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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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The Surveyor Telemetry Central Station is designed to monitor up to 24 adult patients during cardiovascular problematic situations, through ambulatory transmitter sources. When used as a Telemetry Central Station System, Surveyor Central is designed to work with ECG only or multiparemeter transmitters for ECG and SpO2. For each patients ECG waveforms, HR, ST values and other parameters (if available) will be displayed.

The Mortara Surveyor Central Telemetry System is intended for centralized ECG monitoring of hospital patients connected to telemetry transmitters such as the Mortara X12 Ambulatory Telemetry Transmitter (K974149), (presently marketed as the X12+), or other compatible telemetry transmitters. Patients are (101-140), (produkt) manoving in a defined area, of a variable size depending on layout and thickness of walls. In order to guarantee a proper signal transmission in each different situation, an antenna network can be installed according to customer needs.

The cardiac data and analysis provided is reviewed, confirmed, and used by trained medical personnel in the diagnosis of patients with various rhythm patterns.

Indications for Use:

The Surveyor Central Telemetry System is indicated for use:

• ECG monitoring of adult patients in Coronary Care Units, Step-Down Units, Emergency . Departments. It is not designed for use in highly invasive environments, such as an operating theatre.
• Centralized ECG monitoring through a telemetry network of adult palients. Continuous analysis is . provided for all connected patients. It is not designed for use in highly invasive environments, such as an operating theatre.
• Evaluation of adult patients with symptoms suggesting arrhythmia. Detected arrhythmias create an . audio-visual alarm according to the alarm profile.
• . Chest Pain Evaluation.
• Evaluation of adult patients with pacemakers. .
• Evaluation of a patient's response after resuming occupational activities (e.g., after . M.I. or cardiac surgery.)
• Evaluation of ECG documenting therapeutic interventions in individual patients or groups of . patients.
• Clinical and epidemiological research studies.

The Surveyor Telemetry Central Station is a diagnostic tool intended to acquire, and provide real time ECG data of patients that require ECG monitoring during cardiovascular problematic situations. The cardiac data provided is reviewed, confirmed, and used by trained medical personnel to assist in the diagnosis of patients with various rhythm patterns.

The Surveyor Telemetry Central Station will be used for centralized ECG monitoring in a telemetry system consisting of three main components: the ambulatory ECG telemetry transmitters (X12 Ambulatory Transmitters), the receivers combined with an antenna network and the Central Station software application running on a PC.

The transmitter is attached to the patient and acquires a continuous 12-lead ECG signal. The signal is A/D converted and digital data is sent to the Central Station using wireless radiofrequency communication.

The antenna network receives the data sent by the transmitters. The network delivers the signal to the receivers installed in the Central Station PC. The receivers decode the data containing the ECG waveforms and status from the transmitters.

The Central Station retrieves the data from the receivers and performs arrhythmia and ST analysis on the signal. The result of the analysis can trigger an audiovisual alarm. The priority of each arrhythmia and ST alarm is defined in the alarm profile.

When used as a Telemetry Central Station, Surveyor Central Station is designed to work with ECG only or multi-parameter transmitters for ECG and SpO2. The Central Station can simultaneously retrieve, display and analyze ECG signals for up to 24 patients.

A single patient can be selected for reviewing data in the single patient view, which includes following displayed and printed data:

• All 12 real-time ECG leads. .
• Current average and reference QRS complex with current ST levels for all leads .
• The Central Station also stores waveforms, measurement data and alarms for 72 hours. The . waveforms can be reviewed and printed

The provided text describes the Mortara Surveyor Telemetry Central Station, its intended use, and its classification, but it does not contain any information about acceptance criteria or specific studies proving device performance against such criteria.

The document is a 510(k) submission, primarily focused on establishing substantial equivalence to predicate devices and detailing the device's characteristics and intended use. It lists applicable standards (IEC 60601-1, ANSI/AAMI EC11-1991, etc.), which set general safety and performance requirements for medical electrical equipment, but it does not report any specific test results or performance metrics that would typically be used to demonstrate compliance with acceptance criteria.

Therefore, for each of your requested points, the information is not available in the provided text:

1. Table of acceptance criteria and the reported device performance

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

• Sample Size: Not specified.
• Data Provenance: Not specified.

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)

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

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

• Adjudication Method: Not specified.

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

• MRMC Study: Not mentioned. The device is a telemetry central station, not an AI-assisted diagnostic tool in the sense of image interpretation.

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

• Standalone Performance Study: Not mentioned or detailed. The document emphasizes that "The cardiac data and analysis provided is reviewed, confirmed, and used by trained medical personnel," indicating a human-in-the-loop system.

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

• Type of Ground Truth: Not specified.

8. The sample size for the training set

• Sample Size: Not specified. No deep learning or AI model specific training is mentioned for which a training set would be defined.

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

• Ground Truth Establishment: Not specified.

In summary: The provided document is a 510(k) summary emphasizing device description, intended use, and substantial equivalence to predicate devices. It does not contain the detailed performance study results or acceptance criteria that would typically be found in a clinical validation report or similar technical documentation. The standards mentioned refer to general safety and performance, not specific performance criteria for the arrhythmia or ST analysis algorithms.

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The device is intended to acquire and transmit electrocardiograph (ECG) data by means of a radio-frequency transmitter worn by individual patients in a hospital or clinical setting to a central monitor where it is received, displayed, stored, and analyzed, with alarms for heart rate, arrhythmia, and ST change.
The device is to be used on ambulatory adult populations where monitoring is prescribed while undergoing exercise rehabilitation.
Multiple central receivers may be used and connected to a local area network.
Specified wireless data entry devices may be connected to the system via a wireless access point and be used as a station for entry of patient session data.
Optional workstation(s) may be connected to the system via a network for entering and viewing patient demographic and rehab session data. The workstation may also be used for tracking patient progress in cardiac rehab and displaying non-real-time waveforms and alarms.
ECG analysis may include 12-lead ECG interpretation.
Patient demographics, exercise prescription, scheduling information, and collected data can be ported to an outcomes management program.

