Search Results

The device is intended to monitor, display and record physiological data to provide cardiac and vital signs monitoring within a medical facility. The device is intended to monitor the electrocardiogram to generate audible and/or visible alarms when an arrhythmia exists. The device is also intended to monitor heart rate, pulse rate, blood oxygen saturation (SpO2), noninvasive blood pressure (NIBP), invasive blood pressure (IBP), body temperature, carbon dioxide concentration (CO2 and EtCO2), and respiratory rate. The device may generate an audible and/or visible alarm when a measured rate falls outside preset limits. The device may also condition and transmit physiological signals via radio frequency. This will be available for use by medical personnel on all patient populations.

The CGS-9001A Series Communication Gateway Server is an Optional Accessory to the BSM-2300A and BSM-6000 Bedside Monitors, it is a software product that allows the Nihon Kohden Patient Monitoring System to transfer alarm event information from the monitoring device to a third party system. The Communication Gateway Server collects alarm information from all networked patient monitors in a Nihon Kohden Patient Monitoring System and forwards it to a commercially available third party Secondary Alarm Notification System. The alarm notification generated by the third party alarm (not marketed by Nihon Kohden America, Inc.) is for Secondary Alarm Notification Only.

The provided text describes a 510(k) summary for the Nihon Kohden BSM-2300A and BSM-6000 Bedside Monitors with the CGS-9001A Communication Gateway Server. The document focuses on regulatory approval based on demonstrating substantial equivalence to a predicate device, rather than a clinical study establishing specific performance acceptance criteria for a new clinical indication.

Therefore, many of the requested elements for describing specific acceptance criteria and a study that proves the device meets them cannot be fully extracted from this document, as the submission primarily pertains to the safety and performance verification of a device accessory that facilitates alarm information transfer, not a diagnostic or therapeutic AI algorithm.

However, I can extract the available information and highlight what is not present.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

This information is not explicitly provided. The documentation refers to "safety and performance testing procedures" but does not detail the sample size (e.g., number of patients, number of alarm events tested) for these tests, nor the data provenance (country of origin, retrospective/prospective). Since the device is a communication gateway for alarm events, the testing would likely involve system integration and alarm transmission validation, rather than a clinical dataset in the traditional sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided. Given the nature of the device (a communication gateway accessory), the "ground truth" would likely involve technical validation of alarm transmission and accuracy, rather than clinical consensus by medical experts in diagnosing conditions.

4. Adjudication method for the test set

This information is 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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic or AI-powered algorithms where human interpretation of medical images or data is involved. The CGS-9001A is an accessory to facilitate alarm notification and does not involve AI or direct human interpretation of complex medical data for diagnosis.

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

This is not applicable in the context of an "algorithm only" as found in AI/ML devices. The device's primary function is to collect and forward alarm information. Performance testing would likely focus on the accuracy and reliability of this transmission, which is a standalone function of the accessory. The document states "These tests verified that the device performed within specifications," confirming a form of standalone performance evaluation for its intended function.

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

The document does not explicitly state the type of "ground truth" used. For a communication gateway device, the ground truth would likely refer to the accurate transmission of alarm data as generated by the bedside monitors to a third-party system, verified against the actual alarm events occurring on the monitors. This would involve comparing the transmitted data with the source data rather than an external clinical ground truth like pathology or expert consensus.

8. The sample size for the training set

This information is not applicable and not provided. The CGS-9001A is a software product for alarm communication, not an AI/ML algorithm that requires a training set.

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

This information is not applicable and not provided, as there is no training set for this device.

Ask a specific question about this device