MFM-CMS is a software application that is intended for use as a clinical data managing system (also referred to as a clinical information system - CIS).The MFM-CMS Central Monitoring System offers centralized physiological information management of adult, pediatric and neonatal patients which is automatically acquired from multiple bedside monitors. The MFM-CMS provides: collection, display and documentation of data from bedside monitors, viewing of patient physiologic data at remote locations and alarms when the results of the physiologic parameters exceed the user defined limit. It operates with off-the-shelf software. The system is intended for use in a hospital/clinical environment.

Device Description

The MFM-CMS Central Monitoring System is a software production which runs on PC platform with Microsoft Windows XP or Microsoft Windows 7 operating system. Through specified EDAN protocol, one MFM-CMS can connect with multi-monitor manufactured by EDAN to collect patients' information and monitoring data such as physiological waveforms, physiological parameters and alarms. The MFM-CMS can also send bidirectional control instructions to bedside monitors to change patients' information, alarm limits, and conduct NIBP measurements. The bedside Patient Physiological Monitors have been cleared by FDA under K101539, K120144, K110922, K113623, K113653 and K120173 separately. The monitoring information collect by the MFM-CMS can be saved and printed. At the same time, the old records can be searched conveniently and quickly.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the EDAN Instruments MFM-CMS Central Monitoring System:

This device documentation does not contain the level of detail typically found in a study demonstrating performance against specific acceptance criteria for an AI/CADe device. The 510(k) summary focuses more on the software's functionality, its classification, and its substantial equivalence to a predicate device. It lacks quantifiable performance metrics against acceptance criteria.

Therefore, for many of your requested points, the answer will be "Not provided in the text."

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

Acceptance Criteria	Reported Device Performance
Not specified in text	Not specified in text

Explanation: The document describes the system's features and intended use but does not define specific performance acceptance criteria (e.g., accuracy, sensitivity, specificity for particular physiological events like arrhythmia detection, or data display latency). Consequently, no reported device performance metrics against such criteria are provided.

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 for Test Set: Not provided in the text.
Data Provenance: Not provided in the text.

Explanation: The document mentions "Verification and validation testing was done on MFM-CMS" and lists "Software testing," "Risk analysis," "Safety testing," and "Performance test" as quality assurance measures. However, it does not detail the nature of these "tests," nor does it specify any test datasets, their sizes, or their origin.

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 provided in the text.
Qualifications of Experts: Not provided in the text.

Explanation: Since no detailed performance study or test set is described, there's no mention of experts or their role in establishing ground truth.

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

Adjudication Method: Not provided in the text.

Explanation: As no test set with expert ground truth is described, there's no mention of an adjudication method.

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: No, an MRMC comparative effectiveness study was not conducted or described.
Effect Size of Human Improvement: Not applicable, as no such study was performed.

Explanation: The MFM-CMS is a central monitoring system for displaying physiological data and alarms from bedside monitors, not a diagnostic AI/CADe device designed to assist human readers in interpreting images or signals more effectively. Its primary function is data aggregation and display. Therefore, an MRMC study comparing human performance with and without AI assistance is not relevant to this type of device and was not conducted.

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

Standalone Performance Study: Not described in the text in terms of quantifiable metrics.

Explanation: The "Performance test" mentioned is too vague to determine if it constituted a standalone performance study with specific metrics. The device's primary function is to process and display data, not necessarily to perform standalone diagnostic calculations that would have defined standalone accuracy metrics. It is a "software production" that runs on a PC and monitors data, and connectivity/display functionality would be the main "performance" aspects.

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

Type of Ground Truth: Not provided in the text.

Explanation: Without details on any specific performance tests, the method for establishing ground truth is not described.

8. The sample size for the training set

Sample Size for Training Set: Not applicable / Not provided in the text.

Explanation: This device is a software application for data collection, display, and alarm management. It is not an AI/Machine Learning device in the sense that it requires a "training set" to learn to perform a diagnostic task. It relies on predefined protocols and inputs from connected monitors.

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

How Ground Truth for Training Set was Established: Not applicable / Not provided in the text.

Explanation: As it's not an AI/ML device requiring a training set, the concept of establishing ground truth for training is not relevant here.

