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The CNS-2101 central monitor is a networked multi-patient monitoring system, that is intended to display, record and print monitored physiological data from Nihon Kohden bedside monitors, telemetry receiver and/or transmitters. The CNS-2101 does not perform any data processing on the Nihon Kohden compatible devices. When the CNS-2101 is to connect with the Nihon Kohden bedside monitors and telemetry receivers/transmitters the CNS-2101 can:

• · Admit and discharge patients on the Nihon Kohden network.
• · Display and manage compatible devices' real-time patient clinical data.
• Mimic the alarms of connected devices when a measured parameter falls outside a preset limits or when an arrhythmia is detected.
• · Review and trend data calculated by connected Nihon Kohden devices.
• · Store and transfer historical clinical data for the connected systems.
• · Print patient data.

The CNS-2101 is intended for use in professional medical facilities by trained medical personnel.

The CNS-2101 central monitor is a central monitoring device designed to support medical personnel to provide medical care to multiple patients at the same time. It acquires vital sign data from multiple monitoring devices such as bedside monitors and displays the acquired data such as ECG and pulse rate on the screen as well as informing alarms.

The CNS-2101 can communicate with other devices through a network connection. The CNS-2101 can acquire vital sign data directly from multiple monitoring devices (e.g., bedside monitors) connected to Nihon Kohen Monitoring device network or using multiple patient receivers and transmitters, or by a combination of both methods. The parameters to monitor on the central monitor can be changed as necessary by selecting a monitoring device such as a bedside monitor or transmitter and changing the parameter settings for that device.

The CNS-2101 is designed to be installed in a location outside the patient environment such as a nurse's station for central monitoring.

The provided text is a 510(k) summary for the Nihon Kohden CNS-2101 Central Monitor. This document focuses on demonstrating substantial equivalence to a predicate device through comparison of features and adherence to recognized standards. It does not present specific acceptance criteria with numeric performance values or detailed performance study results in the way typically found for AI/ML-driven devices with diagnostic or prognostic claims.

Therefore, for the information requested:

1. A table of acceptance criteria and the reported device performance: This information is not explicitly provided in the document. The document states that the device was tested according to international and FDA-recognized consensus standards to verify and validate its functionality and technical characteristics. However, specific performance metrics (e.g., sensitivity, specificity, accuracy) are not listed for the CNS-2101.

2. Sample size used for the test set and the data provenance: This information is not provided. The testing described is verification and validation (V&V) against design specifications and consensus standards, not clinical performance testing with patient data in the context of diagnostic accuracy.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not applicable and therefore not provided. "Ground truth" in the context of diagnostic accuracy is not relevant to the described V&V testing of a central monitoring system.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable and therefore not provided.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable and therefore not provided. The CNS-2101 is a central monitoring system that displays data from other devices; it does not utilize AI to assist human readers in interpretation or diagnosis.

6. If a standalone (i.e., algorithm-only without human-in-the-loop performance) was done: Not applicable and therefore not provided. The CNS-2101 is a networked multi-patient monitoring system, not a standalone diagnostic algorithm. It displays data from already cleared bedside monitors and telemetry systems. It "does not perform any data processing on the data received from the Nihon Kohden compatible devices."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable and therefore not provided, as the testing relates to the functional performance and safety of the system rather than diagnostic accuracy against a specific condition.

8. The sample size for the training set: Not applicable and therefore not provided. The document describes a central monitoring system, not an AI/ML device that requires training data.

9. How the ground truth for the training set was established: Not applicable and therefore not provided.

Summary of available information regarding performance:

• Acceptance Criteria: Not explicitly defined with performance metrics like accuracy, sensitivity, or specificity. Instead, the acceptance criteria are implied by adherence to recognized consensus standards for medical electrical equipment, software lifecycle, risk management, usability, electromagnetic compatibility, and alarm systems.
• Study Proving Device Meets Acceptance Criteria: Non-clinical verification and validation testing was conducted on the CNS-2101 based on the following standards and guidance:
  • ISO 14971:2019 Medical devices - Application of risk management to medical devices
  • IEC 62304:2006/A1:2015 Medical device software - Software life cycle processes
  • ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 Medical electrical equipment—Part 1: General requirements for basic safety and essential performance
  • IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
  • IEC 60601-1-8: 2012 Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
  • IEC 60601-2-27:2011 Medical electrical equipment--Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
  • ANSI/AAMI/IEC 62366-1:2015 Medical devices -Part 1: Application of usability engineering to medical devices.
  • Various FDA guidance documents related to software validation, cybersecurity, interoperable medical devices, off-the-shelf software, EMC, and human factors.
• Reported Device Performance: The document states that "All function in the CNS-2101 have been validated by the FDA-recognized consensus standards, therefore, the validity of the results can be ensured." It also notes that "Tests conducted within the software development cycle demonstrate that communication between the CNS-2101 and the Nihon Kohden 510(k)-cleared monitoring devices is robust and stable enough to exchange accurate physiological data in real time."

In essence, the document confirms that the CNS-2101 complies with relevant safety and performance standards for its intended function as a central monitoring system, without requiring a clinical validity study involving comparison to a "ground truth" or expert adjudication for diagnostic accuracy.

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