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Spacelabs Healthcare patient monitors, functioning as either bedside or central monitors; passively display data generated by Spacelabs Healthcare parameter modules, Flexports interfaces, and other SDLC based products in the form of waveform and numeric displays, trends and alarms. Key monitored parameters available on the model 91367, 91369, 91370 and 91387, when employing the Spacelabs Command Module, consist of ECG, respiration, invasive and noninvasive blood pressure, SpO2, temperature and cardiac output. Additional parameters and interfaces to other systems are also available depending on the parameter modules employed.

Spacelabs Healthcare patient monitors are intended to alert the user to alarm conditions that are reported by Spacelabs Healthcare parameter modules and/or other physiologic monitors via Flexport interfaces. These determine a) when an alarm condition is violated; b) the alarm priority (i.e. high, medium or low); c) alarm limits; and d) when to initiate and terminate alarm notifications. The patient monitors are also capable of displaying alarm conditions on other monitors that are on the network through the Alarm Watch feature.

Spacelabs Healthcare patient monitors may also function as a generic display or computer terminal. As a generic display or terminal, the patient monitors allow networkbased applications to open windows and display information on other networked monitors.

Spacelabs Healthcare patient monitors are also designed to communicate with a variety of external devices such as displays, network devices, serial devices, user input devices, audio systems, and local/remote recorders.

Spacelabs Healthcare patient monitors are intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a hospital environment.

The Spacelabs Medical Patient Monitors are a component of the Spacelabs Medical Patient Monitoring System. The four (4) monitor models 91367, 91369 and 91370 and the stationary monitor model 91387; are all similar in that they are all employ the same software and all accept inputs from the family of Spacelabs Parameter Modules. The monitors accept and display parameter information, waveform and numeric data, and alarm conditions including arrhythmia information received from the same family of modules modules.

The portable monitors are capable of operating independent of or connected to the Spacelabs Patient monitoring Network. As independent, portable monitors these devices operate from either AC or battery power. All alarm information received from the parameter modules is visually and audibly available at each monitor. When networked, either physically or wirelessly, these monitors are able to share their information with a central station or with other monitors on the network according to conditions establish by the user/system administrator. They are also able to connect, via the healthcare institution's network, through Dynamic Network Access (DNA) to other applications available on the network.

The stationary monitor, model 91387, can be configured at installation as either a bedside or central station. As an independent bedside monitor the device operates from AC and. presents waveform, numeric data, and alarm conditions, including arrhythmia information, received from parameter modules. When physically networked these monitors are able to share their information with a central station or with other monitors on the network according to conditions establish by the user/system administrator. They are also able to connect, via the healthcare institution's network, through Dynamic Network Access (DNA) to other applications available on the newt6work.

The model 91387 central station monitor provides full monitoring control of remote parameters, including displays and alarms with both visual and audible annunciation for up to 16 patients. All waveform and current numeric data, arrhythmia, ST segment, and trends are available are available at the central station.

The provided text describes the Spacelabs Patient Monitors (models 91367, 91369, 91370, and 91387) and their substantial equivalence to predicate devices. However, it does not contain specific acceptance criteria or a detailed study report with performance metrics in the format usually associated with a medical device's performance evaluation against predefined criteria.

Instead, the document states that the devices were validated through "rigorous testing" to ensure compliance with standards and accurate presentation of parameter data, but it does not quantify this performance or present it in a table of acceptance criteria vs. reported performance.

Therefore, for aspects like "Table of acceptance criteria and reported device performance," "Sample sized used for the test set," etc., the information is not present in the provided text.

Here's an analysis based on the information available in the text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified. The document mentions "test programs" but does not give the number of cases, patients, or data points used.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified.

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

• Was an MRMC study done? No. The document describes patient monitors that display data from other modules and communicate alarm conditions. It does not involve human readers interpreting data that could be assisted by AI.
• Effect size of human readers with vs. without AI assistance: Not applicable, as no MRMC study or AI assistance is mentioned in this context.

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

• Was a standalone study done? The device itself (the monitor) is not an "algorithm" in the sense of making diagnostic interpretations. It's a display and communication device for physiological parameters. The "rigorous testing" mentioned was for the monitor's ability to accurately present data and interface. This aligns more with functional and system integration testing rather than an AI algorithm's standalone performance. No specific standalone performance metrics for an algorithm are provided.

7. Type of Ground Truth Used

• Type of Ground Truth: Not explicitly stated for specific performance metrics. The phrasing "parameter data provided by parameter modules...could be accurately presented" suggests that the ground truth for "accuracy" would be the direct output from the source parameter modules or a reference standard for those parameters. For clinical workflow, the "ground truth" would be the subjective assessment of meeting user needs.

8. Sample Size for the Training Set

• Sample Size: Not applicable. This device is a patient monitor displaying data, not an AI/ML algorithm that is "trained" on a dataset.

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

• How Ground Truth Established: Not applicable. This device is a patient monitor displaying data, not an AI/ML algorithm that is "trained" on a dataset.

Summary of Device and Study Information:

This 510(k) submission is for patient monitors that display and communicate physiological data and alarms from other external modules. The "study" described is a general validation of the monitors' ability to accurately present data, support clinical workflows, and comply with unspecified software standards. There are no detailed performance metrics, test set sizes, expert qualifications, or AI-related study components typically found in submissions for AI/ML-driven devices. The focus is on the functional equivalence and safety of the monitors as display and communication interfaces.

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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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