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.

Device Description

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.

AI/ML Overview

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):

Acceptance Criteria Category	Reported Device Performance
Software Verification & Validation	Complies with predetermined specifications.
Internal Performance & Functional Requirements	Complies with predetermined requirements.
Electrical Safety	Evaluated in accordance with applicable Standards.
Electromagnetic Compatibility (EMC)	Complies with predetermined specifications and applicable Standards.

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.

Summary

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Abbreviated 510(k) Notification

510(k): Surveyor Central Station System Device Summary

Submitter:

Date: November 26, 2013

Amy Yang, Regulatory Affairs Engineer
Mortara Instrument, Inc.
7865 N. 86th Street
Milwaukee, WI 53224

FAX:	(414) 354-4760
Phone:	(414) 354-1600
Contact:	Amy Yang (see above)

Trade Name:	Mortara Surveyor Central Station
Common Name:	Central Station
Classification Name:	Monitor, Physiological, Patient (with Arrhythmia Detection or Alarms)
Classification Description:	Arrhythmia detector and alarm (including ST-segment measurement and alarm)
Classification Regulation:	21 CFR §870.1025
Product Code:	MHX

DEC 0 3 2013#### Legally marketed devices to which S.E. is claimed:

Mortara Surveyor Central Station	Predicate 510(k) Number	Predicate Manufacturer / Model
Patient Monitoring	K060135	Mortara Instrument, Inc. / SurveyorTelemetry Central Station
Electrocardiograph	K082946	Mortara Instrument, Inc. / ELI 350Electrocardiograph

Description:

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Abbreviated 510(k) Notification

Technology Comparison:

The Mortara Surveyor utilizes the same or similar technology for each parameter as utilized by the predicate devices.

Intended Use:

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.

Indications for Use:

The Mortara Surveyor Central Station is indicated for use in adult & pediatric patient populations.

In a clinical setting, by qualified medical 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 therventions in individual patients or groups of patients.
Clinical and epidemiological research studies. .

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Abbreviated 510(k) Notification

Performance Testing:

Sterilization Validation:

The Mortara Surveyor Central Station is not sterilizable, and therefore this section does not apply to the monitor itself.

Shelf Life Testing:

The Mortara Surveyor Central Station is not sterilizable, and therefore this section does not apply to the monitor itself.

Biocompatibility Testing:

The electrodes, transmitter and monitor housing and patient cable are parts of the system that come in contact with the patient. These component devices have been previously tested in their own right for other submissions and found to be acceptable. However, the Surveyor Central Station itself does not involve direct / indirect patient contact.

Software Testing:

Software for the Mortara Surveyor Central Station was designed and developed according to a robust software development process, and was rigorously verfied and validated. Test results indicated that the Mortara Surveyor Central Station complies with its predetermined specification.

Electrical Safety:

The Mortara Surveyor Central Station was evaluated for patient safety in accordance with applicable Standards.

Electromagnetic Compatibility Testing:

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.

Performance Testing - Bench:

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.

Performance Testing - Animal:

Animal performance testing was not performed and is not necessary to demonstrate safety and effectiveness of the Mortara Surveyor Central Station.

Performance Testing - Clinical:

Clinical performance testing was not performed and is not necessary to demonstrate safety and effectiveness of the Mortara Surveyor Central Station.

Conclusion:

Based upon a comparison of devices and performance testing results, the Mortara Surveyor Central Station is substantially equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes extending from its body, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 3, 2013

Mortara Instrument, Inc. % Amy Yang, BSBE, MBA, RAC Senior Regulatory Affairs Engineer 7865 North 86th St. Milwaukee, WI 53224 US

Re: K131929

Trade/Device Name: Surveyor Central Station Regulation Number: 21 CFR 870.1025 Regulation Name: Monitor, Physiological, Patient (With Arrhythmia Detection Or Alams) Regulatory Class: Class II Product Code: MHX Dated: October 18, 2013 Received: October 21, 2013

Dear Ms. Yang:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Amy Yang

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (2) CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Owen Paris -S

for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

K131929 510(k) Number (if known):_

Device Name: Mortara Surveyor Central System

Indications for Use:

The Surveyor Central System 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. .

AND/OR Prescription Use X (21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).

(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.