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The CIC Pro Clinical Information 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 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 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 CIC Pro Clinical Information Center Central Station' products in a web browser format. Additionally, 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 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.

Here's an analysis of the provided text regarding the acceptance criteria and study for the device K053356.

It's important to note that the provided 510(k) summary is for a "Central Station Monitoring System," and the "acceptance criteria" and "study" described are centered around software and system validation, not clinical performance metrics typical of AI/ML devices. This document does not describe the kind of performance study you'd expect for an AI diagnostic tool.

Acceptance Criteria and Device Performance for K053356: CIC Pro Clinical Information Center Central Station

1. Table of Acceptance Criteria and Reported Device Performance

• Code inspections were applied.
• Software and hardware testing was applied.
• Safety testing was applied.
• Environmental testing was applied.
• Final validation was applied. |
  | Overall Equivalence | Demonstrated to be as safe, as effective, and performs as well as the predicate device. |

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a "test set" in the context of patient data or clinical cases. The "testing" mentioned refers to software and hardware testing, safety testing, and environmental testing of the device itself. Therefore, information about sample size for a test set of patient data, data provenance (country of origin, retrospective/prospective), or ground truth is not applicable in the clinical sense for this submission. The validation is focused on system functionality and regulatory compliance.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable as the submission does not describe a clinical performance study using patient data and expert ground truth establishment.

4. Adjudication Method for the Test Set

This information is not applicable as the submission does not describe a clinical performance study requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for AI or diagnostic imaging devices to evaluate human performance with and without AI assistance. The CIC Pro is a central monitoring station, not a diagnostic AI tool, and its submission focuses on system functionality and equivalence to a predicate device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

This concept is not applicable in the context of this device. The CIC Pro is a display and monitoring system that processes and presents existing physiological data. It does not embody an "algorithm" in the sense of a standalone diagnostic or interpretive AI. Its performance is evaluated on its ability to correctly collect, display, and print data as per its intended use and compliance with standards.

7. The Type of Ground Truth Used

The "ground truth" for this device's validation is primarily defined by:

• Predicate Device Performance: The primary "ground truth" or benchmark is the performance of the legally marketed predicate device (K032370 Clinical Information Center (CIC) Central Station). The new device aims to be "as safe, as effective, and performs as well as" the predicate.
• Requirements Specifications: The device's performance is measured against detailed requirements specifications for its hardware and software functions.
• Voluntary Standards: Compliance with relevant industry and regulatory voluntary standards (detailed in Section 9, though not provided in this extract).

There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for a clinical efficacy study.

8. The Sample Size for the Training Set

This information is not applicable. The CIC Pro is a non-AI/ML medical device submission. It does not describe a "training set" in the context of machine learning model development. The development process involved "requirements specification review," "code inspections," "software and hardware testing," etc., but not data-driven machine learning training.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no mention of a training set or machine learning model development. The ground truth for the device's development and validation relied on engineering specifications, regulatory standards, and comparison to the predicate device.

Summary of the Study Performed (as per provided text):

The "study" described for the K053356 CIC Pro Central Station is primarily a System Validation and Equivalence Study. It focuses on demonstrating that the new device shares the "same functional technology" as its predicate device and that its development followed established quality assurance measures.

The study included:

• Compliance Verification: Ensuring the device and its applications comply with relevant voluntary standards.
• Quality Assurance Process Implementation: Application of standard software and hardware development quality measures, including:
  • Requirements specification review
  • Code inspections
  • Software and hardware testing
  • Safety testing
  • Environmental testing
  • Final validation
• Predicate Device Comparison: The ultimate conclusion of the study was that these measurements "demonstrated that the CIC Pro Central Station is as safe, as effective, and performs as well as the predicate device."

This type of submission emphasizes engineering validation and regulatory compliance rather than clinical performance metrics from a patient-data study typical of diagnostic or AI-driven devices.

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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.

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