The Q-Tel RMS telemetry system measures the electrical activity of a patient's heart during an exercise class and transmits it via radio frequency to a central monitoring station. The core features of the O-Tel RMS system include telemetry monitoring, ECG displays, full disclosure of vital signs, printing and reporting, and rehabilitation program management, such as scheduling classes and seminars and patient enrollment.

The monitoring station displays the patient's real-time ECG waveforms and uses programmable alarms to indicate the presence of pre-selected medical or technical conditions, such as arrhythmia or loss of signal. When alerted by the alarm, the clinician determines whether the event causing the alarm is clinically significant or benign. The Q-Tel RMS system enables the clinician to view, edit, record ECG strips, and use a printer to print reports.

Optional workstation(s) may be connected to the Q-Tel RMS via a network for the purpose of entering and viewing patient demographic and session data, which is stored on the Q-Tel RMS system. A workstation may also be used for tracking patient progress in cardiac rehab and displaying non-real-time waveforms and alarms. Workstation(s) may be supplied as a turnkey device or as software only to be installed on specified hardware platform supplied by the customer. The software only workstation provides the same functions as the turnkey workstation except viewing of session data in "read-only" mode.

An optional wireless data entry device, such as a PDA, may act as a station for entry of patient session data which is saved on the Q-Tel RMS system. The wireless entry device has access only to patient session data.

The provided text does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

Instead, the document is a 510(k) summary for a medical device (Q-Tel RMS) seeking substantial equivalence to a previously cleared device. It focuses on comparing the technological characteristics and intended use of the new device with its predicate device to demonstrate that it is equally safe and effective.

Therefore, I cannot provide the requested table or study details based on the input.

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The device is a PC based diagnostic tool intended to acquire, process, and store ECG data of patients undergoing stress exercise testing. The software records ECG, heart rate, and ST data, creates summary tables, trends and a final report regarding a variety of cardiac data indices. The cardiac data provided by X-Scribe II is reviewed, confirmed, and used by trained medical personnel to assist in the diagnosis of the electrocardiographic data reflecting the patient's physiological condition during stress exercise testing.

The device captures and presents electrocardiographic data reflecting a patient's physiological condition during physiologic stress testing that can be useful in determining a diagnosis when reviewed by a trained clinician or physician. The cardiac data provided by X-Scribe II is reviewed, confirmed, and used by trained medical personnel to assist in the diagnosis of adult patients with various rhythm patterns.

The device is not intended to be the sole basis of diagnosis.

The device is indicated for use in a clinical setting by a physician, or trained personnel who are acting on the orders of a licensed physician.

The device is indicated for use on adult populations, typically symptomatic. The device is not intended to be used as a vital signs physiological monitor.

The Mortara X-Scribe II is the latest evolution of the Mortara X-Scribe (K900720). It is a PC based diagnostic tool consisting of an ECG analysis software application running on a commercial PC using Windows operating system. Electrocardiographic data is obtained by means of a compatible device, such as the Mortara X-12 (K974149) or the Mortara direct connect patient cable, and sent to the CPU for processing. The user may generate reports for display or may opt to print results via a printer.

The device consists of a CPU, display, mouse, printer, keyboard, isolation power supply, and data collector. The device may interface with external devices, including a treadmill or erqometer for dynamic exercise evaluation, non-invasive blood pressure equipment, and computer communications equipment.

The provided text describes the Mortara X-Scribe II Stress Exercise Testing System but does not contain specific acceptance criteria or details of a study proving the device meets particular performance metrics. The document is a 510(k) summary and approval letter, which focuses on regulatory clearance based on substantial equivalence to predicate devices, rather than a detailed performance study with acceptance criteria.

Therefore, many of the requested details cannot be extracted from the provided input. However, based on the information that is present, I can provide the following:

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

• This information is not available in the provided text. The document is a 510(k) summary, which typically focuses on describing the device and its intended use, and demonstrating substantial equivalence to a predicate device for regulatory clearance. It does not include a detailed performance study with specific acceptance criteria and reported device performance metrics in the way you might find in an academic paper or a more comprehensive validation report.

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

• This information is not available in the provided text.

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)

• This information is not available in the provided text, as there is no description of a test set or ground truth establishment.

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

• This information is not available in the provided text.

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 information is not available in the provided text. The device is described as an "ECG analysis software application running on a commercial PC," and "The cardiac data provided by X-Scribe II is reviewed, confirmed, and used by trained medical personnel to assist in the diagnosis." This suggests human-in-the-loop operation, but the text does not detail any comparative effectiveness study with or without AI assistance, or any specific AI components that would typically be evaluated in such a study.

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

• This information is not available in the provided text. The "Indications for use" explicitly state, "The cardiac data provided by X-Scribe II is reviewed, confirmed, and used by trained medical personnel to assist in the diagnosis," and "It is not intended as a sole means of diagnosis." This indicates the device is not intended for standalone use without human interpretation.

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

• This information is not available in the provided text, as no performance study or ground truth establishment is described.

8. The sample size for the training set

• This information is not available in the provided text.

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

• This information is not available in the provided text.

In summary, the provided document is a regulatory submission for a medical device (a stress exercise testing system), focusing on showing substantial equivalence to existing devices for market clearance rather than detailing performance studies with specific statistical acceptance criteria. Therefore, the majority of the information requested, which pertains to rigorous performance evaluation and validation, is not present in this type of document.

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