(12 days)
The CIC Pro Clinical Information Center 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 in a centralized location within a hospital or clinical environment.
The CIC Pro Central Station is intended to collect information from a network and display this data. This data includes physiological, patient demographic and / or other non-medical information.
Physiological parameters and waveforms from GE Medical Systems Information Technologies monitors and telemetry systems can be displayed and printed from the CIC Pro Central Station. Beat to beat patient information for all parameters and waveforms from the bedside and telemetry systems can be displayed.
The CIC Pro Central Station supports the ability to access information from GE Medical Systems Information Technologies' products in a web browser format. Additionally, CIC Pro Central Station supports the ability to access patient information collected from the Unity network and stored on a network server.
The CIC Pro Central Station is based on a standard PC platform and provides centralized monitoring of all patients connected to GEMS IT monitors and telemetry transmitters. It may be configured to display up to four real-time waveforms per patient for up to 16 patients.
Controls include the use of a computer mouse, keyboard and optional touch screen for precise touch control. Optional writers for the purpose of graphing waveforms and printing patient information include a 2" Direct Digital Writer or a laser printer.
The document provided is a 510(k) premarket notification for a medical device called the "CIC Pro Clinical Information Center Central Station". This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel clinical efficacy through extensive studies with acceptance criteria, ground truth, and expert adjudication in the way new AI/ML medical devices often require.
As such, the information requested for a detailed study description with acceptance criteria and performance metrics (especially those involving AI/ML components, ground truth establishment, and multi-reader studies) is not present in this 510(k) summary.
Here's why and what information can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance:
- No specific quantitative acceptance criteria or performance metrics (like sensitivity, specificity, AUC) are stated.
- The overall "acceptance criteria" for this type of submission is demonstrating substantial equivalence to the predicate device in terms of safety and effectiveness.
- The "reported device performance" is essentially that the device "is as safe, as effective, and performs as well as the predicate devices." This is a qualitative statement, not a quantitative one.
2. Sample Size Used for the Test Set and Data Provenance:
- No specific test set or data provenance details are provided. The submission mentions "Software and hardware testing," "Safety testing," and "Environmental testing" as part of quality assurance measures, but does not quantify the data or cases used for these tests. The focus is on the process of testing and validation rather than the statistical results of a clinical trial.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications:
- Not applicable for this type of submission. The device is a central station for displaying patient data, not an AI diagnostic tool requiring expert-established ground truth for its analytical output.
4. Adjudication Method:
- Not applicable. No expert adjudication process is described as there's no diagnostic output being evaluated against a ground truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No MRMC study was done or reported. The submission does not involve human readers interpreting output that would be assisted by AI.
6. Standalone (Algorithm Only) Performance:
- Not applicable. The device is a display and information collection system, not an algorithm providing standalone diagnostic or analytical output.
7. Type of Ground Truth Used:
- Not applicable. There's no "ground truth" in the diagnostic sense for this device. Its function is to accurately display physiological and patient data. The "truth" would be the real-time physiological signals from connected monitors, and the testing would focus on the fidelity and reliability of that display.
8. Sample Size for the Training Set:
- Not applicable. The device does not employ machine learning or AI models that require a training set.
9. How Ground Truth for the Training Set Was Established:
- Not applicable. (See point 8).
Summary of what the document does state regarding "testing" and "performance":
The device's performance, safety, and effectiveness are demonstrated through a suite of quality assurance measures applied during its development:
- Requirements specification review
- Code inspections
- Software and hardware testing
- Safety testing
- Environmental testing
- Final validation
The conclusion derived from these activities is that "The CIC Pro Central Station is as safe, as effective, and performs as well as the predicate devices." The relevant predicate device identified is the "K001112 Clinical Information Center (CIC) Central Station."
In essence, this 510(k) submission establishes equivalence by asserting that the new device utilizes the "same functional technology" as its predicate and has undergone standard development and testing procedures, rather than by presenting a clinical study with detailed performance metrics against a defined ground truth.
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.