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The Surveyor Central Station system is intended for monitoring of physiological waveforms, including cardiac and vital signs, for multiple patients within a medical facility. The system can receive, display and store data from multi-parameter patient monitors and/or telemetry systems. The system can support patient monitoring and telemetry monitoring modes simultaneously. Patient monitors can be the Surveyor S12 and S19 patient monitoring systems (K12356) or other compatible patient monitors. Ambulatory telemetry transmitter sources can be the X12+ (K974149) and T12/T12S (K022618) systems or other compatible telemetry transmitters.

In palient monitoring mode, the patient monitors will provide primary monitonality while the Surveyor Central Station system provides continuous secondary monitoring of patients including alarm reception and management, display and storage of parameters and waveforms including full-disclosure, automatic and ondemand generation of various printed reports using a network-attached printer.

In telemetry monitoring mode, the Surveyor Central Station will provide primary monitoring of patients including display of values and waveforms, alarm generation and management, data storage, patient management and report printing functionality. Patients are monitored through telemetry, when moving in a defined area, of a variable size depending on system layout. In order to provide proper coverage, an antenna network can be installed according to customer needs.

The data and analysis provided by the Surveyor Central Station is reviewed, confirmed, and used by trained medical personnel in the diagnosis of patients with various conditions.

The Mortara Surveyor Central Station is indicated for use:

• In a clinical setting, by qualified medical professionals, properly trained for patient monitoring and use of the system. Continuous analysis is provided for all patients. The personnel must be experienced in cardiovascular problematic situations and emergency procedures or pathologies related to cardiac involvements.
• Centralized monitoring through a network of patients in Coronary Care Units, Intensive Care Units, Ambulatory Care Units (Telemetry Units), Step-Down Units, Operating Rooms, Emergency Departments and Surgical Centers. Evaluation of adult and pediatric patients with symptoms suggesting arrhythmia. Detected arrhythmias create an audiovisual alarm according to the alarm profile.
• Chest Pain Evaluation.
• Evaluation of patients with pacemakers.
• Evaluation of a patient's response after resuming occupational activities (e.g., after M.I. or cardiac surgery.)
• Evaluation of monitored parameters documenting therapeutic interventions in individual patients or groups of patients.
• Clinical and epidemiological research studies.

The system architecture of the Surveyor Central Station system is flexible and can be supported on a single workstation computer or multiple workstation computers along with a separate optional storage server. Each workstation can display information for a variable number of patients. Multiple workstations can be combined to expand the system capacity. All data received for all patients is stored and available for review.

Cardiac parameters and functions supported through interface with patient monitors include 3 or 5 lead ECG as well as 12-lead ECG along with interpretation plus continuous monitoring and management of arrhythmia and ST alarms generated by the patient monitor. Cardiac parameters and functions supported through interface with telemetry systems include 12-lead ECG along with interpretation plus continuous monitoring, alaming and management of arrhythmia and ST generated by the Surveyor Central.

Other parameters received from patient monitors or telemetry systems can include invasive pressures, noninvasive blood pressure, pulse oximetry, CO2 capnography, respiration, temperature, cardiac output and hemodynamic calculations including relevant values, indices and waveforms.

This document is primarily a 510(k) summary for the Mortara Surveyor Central Station system, focusing on demonstrating substantial equivalence to predicate devices rather than deeply detailing performance studies with specific acceptance criteria and statistical results for an AI/algorithm.

Based on the provided text, the device in question, the Mortara Surveyor Central Station, is a physiological patient monitor and central station system. It is not an AI-driven device or an algorithm in itself, but rather a system that receives and displays data from patient monitors and telemetry systems, including cardiac parameters and arrhythmia/ST alarms that may involve interpretation by other connected devices.

Therefore, the requested information regarding AI/algorithm performance (e.g., sample sizes for test/training sets, number of experts for ground truth, MRMC studies, standalone performance) is largely not applicable to this specific submission.

Here's a breakdown of what is available and why other details are missing:

Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

1. A table of acceptance criteria and the reported device performance:

The document states:

• "Software for the Mortara Surveyor Central Station was designed and developed according to a robust software development process, and was rigorously verified and validated. Test results indicated that the Mortara Surveyor Central Station complies with its predetermined specification."
• "The Mortara Surveyor Central Station was tested in accordance with internal requirements and procedures, and test results indicated that the device complies with the predetermined requirements. This testing includes performance and functional."
• "The Mortara Surveyor Central Station was evaluated for patient safety in accordance with applicable Standards."
• "The Mortara Surveyor Central Station was tested for EMC in accordance with applicable Standards. Test results indicated that the Mortara Surveyor Central Station complies with its predetermined specification."

Acceptance Criteria & Performance Table (Based on provided text):

Missing Information: The document does not provide specific quantitative acceptance criteria (e.g., specific alarm accuracy percentages, display refresh rates, data throughput) or the numerical results from these tests. It only states that the device "complies" or "was evaluated in accordance with."

The following points are mostly not applicable to this 510(k) submission, as it concerns a central monitoring station for displaying data from other devices, not an independent AI/algorithmic diagnostic tool.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Not applicable / Not specified for an AI algorithm. The testing mentioned (software, functional, electrical safety, EMC) is bench testing of the system itself, not performance evaluation against a clinical dataset for an AI model.
• The document states: "Performance Testing - Clinical: Clinical performance testing was not performed and is not necessary to demonstrate safety and effectiveness of the Mortara Surveyor Central Station."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• Not applicable. No ground truth from expert consensus or clinical data was established for the central station system's performance in this submission, as there was no clinical performance testing the central station's diagnostic capabilities. The system displays interpretations from other devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable. No clinical test set requiring adjudication was used for the central station in this 510(k).

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:

• No. An MRMC study was not done. The device is a central station for displaying data, not an AI assistant intended to improve human reader performance.

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

• Not applicable. This device is a central station system, not a standalone algorithm. While it performs functions like alarm management, its primary role highlighted in this document is receiving, displaying, and storing data from other patient monitors/telemetry systems. The statement "The patients monitors will provide primary monitorality while the Surveyor Central Station system provides continuous secondary monitoring" (in patient monitoring mode) further reinforces this. In telemetry mode, it does provide primary monitoring, alarm generation, and data storage, but the functions are related to the system's own components and data handling, not a diagnostic algorithm.

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

• Not applicable. No clinical ground truth was established or used for the performance evaluation of the central station in this 510(k). The system relies on data and interpretations generated by the connected patient monitors and telemetry systems.

8. The sample size for the training set:

• Not applicable. This device is not an AI/ML algorithm that requires a training set in the conventional sense. Its software development followed a "robust software development process" which implies standard software engineering verification and validation, not machine learning training.

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

• Not applicable. As there is no training set for an AI/ML algorithm for this central station, no ground truth needed to be established for it.

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