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The CMS network transfers information between HYPERVISOR VI Central Monitoring System and other networked devices. It also allows information transfer between several CMS. Network connections consist of hardwired network cables and/or WLAN connections. CMS can be used for remote monitor management, storing, printing, reviewing or processing of information from networked devices, and it is operated by medical personnel in hospitals or medical institutions.

Telemetry Monitoring System is a sub-system of CMS, intended to obtain ECG and SpO2 physiological information from adult and pediatric patients, and send it to CMS via WMTS frequency within a defined coverage area.

Central Monitoring System network is a kind of medical information system, which consists of different networked devices (which have separate 510(k) clearance). Hypervisor VI Central Monitoring System (CMS) is the primary maintainer of communication between other networked devices. It can store, print, review or process information from networked devices. It can also realize remote monitor management function to free doctors from clinical monitoring work and conduct centralized monitoring management.

In this submission, CMS adds the function of supporting communication with Telemetry Monitoring System. Besides this, CMS is improved to include some new functions, such as, add the function of ViewOtherBed and add the function of real-time print.

By using radiofrequency signal, TMS is intended to monitor Electrocardiogram (ECG), Heart Rate (HR), Arrhythmia Detection, ST Segment Analysis, Saturation of Pulse Oxygen (SpO2) and Pulse Rate (PR) for adult and pediatric patients. Physical signals are collected by sensors and wirelessly transmitted by transmitters in WMTS band, receivers get the signals and forward to CMS for processing, displaying, storing, printing, etc. It can be used within a defined coverage area in hospitals or medical institutions.

CMS is based on the PC platform, and the PC can be configured by users according to the requirements on the operator's manual.

The provided text describes a 510(k) summary for the HYPERVISOR VI Central Monitoring System (including TMS) but does not contain detailed information about acceptance criteria or specific study results that prove the device meets such criteria.

Here's an analysis based on the available information regarding your requested points:

1. Table of Acceptance Criteria and Reported Device Performance

Not available in the provided text. The document states:
"Laboratory testing has been conducted to validate and verify that the CMS (including TMS) meet all design specifications. Results of these tests demonstrate compliance to the requirements of all applied standards."
However, it does not specify what those design specifications or their acceptance criteria were, nor does it present the actual performance results in a table or any other format.

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

Not available in the provided text. There is no mention of a test set, its sample size, or the provenance of any data used for testing.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

Not available in the provided text. There is no information about expert involvement in establishing ground truth.

4. Adjudication Method for the Test Set

Not available in the provided text. No test set details, let alone an adjudication method, are mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable/Not available. The document describes a Central Monitoring System and a Telemetry Monitoring System, which are devices primarily focused on data communication, storage, and display of physiological parameters (ECG, HR, SpO2, PR). These are not AI-assisted interpretative or diagnostic tools for which an MRMC comparative effectiveness study would typically be performed to assess human reader improvement with AI assistance. The text does not mention any AI components or human-in-the-loop assistance features.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not available/Not applicable in the context of an "algorithm only" study as it is understood for diagnostic AI. The device is a monitoring system. The closest equivalent would be performance testing of its internal algorithms for parameter measurement (e.g., arrhythmia detection, ST segment analysis) and communication, but specific details of such studies are not provided beyond the general statement of "Laboratory testing."

7. Type of Ground Truth Used

Not available in the provided text. Given that the device is a monitoring system, ground truth would likely refer to validated reference measurements for ECG, SpO2, heart rate, and arrhythmia detection, but the document does not specify how this was established or what type of ground truth was used.

8. Sample Size for the Training Set

Not applicable/Not available. This device is a monitoring and communication system, not a device that typically "learns" from a training set in the way AI/ML algorithms do. Therefore, a training set in that sense is not relevant and not mentioned.

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

Not applicable/Not available, as there is no mention of a training set.

Summary of what is available regarding testing:

The 510(k) summary broadly states:

• "Laboratory testing has been conducted to validate and verify that the CMS (including TMS) meet all design specifications."
• "Results of these tests demonstrate compliance to the requirements of all applied standards."

However, it does not provide:

• Specific acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds).
• Detailed study protocols or methodologies.
• Actual performance values (e.g., "The device achieved X sensitivity and Y specificity").
• Information on data sets used (sample size, provenance).
• Details about expert review or ground truth establishment.

The focus of this 510(k) appears to be primarily on establishing substantial equivalence to predicate devices based on technological characteristics and software modifications, rather than presenting detailed clinical performance data from a specific study against predefined acceptance criteria for a diagnostic/interpretive algorithm.

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