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The intended use of the Spacelabs Medical Ultraview™ Waveform Pager System is to interface with the Spacelabs monitoring network in order to provide a secondary means of annunciating and displaying patient alarm information to mobile healthcare providers. The device is indicated for use in real-time monitoring of routine patient status and alarm events. The pager is intended to serve as a parallel, redundant mechanism to inform the clinical staff of patient events. The Ultraview™ Waveform Pager System is intended for use as a secondary alarm in any hospital environment currently using or intending to use a Spacelabs patient-monitoring network. The Waveform Paging System supplements the primary patient-monitoring system by providing a forwarding mechanism for annunciating and displaying patient alarm events and the critical information associated with the events - including parameter values and waveforms, typically within 4 - 8 seconds of an alarm event on the patient monitor. The pager provides an audio or vibrating alert along with a series of displays showing patient identification, alarm parameters, and up to a 12-second waveform snapshot.

The Spacelabs Medical Ultraview™ Waveform Pager System is a secondary alarm. It does not replace the primary alarm function on the monitor.

The Spacelabs Medical Ultraview™ Waveform Pager System provides caregivers within a clinical environment the ability to remain mobile and be notified when an alarm event occurs. Typically, alarm notification by the pager occurs within 4-8 seconds of an alarm event on the patient monitor. The pager provides an audio or vibrating alert along with a series of displays showing patient identification, alarm parameters, and up to a 12-second waveform snapshot.

The administration module allows convenient assignment of patients to caregivers from any location on the network, including WinDNA-enabled Universal Clinical Workstations. Patient status updates can also be scheduled for dispatch to the pager on a repeating basis if desired.

This system is not a replacement for the primary alarm notification system. The delivery of pages cannot be guaranteed or verified. The Waveform Paging System is intended to augment alarm notification. It is not intended or designed to replace monitoring personnel, good clinical judgment, or to be used in place of bedside and remote alarm notification, or the Alarm Watch function of the monitor.

The device subject to this submission is Model 91841. Each Spacelabs Medical Ultraview™ Waveform Pager System consists of a Server which collects and formats data from the monitoring network, a Transmitter which broadcasts the information to the mobile caregiver, and a Receiver which receives the broadcast and displays the formatted information.

The provided document, K992749, is a 510(k) Safety and Effectiveness Summary for the Spacelabs Medical Ultraview™ Waveform Pager System. It does not contain detailed information about specific acceptance criteria or an explicit study proving device performance against those criteria in the way a modern clinical validation study would be presented for an AI/ML device.

Instead, it relies on a comparison to predicate devices and general performance claims. Here's a breakdown of the available information based on your requested categories:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't provide a formal table of acceptance criteria with specific quantifiable metrics. However, key performance characteristics are mentioned as a comparison to predicate devices and as functional requirements.

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

The document does not specify a scientific study with a defined test set sample size or data provenance in the way a modern clinical validation for AI/ML would.

Instead, it states: "The Spacelabs Medical Ultraview™ Waveform Pager System will be subject to extensive safety and performance Final testing for the system testing prior to release includes various performance tests designed to ensure that the device meets all of its functional requirements and performance specifications." (Page 2)

This suggests internal engineering and functional testing rather than a clinical study with patients or a specific dataset.

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

Not applicable, as no external "test set" and corresponding "ground truth" established by experts for performance evaluation are described. The testing described is internal and functional.

4. Adjudication method for the test set

Not applicable.

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

Not applicable. The device is a secondary alarm notification system, not an AI-assisted diagnostic tool that would involve human readers interpreting data.

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

The device is a system for relaying information, not an algorithm that performs analysis. Its core function is to transmit data, and its performance would be judged on the speed and accuracy of that transmission, effectively a "standalone" system in terms of its notification function. However, this is not in the context of an AI/ML algorithm.

7. The type of ground truth used

For functional performance related to alarm notification time and data display, the "ground truth" would likely be derived from:

• System logs/measurements: Actual time taken for a page to be sent and received following an alarm event on a patient monitor.
• Visual inspection: Verification that the correct patient ID, alarm parameters, and waveform snapshot are accurately displayed on the pager device.
• Predicate device comparison: Functional equivalence to the legally marketed predicate devices (K973527 Data Critical Corporation's Cardio-Pager System and K971868 Marquette Medical Systems Impact Pager System) formed the primary basis for regulatory clearance.

8. The sample size for the training set

Not applicable. The device is not an AI/ML system that requires a "training set."

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

Not applicable.

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