CERNER FETALINK+(VERSION1.0) by CERNER CORP.

Cerner FetaLink+ is a software-only application intended for use on iOS mobile devices by obstetrical healthcare clinicians to view near real time the simultaneous measurement of fetal heart rate(s) and uterine contractions waveforms in one view. FetaLink+transforms the ongoing measurements into a visual wave display which conveys the frequency, duration and relative strength of uterine contractions combined with the patient data of pregnant women in the antepartum and/or intrapartum phases of pregnancy.

Device Description

Cerner FetaLink+ is the software application that runs on the user's iPhone or iPad. The application displays patient clinical waveform data including maternal heart rates, maternal oxygen saturation, maternal blood pressure, and uterine contractions. Within the application, the user can view annotations associated to waveform data.

AI/ML Overview

The provided text describes the Cerner FetaLink+ device, its intended use, and a comparison to a predicate device (AirStrip OB®). However, it does not contain information about specific acceptance criteria, a study proving the device meets these criteria, or a detailed breakdown of performance metrics and ground truth establishment typically found in a clinical performance study.

The document refers to various types of internal testing but none of these are presented as a formal study with acceptance criteria and reported performance metrics.

Here is a breakdown of what can be extracted and what information is missing based on your request:

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

No specific quantitative acceptance criteria or reported device performance metrics (e.g., accuracy, sensitivity, specificity) are provided in the document for the FetaLink+ device. The document states:

"Cerner's validation demonstrated that all functional requirements and hazard analysis software mitigations for Cerner FetaLink+ were executed and the expected results achieved. Based on the results of the testing performed, Cerner FetaLink+ was evaluated to be a safe and effective device for use in a live patient environment."

This is a general statement rather than a specific performance metric against a defined acceptance criterion.

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 provided in the document. The text mentions "functional testing," "formative and summative usability," and "interference testing," but does not specify the sample size of data or patients used for these tests, nor the provenance of any data if it were used in performance evaluation.

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 provided in the document. The document describes the device as displaying data, not making diagnoses or interpretations that would require expert ground truth for performance evaluation in the typical sense of AI/CADe devices.

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

This information is not provided in the document.

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

There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study or any assessment of human reader improvement with or without AI assistance. The device is described as a display tool, not an AI-driven diagnostic aid in the traditional sense that would typically involve a MRMC study for AI assistance.

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

The device itself is a "software-only application intended for use on iOS mobile devices by obstetrical healthcare clinicians to view near real time the simultaneous measurement of fetal heart rate(s) and uterine contractions waveforms." It is an information display tool, not an algorithm that performs standalone analysis or makes diagnoses. Therefore, the concept of "standalone performance" for an algorithm that operates without human-in-the-loop is not directly applicable in the way it would be for a CADe/AI device. The "performance" here relates to the accurate display of data, which was likely covered by the "functional testing."

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

As the device's primary function is to display waveform data, the "ground truth" for its performance would likely refer to the accuracy of the displayed data compared to the source data from the monitoring devices. This type of ground truth (e.g., accuracy of data transmission and display) is implied by "functional testing" but not explicitly detailed with specific methods like expert consensus or pathology.

8. The sample size for the training set

This information is not applicable/not provided. The device, as described, is a data display application. There is no indication that it utilizes machine learning or AI models that would require a "training set" in the context of typical AI device development.

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

This information is not applicable/not provided for the same reason as point 8.

Summary of what is present:

The document focuses on:

Description of the Device: FetaLink+ displays continuous fetal heart rate, uterine contraction waveforms, and other maternal vital signs and clinical data on iOS devices.
Intended Use: For obstetrical healthcare clinicians to view near real-time and historical waveform data.
Comparison to Predicate Device: Detail similarities in functionality with AirStrip OB®.
Performance Testing (General): Mentions "functional testing," "hazard analysis," "unit testing," "regression testing," "exploratory testing," "assembly testing," "formative and summative usability," and "interference testing."
Conclusions: States that all functional requirements were met, usability issues were mitigated, and the device was found to be "adequately safe and effective."

