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The indications for use of the VitalCom Networked Monitoring™ system (VCOM, IRVS/RVS) are:

Monitoring of Recognized Conditions

An environmentally controlled clinical settings that has multiple patients using any combination of ECG leads, bedside monitors or Nellcor Puritan Bennett (NPB) 7200 series ventilators.

Hospital areas that have the capability of installing hardwire paths to the VitalCom's Central Monitoring Station (VCOM) from the rooms or areas where bedside monitors or NPB 7200 series ventilators operate.

Clinical areas that have the capability of installing 174-216 MHz radio systems (or alternate frequency bands approved by the FCC) to communicate via RF. The information from the ECG leads, bedside monitors or NPB 7200 series ventilators is transferred via an RF transmitter to the Central Monitoring Station (VCOM),

The Target Population

Those patients who are connected through the VitalCom Networked Monitoring™ system via ambulatory ECG transmitters, bedside monitors or NPB 7200 series ventilators.

Important Limitations

Each VitalCom Network Monitoring™ system can monitor up to a maximum of 10 patients per Central Monitoring Station (VCOM) and 200 patients per VitalCom Networked Monitoring™ system.

The VitalCom Central Monitoring Station (VCOM) is to be installed at the point of care locations that have the capability of installing hardwire paths to a VCOM from rooms or areas where bedside monitors or NPB 7200 series ventilators operate.

If employing wide area networking technology, the communication between the VCOM, at the point of care location, and the IRVS/RVS, at the supplementary care location, is facilitated by dedicated telephone lines and commercially available interface hardware.

The VitalCom Networked Monitoring™ system is not for use in the home.

The Central Monitoring Station (VCOM), is only used at the point of care location and is capable of operating independently of any IRVS/RVS connections.

The typical VCOM monitors up to ten patients using either ambulatory ECG transmitters (V-Pak) or radio transmitters (V-Link) connected to bedside monitors or ventilators. The VitalCom Networked Monitoring™ system may include interactive remote viewing stations (IRVS), and remote viewing stations (RVS) or VCOMs linked using the VitalCom wide area network (WAN) technology (Site-Link). As with the predicate device, multiple central stations (VCOM Hubs) maybe used in the clinical setting and connected via a local area network (LAN).

The provided text describes a premarket notification for the VitalCom Networked Monitoring System, focusing on its expansion to include patient monitoring using ventilators. The document primarily discusses substantial equivalence to predicate devices rather than providing detailed acceptance criteria and study results in the typical format for performance studies.

Based on the provided text, a comprehensive table of acceptance criteria and reported device performance, as well as detailed information on sample size for test sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for both test and training sets, cannot be fully extracted and thus can only be partially addressed or inferred.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" with corresponding "reported device performance." Instead, it focuses on demonstrating "substantial equivalence" to predicate devices, particularly the VitalCom MPC 1100 (K942147). The "Expanded Features" column in the "Comparison Matrix" can be interpreted as the target performance/capabilities for the new device, which are largely equivalent to, or an enhancement of, the predicate device.

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

• Sample Size for Test Set: The document mentions a "study conducted between St. Mark's Hospital and Allen Memorial Hospital" for clinical performance data. However, it does not specify the sample size (number of patients or data points) used in this clinical study.
• Data Provenance: The clinical data was "provided in summary format for the study conducted between St. Mark's Hospital and Allen Memorial Hospital."
  • Country of Origin: The hospitals mentioned (St. Mark's Hospital and Allen Memorial Hospital) are typically associated with the United States.
  • Retrospective or Prospective: The document does not explicitly state whether the study was retrospective or prospective. Given the context of expanding intended use and conducting a study for substantial equivalence, it could be either, but prospective collection for new features is more common.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not provide any information regarding the number of experts, their qualifications, or how ground truth was established for the clinical performance data.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method (e.g., 2+1, 3+1, none) for the test set.

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

This document describes a device that is a central monitoring station, transmitters, and arrhythmia/ST segment analysis, with expanded capabilities to integrate with ventilators. It is a system for monitoring and displaying physiological data and alarms. The document does not mention any AI assistance or a MRMC comparative effectiveness study involving human readers. Therefore, there is no information about effect size of human reader improvement with AI assistance.

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

The "Non-Clinical Performance Data Review" section mentions "software verification and validation of both the system software performance as well as the operating system software performance." This generally refers to standalone algorithm testing to ensure it functions as designed. The device's primary function includes automated detection and alarm generation. This can be interpreted as standalone performance for the specific algorithms within the system (e.g., arrhythmia detection, ST segment analysis, and processing of ventilator alarms).

7. The Type of Ground Truth Used

For the technical aspects (EMI, software validation, environmental), the ground truth would be established by engineering specifications, industry standards, and validated testing protocols.

For the clinical performance, the document does not explicitly state the type of ground truth used. Given it's a monitoring system, it typically involves:

• Comparison to existing, validated monitoring devices (predicate devices) for accuracy of physiological parameter display and alarm generation.
• Clinical observation and expert interpretation of patient conditions when correlating with device outputs.

8. The Sample Size for the Training Set

The document does not mention a training set or its sample size. This is likely because the device is not presented as an AI/machine learning product that requires distinct training and test sets in the modern sense. It appears to be an upgrade to an existing system, where performance is validated against established medical device standards and predicate device equivalency.

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

As no training set is mentioned (see point 8), this information is not applicable or provided.

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