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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.

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:

1. 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.
2. 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.
3. 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).

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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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