In conclusion, while the document confirms that testing was conducted and the device was deemed safe and effective, it lacks the specific, quantifiable acceptance criteria and detailed study results (including sample sizes, ground truth methods, and expert involvement) that would be expected for a comprehensive performance study of a device making diagnostic-type claims or using advanced AI. The device appears to be a data display tool, and its "performance" testing likely centered on accurate data presentation and application functionality, rather than diagnostic accuracy against a clinical ground truth.

Summary

{0}------------------------------------------------

Cerner Corporation

Cerner FetaLink+ ™

K 121758

510(k) Summary

Submitter's Name: Submitter's Address:

Submitter's Telephone:

Submitter's Contact:

Cerner Corporation 10234 Marion Park Drive Kansas City, MO 64137

816-221-1024

Shelley S. Looby, Director Regulatory Affairs 816-201-1368 (office) 816-885-3069 (mobile) slooby@cerner.com

Date 510(k) Summary Prepared:

September 10, 2012

Trade/Proprietary Name: Cerner FetaLink+™ (Version 1.0) FetaLink+™ Common/Usual Name: Classification Name: Obstetrical and Gynecological Monitoring Devices Classification Regulation: 884.2740 Regulation Description: Perinatal Monitoring System and AccessoriesProduct Code: HGM Classification: Class II

Predicate Device:

Manufacturer:

AirStrip OB®

AirStrip Technologies 335 E Sonterra Blvd Suite 200 San Antonio, TX 78258

510(k) Number:

K090269

OCT 9 2012

{1}------------------------------------------------

510(k) Summary

Description of the Device

Statement of Intended Use

Summary of the technological characteristics of the device compared to the predicate device

Company	Cerner Corporation	AirStrip Technologies
Model	FetaLink+	Airstrip OB
System Characteristics
OperatingSystem	IOS 5.1	IOS 5.0, Android, Blackberry,Windows Mobile
OperatorInterfaces	Mobile hand-held device withtouch screen and virtualkeyboard	Mobile hand-held device withtouch screen or keypad

Information to support substantial equivalence claims is summarized below.

{2}------------------------------------------------

Company	Cerner Corporation	AirStrip Technologies
Model	FetaLink+	Airstrip OB
NetworkValidationRequired?	Yes. It is the customer'sresponsibility to perform networkvalidation.	Yes. It is the customer'sresponsibility to perform networkvalidation.
Patient List	View census (all laboringpatients), grouped by location.Displays the followingdemographic information on thepatient list:Patient First Name Patient Middle Name Patient Last Name Patient Age Physician Name Patient Photo	View census (all laboringpatients), grouped by location.Displays the followingdemographic information on thepatient list:Patient First Name Patient Middle Name Patient Last Name Patient Age Physician Name
TargetPopulation	Pregnant patients monitored onvarious fetal monitoring medicaldevices	Pregnant patients monitored onvarious fetal monitoring medicaldevices
Company	Cerner Corporation	AirStrip Technologies
Model	FetaLink+	Airstrip OB
Clinical Data	Displays the following clinicalinformation relevant topregnancy:• Gravida• Para• Maternal Temperature• Maternal Pulse• Maternal Systolic BP• Maternal Diastolic BP• Maternal SPO2• Cervical Dilation• Cervical Effacement• Fetal Station• Fetal Count• Membrane Status• Epidural Status• EDD• EGA	Displays the following clinicalinformation relevant topregnancy:• Gravida• Para• Maternal Temperature• Maternal Pulse• Maternal Systolic BP• Maternal Diastolic BP• Maternal SPO2• Cervical Dilation• Cervical Effacement• Fetal Station• Fetal Count• Membrane Status• Epidural Status• EDD
Live waveformdata	Graphical display of fetal heartrates and contraction data innear real time. Specifically: Willdisplay the following read-onlywaveform elements:• Baby 1 Heart RateWaveform Data• Baby 2 Heart RateWaveform Data• Baby 3 Heart RateWaveform Data• Baby 4 Heart RateWaveform Data• Maternal Uterine ActivityWaveform Data• Annotations	Graphical display of fetal heartrates and contraction data innear real time. Specifically: Willdisplay the following read-onlywaveform data elements:• Baby 1 Heart RateWaveform Data• Baby 2 Heart RateWaveform Data• Maternal Uterine ActivityWaveform Data• Annotations
Company	Cerner Corporation	AirStrip Technologies
Model	FetaLink+	Airstrip OB
Historical viewof waveformdata	Ability to navigate to viewhistorical waveform data of thecurrent monitored episode.Specifically: Will display thefollowing read-only historicalwaveform data elements:Baby 1 Heart RateWaveform Data Baby 2 Heart RateWaveform Data Baby 3 Heart RateWaveform Data Baby 4 Heart RateWaveform Data Maternal Uterine ActivityWaveform Data Annotations	Ability to navigate to viewhistorical waveform data of thecurrent monitored episode.Specifically: Will display thefollowing read-only historicalwaveform data elements:Baby 1 Heart RateWaveform Data Baby 2 Heart RateWaveform Data Maternal Uterine ActivityWaveform Data Annotations

