development. |
| Simulated Use Testing (Validation) | Performed during development. |
| Full Disclosure Storage | Doubled to 144 hours (formerly 72 hours on predicate). |
| Full Disclosure Post-Discharge | Added ability to view and print data for up to 144 hours after patient discharge (formerly unavailable). |
| 12SL (Resting ECG) Collection | Automatic collection and storage of 12SL reports each minute for up to 16 patients, limited to last 144 hours (new feature). |
| Alarm History Storage | Added collection and storage of up to 2000 alarm histories (events) per patient for each admit-discharge episode (new feature). |
Note: The document primarily focuses on non-clinical testing and comparison to predicate devices, rather than explicit numerical acceptance criteria for performance metrics like sensitivity, specificity, or accuracy for a medical AI device.
2. Sample Size for Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated as this was a non-clinical study. The "test set" here refers to the system and its functions during various testing phases (unit, integration, performance, safety, simulated use).
- Data Provenance: Not applicable in the context of clinical data for an AI model. The testing was focused on the device's functionality and compliance with standards.
3. Number of Experts Used to Establish Ground Truth for Test Set and Qualifications
- Number of Experts: Not applicable. The "ground truth" for this device's functionality and compliance was based on design specifications, voluntary standards, and quality assurance processes, rather than expert medical interpretation of data.
- Qualifications of Experts: Not applicable in the context of clinical ground truth. The development and testing would have involved engineers, quality assurance personnel, and regulatory affairs experts.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. This was a non-clinical study focused on device functionality and compliance, not on clinical interpretations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Study Performed? No. The document explicitly states: "The subject of this premarket submission, CARESCAPE Central Station, did not require clinical studies to support substantial equivalence." This type of study would typically be conducted for diagnostic or interpretive AI devices.
- Effect Size of Human Readers Improvement with AI: Not applicable, as no MRMC study was conducted.
6. Standalone (Algorithm Only) Performance Study
- Study Performed? No. The device is a "Central Station" software application running on PC technology to collect, display, and manage patient data and alarms from other medical devices. It is not an algorithm designed for standalone diagnostic or interpretive performance.
7. Type of Ground Truth Used
- Type of Ground Truth: For the non-clinical tests, the "ground truth" was established by the device's design specifications, established engineering principles, and compliance with applicable voluntary standards (e.g., IEC 60601-1-8:2006 for alarm tones).
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. The CARESCAPE Central Station is a software-driven device for data management and display, not a machine learning or AI model that requires a "training set" of data in the conventional sense. The "training" here refers to the software development and testing phases.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment for Training Set: Not applicable. As described above, this device does not use a "training set" in the context of machine learning. The development and verification processes followed standard software engineering and quality assurance practices, ensuring the system met its intended specifications and safety requirements.
§ 870.2450 Medical cathode-ray tube display.
(a)
Identification. A medical cathode-ray tube display is a device designed primarily to display selected biological signals. This device often incorporates special display features unique to a specific biological signal.(b)
Classification. Class II (performance standards).