The CALM system is intended for use as a central monitoring system with signal analysis and display functions and remote repeaters in the perinatal clinical environment. It interfaces with standard fetal and maternal monitors and provides fetal surveillance, monitoring of labor progress, charting, reporting and data analysis, display and archiving functions.

Device Description

CALM is an easy-to-use system consisting of personal computers, data acquisition modules, and a system server. Interfaced with standard fetal and maternal monitors, CALM helps an Obstetrics Labor and Delivery department with fetal surveillance, charting, and archiving of patient data.

AI/ML Overview

Here's an analysis of the provided text regarding the CALM system's acceptance criteria and study information, formatted as requested:

Acceptance Criteria and Study Information for CALM System (K980719)

It's important to note that the provided 510(k) summary for the CALM system is a substantial equivalence determination rather than a report on a clinical study designed to meet specific performance acceptance criteria. The document's purpose is to demonstrate that the CALM system is as safe and effective as a legally marketed predicate device (Birthnet™ Perinatal Patient Data Management System), based on a comparison of features, intended use, and technical specifications. Therefore, direct "acceptance criteria" and "reported device performance" in the traditional sense of a performance study are not explicitly detailed in the provided text. Instead, substantial equivalence is established by comparing functionalities.

The table below reflects the comparison of features between the CALM system and its predicate device, which implicitly serve as the basis for the FDA's substantial equivalence determination.

1. Table of Acceptance Criteria and the Reported Device Performance

Given that this is a 510(k) summary for substantial equivalence, the "acceptance criteria" are implicitly defined by the functionalities and specifications of the predicate device. The "reported device performance" is a statement of the CALM system's ability to match or perform similarly to these functionalities.

Feature (Implicit Acceptance Criteria based on Predicate)	Reported CALM Device Performance (as presented for Substantial Equivalence)
Intended Use	The CALM system's intended use description matches that of the predicate device, focusing on capturing, displaying, printing, and managing physiological obstetrical and fetal patient data, real-time monitoring of multiple patients, and correlating observations. CALM explicitly notes plotting recorded cervical dilatation versus time and comparing it with a sample population.
Data Collection	Collects FHR and UA data from maternal monitors and caregiver input, matching the predicate.
Sample Rate (FHR)	Samples FHR at a minimum of 4 samples per second, typical of FHR monitors, matching the predicate.
Central Display	Provides central display capability at any required workstation, including Chalkboard and All Tracings display, matching the predicate.
Viewing (selected observations)	Views selected observations for all patients and views FHR and UA data while charting, matching the predicate.
Additional Patient Viewing	With appropriate access privileges, views another patient's observations from any patient's room, matching the predicate.
Chalkboard	Any workstation can be configured to display "Ward Status" chalkboard, matching the predicate.
Communications (data via network)	Communications of data via network to workstations, matching the predicate.
Communications to other Hospital Info System	Uses the ANSI standard Health Level 7 (HL7) v2.3 protocol, matching the predicate (which uses HL7).
Labor Progress Curves	Displays the patient's curve of Cervical Dilatation compared to a reference population (Friedman's curve), matching the predicate's intent to compare with Friedman's curve.
Archiving	Optional - uses Dual optical disk as well as others, matching the predicate's use of Dual optical disk.
Annotation	Bedside annotation of caregiver (doctors and nurses) interventions, a slight expansion from the predicate's "nursing interventions" but still deemed substantially equivalent in scope.
Admission, Transfer & Discharge (ADT)	ADT capability provided for patient visits, matching the predicate.
Calculations	Calculates patient age, fetal gestational age, and estimated date of delivery, expanding slightly on the predicate's calculation of patient age and estimated date of delivery, but still within the scope of perinatal data management.
Reports	Several patient reports available, matching the predicate.
Remote Access	Via Modem, matching the predicate.

Detailed Study Information:

The provided document is a 510(k) summary for the CALM system, and it primarily focuses on demonstrating substantial equivalence to a predicate device (Birthnet™ Perinatal Patient Data Management System, K965008). It does not describe a clinical performance study designed to establish new acceptance criteria or to show performance against such criteria. Instead, it compares the features and intended use of the CALM system to a previously cleared device. Therefore, many of the requested details about performance studies, such as sample sizes, expert qualifications, adjudication methods, MRMC studies, and standalone performance evaluations, are not applicable or not provided in this type of submission.