· . ·

{3}------------------------------------------------

・

: :

・

{4}------------------------------------------------

Like Airstrip OB, Cerner FetaLink+ is designed to be used by obstetrical health providers in a clinical setting. Both systems share the capabilities listed below:

· Provide a dynamic near real time view of the graphical display of the relationship between fetal heart rates and contraction data which can be accessed remotely using a hand held device

Summary of Performance Testing

The testing performed was intended to ensure the functional requirements have been implemented and that hazards identified in the Device Hazard Analysis have been mitigated.

Cerner's validation demonstrated that all functional requirements and hazard analysis software mitigations for Cerner FetaLink+ were executed and the expected results achieved. Based on the results of the testing performed, Cerner FetaLink+ was evaluated to be a safe and effective device for use in a live patient environment.

{5}------------------------------------------------

Cerner Corporation

As part of the development and release process, the software goes through internal testing, which includes the following:

. Unit Testing (Verification)
. Functional Testing (Validation)
Regression Testing .
Exploratory Testing .
Assembly Testing ●

Conclusions

Functional testing, which validated that all functional requirements for the software have been met, were completed prior to formative and summative usability with no outstanding issues identified.

Formative and summative usability, which involved task-based walkthroughs and post-test questionnaire, evaluated possible use errors in the user interface. Based on the results, changes were implemented to mitigate identified use errors.

The results of summative usability and the mitigations applied based on those results show that residual risk has been reduced as low as reasonably practicable.

Interference testing was completed in order to identify and mitigate any risks of interference from clinical or non-clinical devices used in close proximity to the mobile device on which the software resides.

FetaLink+has been found to be adequately safe and effective for the intended users, its intended uses, and use environments.

{6}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with three lines forming its body and wings, symbolizing health, services, and people. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Public Health Service

OCT

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

9 2012

Ms. Shelley S. Looby. MT(ASCP)BB Director, Regulatory Affairs/Quality Assurance Cerner Corporation 10234 Marion Park Drive KANSAS CITY MO 64137

Re: K121758

Trade/Device Name: Cerner FetaLink+TM Regulation Number: 21 CFR§ 884.2740 Regulation Name: Perinatal monitoring system and accessories Regulatory Class: II Product Code: HGM Dated: September 17, 2012 Received: September 19, 2012

Dear Ms. Looby:

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.

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

{7}------------------------------------------------

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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Benjamin K. Evans

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{8}------------------------------------------------

Indications for Use

510(k) Number (if known): K121758 Device Name: Cerner FetaLink+ ™

Indications for Use:

Prescription Use X ._ (Part 21 CFR 801 Subpart D) Over-The-Counter Use n.a. (21 CFR 801 Subpart C)

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

Denjar.
(Division Sign-Of
Concurrence of CDRH, Office of Device Evaluation (ODE)
090 2012

AND/OR

(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K121758

Regulation Number and Section

§ 884.2740 Perinatal monitoring system and accessories.

(a)
Identification. A perinatal monitoring system is a device used to show graphically the relationship between maternal labor and the fetal heart rate by means of combining and coordinating uterine contraction and fetal heart monitors with appropriate displays of the well-being of the fetus during pregnancy, labor, and delivery. This generic type of device may include any of the devices subject to §§ 884.2600, 884.2640, 884.2660, 884.2675, 884.2700, and 884.2720. This generic type of device may include the following accessories: Central monitoring system and remote repeaters, signal analysis and display equipment, patient and equipment supports, and component parts.(b)
Classification. Class II (performance standards).