(168 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.
CIC Pro Clinical Information Center 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 monitors and telemetry systems can be displayed and printed from the CIC Pro Clinical Information Center central station. Beat to beat patient information for all parameters and waveforms from the bedside and telemetry systems can be displayed.
The CIC Pro Clinical Information Center central station supports the ability to access information from the CIC Pro Clinical Information Center central stations' products in a web browser format. Additionally, the CIC Pro Clinical Information Center central station supports the ability to access patient information collected from the unity network and stored on a network server.
The CIC Pro Clinical Information Center is based on a standard PC platform and provides centralized monitoring of all patients connected to GE Medical Systems Information Technologies (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 provided text does not contain specific acceptance criteria or a detailed study proving the device meets acceptance criteria in the format requested. The document is a 510(k) summary for the CIC Pro Clinical Information Center, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance metrics against pre-defined acceptance criteria.
The "Test Summary" section broadly mentions various quality assurance measures applied to the development of the system, including risk analysis, requirements reviews, design reviews, and different levels of testing (unit, integration, final acceptance, performance, safety). It concludes that these measures demonstrated the device is "as safe, as effective, and performs as well as the predicate device." However, it does not provide:
- A table of acceptance criteria and reported device performance: No specific performance metrics (e.g., accuracy, sensitivity, specificity, or response times for displaying data) are presented alongside acceptance criteria.
- Sample size, data provenance, number of experts, adjudication method, MRMC study, standalone performance, or ground truth details for any test set: These details are entirely absent from the provided text. The document is a regulatory submission summary, not a detailed technical study report.
- Training set sample size or how its ground truth was established: Similar to the test set, no information about training data is provided as the focus is on validation against the predicate.
In summary, based only on the provided text:
- Acceptance Criteria and Reported Device Performance: Not explicitly stated in a quantifiable manner. The general acceptance criterion is that the device is "as safe, as effective, and performs as well as the predicate device."
- Sample size used for the test set and data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and their qualifications: Not mentioned.
- Adjudication method for the test set: Not mentioned.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned.
- Standalone (i.e. algorithm only without human-in-the-loop performance) study: Not mentioned.
- Type of ground truth used: Not mentioned.
- Sample size for the training set: Not mentioned.
- How the ground truth for the training set was established: Not mentioned.
The document primarily relies on demonstrating compliance with voluntary standards and various software development lifecycle testing phases to assert equivalence to a predicate device (K053356: CIC Pro Clinical Information Center).
§ 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.