The Fetalgard 3000 Fetal Monitor is a Perinatal Monitoring System for showing graphically the relationship between maternal labor and the fetal heart rate by means of combining and coordinating display of uterine contraction and fetal heart rate measurements. Uterine contractions are monitored using an external tocotonometer or an intrauterine pressure transducer. Fetal heart rate is measured using an external pulsed Doppler ultrasound transducer or directly with a spiral scalp electrode. Maternal heart rate and respiration are measured using standard ECG electrodes. Heart rate, respiration rate, and uterine activity are presented graphically on an LCD display or chart recorder and digitally on LED displays.

AI/ML Overview

The provided text describes modifications to the Analogic Corporation Fetalgard 3000 Fetal Monitor and its substantial equivalence to a predicate device, rather than a study designed to establish new acceptance criteria or prove device performance against specific targets for a novel AI device. Therefore, much of the requested information regarding AI device evaluation is not directly applicable.

Based on the provided information, here's what can be extracted:

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

This document does not specify quantitative acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy) for an AI or algorithm-driven device. Instead, the focus is on maintaining the safety and performance of a modified medical device to be equivalent to an existing predicate device.

Acceptance Criteria (Implied)	Reported Device Performance
All functions potentially affected by modifications still in compliance with original user requirements.	Demonstrated compliance with original user requirements through testing.
Safety not adversely affected.	Safety maintained through testing.
Performance not adversely affected.	Performance maintained through testing.
Performance substantially equivalent to the predicate device.	Testing of the modified device demonstrates the performance is substantially equivalent to the predicate device.

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

Sample Size for Test Set: Not specified. The document only mentions "a subset of the original verification and validation test scenarios" and the use of "both simulated input signals and tape recordings of actual physiological waveforms."
Data Provenance: The document mentions "tape recordings of actual physiological waveforms," implying real-world data, but the country of origin is not specified. It is likely US-based, given the FDA submission.
Retrospective/Prospective: The use of "tape recordings" suggests retrospective data was used, but the document does not explicitly state this.

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

This information is not provided. The testing primarily focused on verifying that device modifications did not negatively impact its functionality and that it remained equivalent to the predicate device. The concept of "ground truth" as typically applied to AI model validation, especially involving expert consensus for complex interpretations, is not detailed in this submission.

4. Adjudication method for the test set:

Not applicable/Not specified. The testing described focuses on functional verification and performance equivalence to a known predicate, not on subjective interpretation requiring adjudication among experts.

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:

Not applicable. This submission is for modifications to a fetal monitor whose purpose is data display, not for an AI-assisted diagnostic device that would involve human readers or comparative effectiveness studies of AI vs. human performance.

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

The device described is a monitoring system that displays data for human interpretation. While it contains "system software" that "undergone several evolutionary revisions to improve the detection and display of fetal heart rate under adverse conditions," the evaluation described is not a standalone performance assessment of an AI algorithm in the absence of human involvement. The device's intended use is to "aid in assessing the well-being of the fetus," implying human interpretation.

7. The type of ground truth used:

The "ground truth" in this context appears to be the expected correct functional output of the device based on the known characteristics of "simulated input signals and tape recordings of actual physiological waveforms" and comparison against the predicate device's known behavior. It's not "expert consensus," "pathology," or "outcomes data" in the sense used for AI diagnostic tools; rather, it's about accurate measurement and display of physiological signals.

8. The sample size for the training set:

Not applicable. This submission describes modifications to an existing device and its re-validation, not the development or training of a new AI model with a distinct training set. The "system software" improvements were likely based on engineering refinements and testing rather than a formal machine learning training paradigm with a specific dataset.

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

Not applicable. As noted above, this submission does not describe the training of a new AI model where ground truth for a training set would be established. The software revisions are described as "evolutionary," suggesting iterative improvements and bug fixes based on observed performance.

Summary

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AUG 12 1999

510(k) Summary for Analogic Corporation Modifications to Fetalgard 3000 Fetal Monitor

DATE THIS SUMMARY WAS PREPARED: September 11, 1998

SUBMITTER'S NAME AND ADDRESS:

Analogic Corporation 8 Centennial Drive Peabody, MA 01960

CONTACT PERSON:

Steven Clarke, Regulatory Specialist
Telephone	(978)977-3000 extension 2388
Facsimile	(781)245-1274

DEVICE NAME:

Proprietary Name:	Fetalgard 3000 Fetal Monitor (Modification to
Common Name:	Perinatal Monitoring System
Classification Name:	Perinatal Monitoring System and Accessories

PREDICATE DEVICE:

The legally marketed device to which equivalence is being claimed is:

Fetalgard 3000 Fetal Monitor

DEVICE DESCRIPTION:

K98395

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Uterine contractions are monitored using an external tocotonometer or an intrauterine pressure transducer.

Fetal heart rate is measured using an external pulsed Doppler ultrasound transducer or directly with a spiral scalp electrode.

Maternal heart rate and respiration are measured using standard ECG electrodes.

Heart rate, respiration rate, and uterine activity are presented graphically on an LCD display or chart recorder and digitally on LED displays.

INTENDED USE:

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS:

The modified Fetalgard 3000 Fetal Monitor is nearly identical to the predicate Fetalgard 3000 Fetal Monitor which was cleared for marketing under Premarket Notification K950420.

The tocotonometer has been redesigned using the same principle of operation. with changes in the design details to enhance reliability and improve ease of manufacture.

The top housing of the ultrasound transducer will be manufactured out of a different material, which is equivalent in terms of mechanical properties and biocompatibility.

The system software has undergone several evolutionary revisions to improve the detection and display of fetal heart rate under adverse conditions.

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NONCLINICAL TESTS USED IN DETERMINATION OF SUBSTANTIAL EQUIVALENCE:

The modifications to the device have undergone a subset of the original verification and validation test scenarios to show that all functions that may have been affected by the modifications are still in compliance with the original user requirements, and that safety and performance have not been adversely affected. This involved the use of both simulated input signals and tape recordings of actual physiological waveforms.

CONCLUSIONS FROM NONCLINICAL TESTING:

The testing of the modified Fetalgard 3000 Fetal Monitor demonstrates the performance is substantially equivalent to the predicate device.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 12 1999

Mr. Steven A. Clarke, RAC Regulatory Affairs Manager Analogic Corporation 8 Centennial Drive Peabody, MA 01960

Re: K983395 Fetalguard 3000 Fetal Monitor Dated: July 29, 1999 Received: July 30, 1999 Regulatory Class: II 21 CFR §884.2740/Procode: 85 HGM

Dear Mr. Clarke:

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 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 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), piease 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/dsma/dsmamain.html".

Sincerely yours,

[signature]

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): 1

Device Name: _ Fetalgard 3000 Fetal Monitor

Indications For Use:

David C. Seppam
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number .

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Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use OR Over-The-Counter Use (Per 21 CFR 801.109)

Analogic Corporation Fetalgard 3000 510(k)

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).