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The CNS-9700 Series Nurse Central Station is intended for cardiac and vital signs monitoring for multiple patients. The device will display and record physiological data from individual bedside monitors and /or telemetry receiver/transmitters and mimics an alarm when a measured parameter falls outside a preset limit or when an arrhythmia is detected by the bedside monitor or telemetry unit.

The device is intended for use by medical professionals to provide cardiac and vital signs monitoring for multiple patients, up to 16, within a medical facility. The device will display and record physiological data from individual bedside monitors and telemetry receiver/transmitters and generate an alarm when a measured parameter falls outside a preset limit or when an arrhythmia is detected. Arrhythmia detection and alarm determination are functions of the individual bedside or telemetry channel.

The provided text is a 510(k) summary for the Nihon Kohden CNS-9700 Series Central Nurse Station. It describes the device, its intended use, classification, and substantial equivalence to a predicate device. However, the document does not contain information regarding objective acceptance criteria or detailed study results directly proving the device meets specific performance criteria through clinical or technical studies.

The text mentions general testing for operation and software validation, but no specific performance metrics like sensitivity, specificity, accuracy, or any thresholds for these metrics that would constitute "acceptance criteria." It also does not describe any specific studies with sample sizes, expert involvement, or ground truth establishment.

Therefore, I cannot populate the requested table or answer most of the detailed questions based on the provided input.

Here's a breakdown of what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

• Cannot be provided. The document states: "The device was subject to electromagnetic, environmental, safety and performance testing procedures. These tests verified the operation of the device. Software validation tested the operation of the related functions of acquiring, displaying and recording of all functions of the device. The results confirmed that the device performed within specifications." This is a high-level statement and does not include specific, measurable acceptance criteria or reported performance results (e.g., "accuracy > 95%").

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Cannot be provided. No information on sample sizes for any test sets or data provenance is present.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Cannot be provided. No information regarding expert involvement in establishing ground truth is present.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Cannot be provided. No information on adjudication methods is present.

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

• Cannot be provided. This device is a central monitoring station, not an AI-assisted diagnostic tool for human readers. No MRMC study is mentioned or implied. The device's function is to display and record physiological data and generate alarms based on preset limits or arrhythmia detection by individual bedside monitors/telemetry.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Cannot be provided. While the device itself operates "standalone" in its function, the document does not describe specific "standalone performance studies" with quantifiable metrics typically associated with algorithms (e.g., sensitivity, specificity of arrhythmia detection). It only states "Software validation tested the operation of the related functions... The results confirmed that the device performed within specifications." The arrhythmia detection logic is stated to be a function of the bedside or telemetry channel, not necessarily the central station's primary algorithmic function for evaluation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Cannot be provided. No information about the type of ground truth is mentioned.

8. The sample size for the training set

• Cannot be provided. No information on training sets is present. This device is not described as utilizing a machine learning algorithm that requires a "training set" in the typical sense.

9. How the ground truth for the training set was established

• Cannot be provided. (See point 8).

Summary of what the document DOES state regarding testing and performance:

• Testing types: Electromagnetic, environmental, safety, and performance testing procedures. Software validation.
• Purpose of testing: Verified the operation of the device. Confirmed that the device performed within specifications.
• Key finding: The device is substantially equivalent to the Nihon Kohden CNS-9300 series.

This regulatory document focuses on substantial equivalence to a predicate device and general compliance with safety and operational requirements, rather than providing detailed performance data from a specific study against objective acceptance criteria for advanced functionalities like a diagnostic algorithm.

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