The CADENCE II fetal monitor is used to monitor fetal well being during the antepartum period what is commonly called the non stress test. It is to be used by trained medical personnel in hospitals, clinics, physicians offices and in the patients home by prescription or doctors orders.

Device Description

The CADENCE II Fetal Monitor can provide different configurations according to different user requirements, FHR1 (US1), FHR2 (US2), TOCO, FM (remote marker), AFM (automatic fetal movement mark), fetal stimulator (optional), DECG (direct fetal ECG, optional), and IUP (Intra-uterine Pressure, optional). The user can select the monitors according to requirements.

CADENCE II adopts 5.7" LCD, and the collected data, trends, and monitoring parameters are displayed at the same screen. A built-in thermal recorder is used to record the monitoring information.

AI/ML Overview

The provided text is a 510(k) summary for the CADENCE II Fetal Monitor. This document describes the device and its intended use, but it does not contain specific acceptance criteria or a study proving the device meets those criteria from an objective performance standpoint. Instead, it focuses on demonstrating substantial equivalence to a predicate device.

Therefore, many of the requested details about acceptance criteria, specific performance metrics, and study methodologies cannot be extracted from this document.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

Cannot be provided from the text. The document does not define specific performance acceptance criteria for the CADENCE II, nor does it present a table of reported performance against such criteria. It focuses on demonstrating substantial equivalence to a predicate device based on design, principle of operations, and overall performance, rather than specific quantitative performance metrics from a new study.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Cannot be provided from the text. The document does not describe a performance study with a test set, sample sizes, or data provenance information.

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)

Cannot be provided from the text. No information about experts or ground truth establishment for a test set is included.

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

Cannot be provided from the text. No details about test set adjudication are present.

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

Cannot be provided from the text. This device is a fetal monitor, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study or AI-assistance effect size is not applicable and not mentioned.

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

Cannot be provided from the text. The document does not describe performance studies for the device as a standalone algorithm. The CADENCE II is a monitoring system intended for use by trained medical personnel.

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

Cannot be provided from the text. No information about ground truth for any performance evaluation is given.

8. The sample size for the training set

Cannot be provided from the text. This document does not describe an AI or machine learning model that would require a training set.

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

Cannot be provided from the text. As there's no mention of a training set, there's no information on how its ground truth would be established.

Summary of what the document does provide:

Device Name: CADENCE II
Intended Use: To monitor fetal well-being during the antepartum period (non-stress test). To be used by trained medical personnel in hospitals, clinics, physician's offices, and in the patient's home by prescription.
Predicate Device: Cadence [K040903]
Purpose of Submission: To demonstrate substantial equivalence to the predicate device.
Basis for Equivalence: The submitter states that the CADENCE II is substantially equivalent to the predicate device in intended use, design, principle of operations, performance, and contains the same fundamental scientific technology. Modifications were made to the predicate device, and "All design control activities including safety risk analysis and the verification and validation activities conducted as related to the risks proved that the modified CADENCE II is substantially equivalent." This implies that the 'study' to prove equivalence was a comprehensive set of design control activities, risk analysis, and verification/validation, rather than a specific comparative performance study with defined acceptance criteria and a test set against a ground truth.

Summary

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Attachment 6

510(K) SUMMARY

DEC 2 8 2007

CADENCE II

Submitter's Information A.

Name:	Edan Instruments, Inc
Address:	3/F - B, Nanshan Medical
	Equipments Park, Nanhai Rd 1019#,
	shekou, Nanshan Shenzhen,
	518067 P. R. China
Phone:	86-755-26892220
Fax:	86-755-26882223
Contact Person:	Jiang Yucai
Official Correspondent:	William Stern
Date Summary Prepared:	Oct 17, 2007

Device Information

Trade/Device Name:	CADENCE II
Regulation Number:	884.2740

Classification Name: System, Monitoring, Perinatal Regulation Class: Class II Product Code: HGM Classification Panel: Obstetrics/Gynecology

Description of Device

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(Intra-uterine Pressure, optional). The user can select the monitors according to requirements.

CADENCE II adopts 5.7" LCD, and the collected data, trends, and monitoring parameters are displayed at the same screen. A built-in thermal recorder is used to record the monitoring information.

C. Predicate Device Information

Cadence [K040903] [09/02/2004]

D. Indications for Use/Intended Use

E. Substantial Equivalence

1 ls the product a device? YES-The CADENCE II is a device.

Does the new device have the same intended use? YES-The intended use for the CADENCE II is equivalent to that for the Cadence and is as follows:

Intended Use: Cadence

The Cadence fetal monitor is used to monitor fetal well being during the antepartum period what is commonly called the non stress test. It is to be used by trained medical personnel in hospitals, clinics, physicians offices and in the patients home by prescription or doctors orders.

Does the device have technological characteristics the raise new types of safety or effectiveness questions?

NO- The technological characteristics of the CADENCE II raise no new types of safety or effectiveness questions.

Does descriptive or performance information demonstrate equivalence?

YES- Edan Instruments, Inc. believes that the information provided

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in this submission clearly describes the CADENCE II and demonstrates that it is substantially equivalent to the predicate device Cadence

H. Safety Summary

Edan Instruments, Inc. made several modifications to the Cadence cleared under K040903. All design control activities including safety risk analysis and the verification and validation activities conducted as related to the risks proved that the modified CADENCE II is substantially equivalent in intended use, design, principle of operations, performance, and contains the same fundamental scientific technology as the Cadence.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a stylized emblem. The emblem consists of three abstract shapes resembling human figures or birds in flight, arranged in a stacked formation.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 8 2007

Edan Instruments, Inc. % Mr. William Stern Multigon Industries, Inc. 1 Odell Plaza YONKERS NY 10701

Re: K073221

Trade/Device Name: CADENCE II Regulation Number: 21 CFR 884.2740 Regulation Name: Perinatal monitoring system and accessories Regulatory Class: II Product Code: HGM Dated: November 7, 2007 Received: December 5, 2007

Dear Mr. Stern:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the est on ic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Crant on the of the following numbers, based on the regulation number at the top of this letter.

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, recuract CDRH s Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 24/0276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.btml

Sincerely yours.

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Attachment 2

Indications for Use Statement

510 (k)

Number

(if known)

Kot 32a/

CADENCE II Device Name

The CADENCE II fetal monitor is used to monitor fetal well Indications for Use being during the antepartum period what is commonly called the non stress test. It is to be used by trained medical personnel in hospitals, clinics, physicians offices and in the patients home by prescription or doctors orders.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use YES (Per 21 CFR 801 Subpart D) OR

Over-The-Counter Use _ NO

tony m whay

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

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).