Summary

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510(K)Summary of Safety and Effectiveness

This summary of 510k safety and effectiveness is being submitted in according with 21CFR part 807.92

Submitter:	Edan Instruments, Inc3/F - B, Nanshan MedicalEquipments Park, Nanhai Rd 1019#,shekou, Nanshan Shenzhen,518067 P.R. ChinaTel: +86755 26882220Fax:+86 755 26882223
Contact person:	Cherry Sun
Preparing date:	2012-08-10
Proprietary Name:	Central Monitoring System (model MFM-CMS)
Classificationinformation:	870.1025 monitor, physiological, patient(with arrhythmiadetection or alarms)Class II
Product code:	MHX
Predicate Devices:	HYPERVISOR VI Central Monitoring System (K062194)
Device Description:	The MFM-CMS Central Monitoring System is a softwareproduction which runs on PC platform with MicrosoftWindows XP or Microsoft Windows 7 operating system.Through specified EDAN protocol, one MFM-CMS canconnect with multi-monitor manufactured by EDAN tocollect patients' information and monitoring data such asphysiological waveforms, physiological parameters andalarms. The MFM-CMS can also send bidirectional controlinstructions to bedside monitors to change patients'information, alarm limits, and conduct NIBP measurements.The bedside Patient Physiological Monitors have beencleared by FDA under K101539, K120144, K110922,K113623, K113653 and K120173 separately. The monitoringinformation collect by the MFM-CMS can be saved and

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printed. At the same time, the old records can be searched conveniently and quickly.

Device features:

Connect maximum 64 bedside patient monitors with . � Ethernet.
� Waveforms of each bedside monitor that can be displayed on the MFM-CMS include:

2 ECG waveform

l RESP waveform
1 PLETH waveform

8 IBP waveform

1 CO2 waveform

4 AG waveforms for CO2, O2, N2O and AA
Parameters of each bedside monitor that can be displayed on the MFM-CMS include:

ECG: HR, ST value, PVCs RESP: RR NIBP: SYS, DIA, MAP SPO2: SPO2, PR IBP: ART, PA, CVP, RAP, ICP, LAP, P1, P2 (only IBP supported by the monitor will be displayed) CO2: EtCO2, FiCO2, AwRR TEMP: T1, T2, TD AG: EtCO2, FiCO2, AwRR; EtO2, FiO2; EtN2O, FiN2O; HAL/ISO/ENF/SEV/DES: Et, Fi, MAC C.O.: C.O., TB

· The central monitoring supports one or two displays. It can display up to 32 bedside monitors on one display and 64 bedside monitors on two displays simultaneously,
. 240-hour trend data, 72-hour waveform, 720 alarm events, 1~12 hour short trend, 720-group NIBP measurement review for each bedside monitor.
Drug calculation and titration table. .
Print patient information, wave review, alarm review, . trend review, NIBP review, and drug calculation result.
Audible & visible alarm.

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. Web observation in the hospital local area network.
Bidirectional control ●
HL7

MFM-CMS provides centralized monitoring and critical care Intended Use: management for patients monitored by EDAN bedside monitors. From MFM-CMS, clinicians can gain access to patient information for patients on the Network. MFM-CMS displays waveforms, parameters and alarm status of EDAN bedside monitors for up to 32 patients on a single screen or up to 64 patients using two screens.

The following quality assurance measures were applied to Test Summary: the development of the MFM-CMS.

Software testing
Risk analysis
Safety testing ●
Performance test .

Conclusion: Verification and validation testing was done on MFM-CMS. This premarket notification submission demonstrates that the subject device MFM-CMS 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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with medicine and healthcare, featuring a staff with a serpent entwined around it.

Public Health Service

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

June 21, 2013

Edan Instruments, Inc. c/o Mr. Randy Jiang, Certification Engineer 3/F - B, Nanshan Medical Equipments Park Nanhai Rd. 1019# Shenzhen, Guangdong 518067 CHINA

Re: K120727

Trade/Device Names: MFM-CMS Central Monitoring System Regulatory Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm (Including ST-segment Measurement and Alarm) Regulatory Class: Class II (Two) Product Code: MHX Dated: June 3, 2013 Received: June 6, 2013

Dear Mr. Jiang:

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 - Mr. Randy Jiang

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Owen P. Faris -S

for Bram D. Zuckerman

Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number:

Device Name: Central Monitoring System (model MFM-CMS)

× Prescription Use (21 CFR Part 801 Subpart D)

Over the Counter Use (21 CFR Part 801 Subpart C)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Ow
201
15:0

Owen P. Faris -S 2013.06.21 15:01:01 -04'00'

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.