Here's an attempt to address your points based on the available information:

Sample sizes used for the test set and the data provenance: Not applicable. The document describes a comparison of device features and intended use for substantial equivalence, not a performance test with a distinct test dataset.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No test set requiring ground truth establishment by experts is described in this substantial equivalence summary.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No test set requiring expert adjudication is described.
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: Not applicable. This document predates widespread AI integration in medical devices and describes a data management system, not an AI-assisted diagnostic or interpretation tool. No MRMC study is mentioned.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. The CALM system is a "Computer-based information management system" and a "central monitoring system with signal analysis and display functions." Its function is to interface with existing fetal and maternal monitors and process/display their data, along with caregiver input. It is not an "algorithm only" device in the sense of an AI performing diagnosis without human oversight. Its performance is intrinsically linked to the input from monitors and human interaction.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to this type of submission. The "ground truth" here is the established functionality and performance of the predicate device for comparison.
The sample size for the training set: Not applicable. As this is a data management system being cleared via substantial equivalence, there is no mention of a "training set" in the context of machine learning or algorithm development.
How the ground truth for the training set was established: Not applicable, for the reasons stated above.

Summary

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K980719

JUL 31 1998

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িয়েছে

Image /page/0/Picture/2 description: The image shows a logo for "LMS Medical Systems Limited". The logo features the letters "LMS" in a bold, blocky font, with the words "Medical Systems Limited" written underneath in a smaller font. Above the letters, there is a drawing of two figures, possibly cherubs or angels, in a classical style. The image is in black and white and appears to be a scan or photocopy.

5252 de Maisonneuve Blvd. W., Suite 314 ♦ Montréal, Québec ♦ Canada H4A 3S5 Phone: (514) 488-3461 ♦ Fax: (514) 488-1880

APPENDIX 8 CALM SYSTEM 510(K) SUMMARY [510k Summary.doc ]

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Image /page/1/Picture/0 description: The image shows a logo for LMS Medical Systems Limited. The logo features an illustration of two figures tending to a baby. The text "LMS Medical Systems Limited" is written in a bold, sans-serif font below the illustration.

5252 de Maisonneuve Blvd. W., Suite 314 ♦ Montréal, Québec ♦ Canada H4A 3S5 Phone: (514) 488-3461 ♦ Fax: (514) 488-1880

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510(k) Summary as required by 807.92 ( c ) for CALM Prepared 20th February, 1998

LMS Medical Systems, Ltd. Submitted by: 5252 de Maisonneuve Boulevard West Suite 314 Montreal, Quebec Canada. H4A 3S5
Tel: (514)-488-3461, Fax: (514)-488-1880
Contact Person: Dr. Emily Hamilton, M.D. President

Device Trade Name: CALM

Computer-based information management system for obstetrical Common name: care.
Classification: Perinatal monitoring system and accessories.

Predicate Device: Birthnet TM Perinatal Patient Data Management System manufactured by Advanced Medical Systems, Inc., Sherman Avenue, Hamden, CT. (K965008)

Description of Device: CALM is an easy-to-use system consisting of personal computers, data acquisition modules, and a system server. Interfaced with standard fetal and maternal monitors, CALM helps an Obstetrics Labor and Delivery department with fetal surveillance, charting, and archiving of patient data.

Intended Use of Device: The CALM system is intended for use as a central monitoring system with signal analysis and display functions and remote repeaters in the perinatal clinical environment. It interfaces with standard fetal and maternal monitors and provides fetal surveillance, monitoring or labor progress, charting reporting, and data analysis, display and archiving functions.

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Image /page/2/Picture/0 description: The image shows a logo for LMS Medical Systems Limited. The logo features two figures that appear to be statues, possibly representing a classical or mythological theme. The text "LMS Medical Systems Limited" is written below the figures, with "LMS" in a larger, bolder font size than "Medical Systems Limited."

5252 de Maisonneuve Blvd. W., Suite 314 ♦ Montréal, Québec ♦ Canada H4A 3S5 Phone: (514) 488-3461 ♦ Fax: (514) 488-1880

Substantial Equivalence to Predicate Device:

The Computer Assisted Labor Monitoring (CALM) system is substantially equivalent to the Birthnet™ Perinatal Patient Data Management System manufactured by Advanced Medical Systems Inc, 925 Sherman Avenue, Hamden, CT (K965008). The features between CALM and the predicate device, are identified in the comparison table below:

FEATURE	LMS MEDICAL SYSTEMSCALM	ADVANCED MEDICALSYSTEMSBIRTHNET II
Intended Use	The Computer Assisted LaborMonitoring (CALM) system isdesigned for use to capture,display, print and managephysiological obstetrical andfetal patient data. It isintended to permit the real-time monitoring of multipleobstetrical and fetal patientssimultaneously and tocorrelate pertinent patientobservations of physiologicalparameters. It is also capableof plotting recorded cervicaldilatation versus time, of themonitored patient andcomparing it with a samplepopulation as a reference.	The BirthNet II perinatalPatient Data ManagementSystem is designed for use tocapture, display and managephysiological obstetrical andfetal patient data. It isintended to permit the real-time monitoring of multipleobstetrical and fetal patientssimultaneously and tocorrelate non-monitoredpatient data with monitoredphysiological parameters. Itplots recorded cervicaldilatation versus time for eachpatient.
Data Collection	Collects Fetal Heart Rate(FHR) and Uterine Activity(UA) data from maternalMonitors. It also collects datainput by the caregiver	Collects Fetal Heart Rate(FHR) and Uterine Activity(UA) data from maternalMonitors. It also collects datainput by the caregiver.
Sample Rate	Samples FHR at a minimumof 4 samples per second –typical of data managed byFHR monitors	Samples FHR at a minimumof 4 samples per second –typical of data managed byFHR monitors
Central Display	Central display capabilityprovided at any required WS.This includes Chalkboard andAll Tracings display as well as	Central display capabilityprovided at any required WS.This includes Chalkboard andAll Tracings display as well

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Image /page/3/Picture/0 description: The image shows a logo for LMS Medical Systems Limited. The logo features an image of two figures that appear to be statues. The text "LMS Medical Systems Limited" is written in bold font below the image.

「不要不可能」意味了!!! 出版社会的不同意见是是是是有着了了了

5252 de Maisonneuve Blvd. W., Suite 314 ♦ Montréal, Québec ♦ Canada H4A 3S5
Phone: (514) 488-3461 ♦ Fax: (514) 488-1880

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FEATURE	LMS MEDICAL SYSTEMSCALM	ADVANCED MEDICALSYSTEMSBIRTHNET II
Viewing	selected observations for allpatientsView FHR and UA data whilecharting	as selected observations forall patients.View FHR and UA data whilecharting
Additional patient viewing	With appropriate accessprivileges, view anotherpatient's observations fromany patient's room.	View another patient'sobservations from anypatient's room.
Chalkboard	Any workstation can beconfigured to display "WardStatus" chalkboard.	Any workstation can beconfigured to display "WardStatus" chalkboard.
Communications	Communications of data vianetwork to workstations.	Communications of data vianetwork to workstations
Communications to otherHospital InformationSystem	Uses the ANSI standardHealth Level 7 (HL7) v2.3protocol.	Uses HL7 protocol.
Labor Progress Curves	Displays the patient's curve ofCervical Dilatation comparedto a reference population	Display the patient's CervicalDilatation curve that isintended for comparison withFriedman's curve *
Archiving	Optional -Uses Dual opticaldisk as well as others	Optional - Uses Dual opticaldisk
Annotation	Bedside annotation ofcaregiver (i.e. doctors andnurses) interventions	Bedside annotation of nursinginterventions
Admission, Transfer &Discharge (ADT)	ADT capability provided forpatient visits.	ADT capability provided forpatient visits
Calculations	Calculates patient age, fetalgestational age and estimateddate of delivery	Calculates patient age andestimated date of delivery
Reports	Several patient reportsavailable.	Several patient reportsavailable.
Remote Access	Via Modem	Via Modem

Friedman's curve is the most commonly used Clinical standard

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 3 | 1998

Dr. Emily Hamilton President LMS Medical Systems Ltd. 5252 de Maisonneuve West, Suite 314 Montreal, Quebec CANADA H4A 3S5

Re: K980719 CALM System (Computer Assisted Labor Monitoring) Dated: June 4, 1998 Received: June 10, 1998 Regulatory Class: II 21 CFR 884.2740/Procode: 85 HGM

Dear Dr. Hamilton:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.

If your device is classified (see above) into either class II (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (2) CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmadsmam.html".

Sincerely your

Sincerely yours,

Lillian Yin, Ph.D.

Director, Division of Reproductive, Abdominal. Ear. Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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(510k) Number (if known):

Device Name: CALM (for Computer Assisted Labor Monitoring)

Indications For Use:

The CALM system is intended for use as a central monitoring system with signal analysis and display functions and remotre repeaters in the perinatal clinical environment. It interfaces with standard fetal and maternal monitors and provides fetal surveillance, monitoring of labor progress, charting, reporting and data analysis, display and archiving functions.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)




	(Division Sign-Off)	(Division Sign-Off)
(Division Sign-Off)
	Division of Reproductive, Abdominal, ENT, and Radiological Devices
	510(k) NumberK980719	510(k) Number	K980719
510(k) Number	K980719
Prescription Use (Per 21 CFR 801.109)	OROver-The-Counter Use		OR	Over-The-Counter Use
	OR	Over-The-Counter Use

(Optional Format 1-2-96)

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).