(a) providing the user the ability to create and use electronic forms for entering, viewing and storing patient and facility related data (e.g. charts, forms, graphs, chalkboards, care plans, user reference manual).
(b) interfacing with other hospital information systems and medical devices for automatic data acquisition, viewing and storage with the electronic patient record.
(c) providing visual notification of when acquired fetal monitor heart rate values exceed the user defined limits for high and low fetal heart rate and poor signal quality.
(d) providing Spectra Alerts capabilities for fetal monitoring (surveillance).
(e) providing automatic computations of physiologic indexes (e.g. nutrition).
(f) providing calculations from user defined formulas (i.e. index calculator).
(g) providing the ability to record, with the patient record, fluid input and oulput information that is defined by the user.
(h) providing the ability to export patient data to relational databases for research and Quality Assurance purposes.
(i) providing the ability to archive files to a secondary or tertiary storage medium (i.e. optical disk).
(i) providing the ability to print (locally or remotely) patient records and QS database definition (e.g. item names)
(k) providing the ability to review fetal monitor data (OB-Link) remotely over the internet.

Device Description

The Quantitative Sentinel (QS) System is a software application that is intended for use as clinical data management system (also referred to as a clinical information system - CIS). The primary function of the system is the management of clinical data (whether manually or automatically acquired) for the purpose of providing integrated, ready and organized access to patient and/or clinical data that would normally be provided on paper records and/or separate clinical systems/devices. The QS System serves as a decision support tool as well as an electronic medical record. The QS System operates on off-the-shelf software and hardware. The device is intended for use in a hospital/clinical environment.

AI/ML Overview

The Quantitative Sentinel System 7.0 is a software application intended for use as a clinical data management system. According to the provided 510(k) summary, "No clinical testing was necessary to demonstrate conformity to performance requirements." Therefore, there is no study described that proves the device meets specific acceptance criteria related to its clinical performance.

The submission focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and extensive software testing to meet its requirements and design.

However, based on the provided text, we can infer some "acceptance criteria" related to functionality and system capabilities, and the "reported device performance" is the statement that these functions are met or enabled.

Here's an attempt to structure the information based on your request, acknowledging the limitations due to the absence of clinical study data:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied from Intended Use/Features)	Reported Device Performance (as stated in 510(k) Summary)
Ability to create and use electronic forms for entering, viewing, and storing patient and facility related data.	Yes (stated in Indications for Use)
Interface with other hospital information systems and medical devices for automatic data acquisition, viewing, and storage.	Yes (stated in Indications for Use & comparison table)
Provide visual notification when acquired fetal monitor heart rate values exceed user-defined limits and for poor signal quality.	Yes (stated in Indications for Use - "Spectra Alerts capabilities for fetal monitoring (surveillance)" and comparison table)
Provide automatic computations of physiologic indexes.	Yes (stated in Indications for Use)
Provide calculations from user-defined formulas.	Yes (stated in Indications for Use)
Provide ability to record fluid input and output information with the patient record.	Yes (stated in Indications for Use)
Provide ability to export patient data to relational databases for research and Quality Assurance purposes.	Yes (stated in Indications for Use)
Provide ability to archive files to a secondary or tertiary storage medium.	Yes (stated in Indications for Use)
Provide ability to print (locally or remotely) patient records and QS database definitions.	Yes (stated in Indications for Use)
Provide ability to review fetal monitor data remotely over the internet.	Yes (stated in Indications for Use & comparison table)
Operate on off-the-shelf software and hardware.	Yes (stated in Device Description & comparison table)
Utilize Network architecture (Ethernet, Token Ring, IBM Wireless LAN).	Yes (stated in comparison table)

2. Sample size used for the test set and the data provenance:

The document explicitly states, "No clinical testing was necessary to demonstrate conformity to performance requirements." Therefore, there is no information provided regarding a clinical "test set" in the context of patient data. The testing mentioned refers to software and environmental testing. The provenance of any data used for internal software testing is not detailed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable, as no clinical test set with expert-established ground truth was reported.

4. Adjudication method for the test set:

Not applicable, as no clinical test set was reported.

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 MRMC study was reported. This device is a data management system, not an AI-assisted diagnostic tool for human readers.

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

The device is a software application intended as a clinical data management system and decision support tool. It is inherently designed to manage and present data for human use. The "performance" described refers to its functional capabilities (e.g., data acquisition, display, calculation, remote access) rather than a standalone diagnostic or interpretive algorithm. The document states "The QS software and its environment have been extensively tested to meet its requirements and design," which implies standalone software functionality testing, but not in the context of a standalone clinical performance without human involvement in interpretation or decision-making.

7. The type of ground truth used:

Not applicable. For software and environmental testing, the "ground truth" would be the predefined functional and performance requirements of the software, verified through testing scenarios. No clinical ground truth (e.g., pathology, outcomes data, expert consensus on patient conditions) was used or reported in the context of clinical performance evaluation.

8. The sample size for the training set:

Not applicable, as no clinical training set was reported. This device does not appear to involve machine learning models that require a training set in the conventional sense.

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

Not applicable.

Summary

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K993008

QUANTITATIVE SENTINEL SYSTEM 7.0 510(k) SUMMARY

Prepared 04 September 1999

[807.92(a)1] Contact Information

Maria Vitug Fouts Sr. Regulatory Compliance Specialist

Address:	GE Marquette Medical Systems, Inc.
	200 Harry S. Truman Parkway, Suite 220
	Annapolis, MD 21401
Phone:	410-573-6294
Fax:	410-897-0349

[807.92(a)2] Device Name and Classification

The proprietary name of the modified device to be introduced into interstate commerce is the Quantitative Sentinel System.

Common names include: QS. QS-5. QS System. QS Perinatal, QS-ICU, and QS-Surveillance, Surveillance & Archive, QS Unit Manager, QS Lab Access

As indicated in the original premarket notification submission, the Quantitative Sentinel System is a class II device. To date no formal classification name has been issued for software based clinical information systems.

[807.92(a)3] Identification of Legally Marketed Equivalent Devices (Predicate Systems)

Predicate System	Manufacturer	k Number
Quantitative SentinelSystem	GE Marquette MedicalSystems, (formerly QuantitativeMedicine, Inc.)200 Harry S. Truman Pkwy.Annapolis, MD 21401	K973608
Corometrics Spectra-TelTelecommunications andDisplay System	Corometrics Medical Systems,Inc.61 Barnes Park Road NorthWallingford, CT 06492	K852608, K894958

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[807.92(a)4 & 807.92(a)5] Device Description & Intended Use

Parameter	QMI's QS SystemVersion 5.04.1	QMI's Predicate QSSystem(K960109)	CorometricsSpectra-Tel(K852608)
Interface HIS,physiologic monitors	Yes	Yes	Yes
Network architecture	Ethernet, Token Ring,or IBM Wireless LAN	Off-the-shelfcomputers andaccessories	No network; modemconnection
Hardware platform	Off-the-shelfcomputers andaccessories	Off-the-shelfcomputers andaccessories	Off-the-shelfcomputers andaccessories
Spectra Alerts	Yes	No	Yes
Remote Access tofetal monitor patientdata	Yes(via web-browser)	Yes(via WAN or modemconnection)	Yes(via modemconnection)

[807.92(a)6] Predicate Device Comparison of Technological Characteristics

[807.92(b)1, 807.92(b)2 & 807.92(b)3] Performance Standards per the Food, Drug and Cosmetic Act

To date, no performance standards relating to devices of this type have been promulgated by the Food and Drug Administration.

[807.92(d)] Additional Information

The QS software and its environment have been extensively tested to meet its requirements and design. No clinical testing was necessary to demonstrate conformity to performance requirements.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" written around it. Inside the circle is a stylized image of an eagle or bird with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 6 1999

Ms. Maria Vitug Fouts Senior Regulatory Compliance Specialist GE Marquette Medical Systems, Inc. 200 Harry S. Truman Parkway, Suite 220 Annapolis, MD 21401

Re: K993008 Quantitative Sentinel (QS) System, Version 5.04.1 Dated: September 7, 1999 Received: September 7, 1999 Requlatory Class: 11 21 CFR§ 884.2740/Procode: 85 HGM

Dear Ms. Fouts:

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 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, 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 (Special Controls) or class III (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 (QS) for Medical Devices: General requlation (21 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 reqult 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 531 through 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 Compiiance 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/dsma/dsmamain.html".

Sincerely yours.

CAPT Daniel G. Schultz, M.D. Acting 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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510(k) Number (if known):

Device Name: Quantitative Sentine! (QS) System

Indications for Use:

The Quantitative Sentinel (QS) System's is intended for automatic patient data management. It does this by:

(a) providing the user the ability to create and use electronic forms for entering, viewing and
storing patient and facility related data (e.g. charts, forms, graphs, chalkboards, care plans, user reference manual).
(b) interfacing with other hospital information systems and medical devices for automatic data acquisition, viewing and storage with the electronic patient record.
(c) providing visual notification of when acquired fetal monitor heart rate values exceed the user defined limits for high and low fetal heart rate and poor signal quality.
(d) providing Spectra Alerts capabilities for fetal monitoring (surveillance).
(e) providing automatic computations of physiologic indexes (e.g. nutrition).
(f) providing calculations from user defined formulas (i.e. index calculator).
(g) providing the ability to record, with the patient record, fluid input and oulput information that is defined by the user.
(h) providing the ability to export patient data to relational databases for research and Quality Assurance purposes.
(i) providing the ability to archive files to a secondary or tertiary storage medium (i.e. optical disk).
(i) providing the ability to print (locally or remotely) patient records and QS database definition (e.g. item names)
(k) providing the ability to review fetal monitor data (OB-Link) remotely over the internet.

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

Concurrence if CDRH, Office of Device Evaluation (ODE)

Prescription Use(Per 21 CFR 801.19)
-----------------------------------------	----------------------------------------------------

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number	K993008
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Over the Counter Use
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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).