The Propaq M is intended for use by trained medical personnel who are familiar with basic monitoring, vital sign assessment, and the use of the Propaq M. The Propaq M is also intended for use by (or on the order of) physicians at the scene of an emergency or in a hospital emergency room, intensive care unit, cardiac care unit, or other similar areas of a hospital. The usage may be in an ambulance or at the scene of an emergency. It is also intended to be used during the transport of patients. The Propaq M will be used whenever it is required to monitor any of those functions that are included (as options) in the device. The Propaq M unit can be used on pediatric patients (as described in the following table) and on adult patients (21 years of age or older) with and without heart dysfunction.

ECG Monitoring: The Propaq M is intended for use to monitor and/or record 3-, 5-, or 12-lead ECG waveform and heart rate, and to alarm when heart rate is above or below limits set by the operator. The patient population will range from newborn (neonate) to adult, with and without heart dysfunction.

Non-Invasive Blood Pressure Monitoring: The Propag M is intended for use to make non-invasive measurements of arterial pressure and heart rate, and to alarm if either parameter is outside of the limits set by the user. Measurements are made using an inflatable cuff on the patient's arm or leg. The patient population will range from newborn (neonate) to adult.

Device Description

Not Found

AI/ML Overview

Here's an analysis of the provided text, focusing on the acceptance criteria and the study details:

This document is a 510(k) clearance letter for the Zoll Propaq M Monitor. It approves the marketing of the device based on its substantial equivalence to previously marketed devices. It does not contain information about a study conducted to prove the device meets specific acceptance criteria in the manner typically described for AI/ML device evaluations.

The information provided describes the intended use and indications for use for various monitoring functions, and mentions patient populations. However, it does not include data from a performance study comparing the device's output to defined acceptance criteria. This type of regulatory submission (510(k) premarket notification) for a cardiac monitor typically relies on verification and validation testing demonstrating the device meets its own specifications, rather than a large-scale clinical study for performance metrics like sensitivity and specificity against a ground truth as would be seen for an AI/ML diagnostic or screening tool.

Therefore, many of the requested fields cannot be filled from the provided text because the document does not describe the kind of study implied by the prompt.

Here's what can be extracted and what cannot:

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

Cannot provide this from the text. The document describes the device's intended functions (ECG monitoring, non-invasive blood pressure monitoring, heart rate alarming) and its patient populations (newborn to adult). It does not present specific performance metrics (e.g., accuracy, sensitivity, specificity, or precision) against numerical acceptance criteria.

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

Cannot provide this from the text. The document does not describe a clinical test set or its sample size.

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 provide this from the text. The document does not describe the establishment of ground truth by experts for a test set.

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

Cannot provide this from the text. The document does not describe a test set or its adjudication.

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 such study was done. This device is a cardiac monitor, not an AI-assisted diagnostic tool. The document describes a medical device for vital sign monitoring, not a system that assists human readers in interpreting images or data. Therefore, an MRMC study related to AI assistance is not applicable and not mentioned.

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

Not applicable as described for AI/ML. The Propaq M is a physical medical device (monitor) that performs measurements and displays data. While it contains algorithms for signal processing and parameter calculation, the concept of "standalone algorithm" performance in the context of AI/ML is not directly relevant here in the way it would be for a diagnostic algorithm. The device itself is "standalone" in its function as a monitor, but the document does not detail validation of its internal algorithms in isolation from the hardware.

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

Cannot provide this from the text in the context of a performance study. For a cardiac monitor, "ground truth" would typically relate to the accuracy of the physical sensors and internal signal processing against known standards or reference devices (e.g., an ECG simulator, a calibrated pressure transducer). However, the document does not detail these technical performance tests or the "ground truth" used for them.

8. The sample size for the training set

Cannot provide this from the text. This device is a traditional medical monitor, not an AI/ML device that requires a "training set."

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

Cannot provide this from the text. This device is a traditional medical monitor, not an AI/ML device that requires a "training set."

Summary of what the document does provide:

Device Name: Zoll Propaq M Monitor
Regulatory Class: Class II
Product Codes: DRT, DXN, DSK, CCK, DQA
Intended Users: Trained medical personnel, physicians at emergency scenes or in hospital settings (emergency room, ICU, CCU, etc.).
Usage Environments: Ambulance, emergency scene, patient transport, hospital.
Patient Populations: Newborn (neonate, birth-1 month), Infant (1 month-2 years), Child (2-12 years), Adolescent (12-21 years), and Adult (21 years or older). Used on patients with and without heart dysfunction.
Specific Functions (Indications for Use):
- ECG Monitoring: Monitor and/or record 3-, 5-, or 12-lead ECG waveform and heart rate; alarm for heart rate outside operator-set limits.
- Non-Invasive Blood Pressure Monitoring: Make non-invasive measurements of arterial pressure and heart rate using an inflatable cuff; alarm if either parameter is outside user-set limits.

This document serves as a regulatory clearance for a traditional medical device based on substantial equivalence, not a detailed performance study report for an AI/ML diagnostic or screening algorithm against specific clinical acceptance criteria.

Summary

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

SEP 15 2010

. .: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Zoll Medical Corporation c/o Mr. Paul Dias Vice President, Quality Assurance and Regulatory Affairs 269 Mill Road Chelmsford, MA 01824-4105

Re: K102174

Trade/Device Name: Zoll Propaq M Monitor Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac monitor (including cardiotachometer and rate alarm), Regulatory Class: Class II (two) Product Code: DRT, DXN, DSK, CCK, DQA Dated: July 30, 2010 Received: August 3, 2010

Dear Mr. Dias:

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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 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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Page 2 - Mr. Paul Dias

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 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/CDRHQffices/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/ReportalProblem/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/ResourcesforYou/Industry/default.htm.

Sincerely yours;

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): ·

Device Name: ZOLL Propag M

Indications For Use:

Propaq M Indications for Use

Pediatric Patient Subpopulation	Approximate Age Range
Newborn (neonate)	Birth to 1 month of age.
Infant	1 month to 2 years of age.
Child	2 to 12 years of age.
Adolescent	12 to 21 years of age.

ECG Monitoring

The Propaq M is intended for use to monitor and/or record 3-, 5-, or 12-lead ECG waveform and heart rate, and to alarm when heart rate is above or below limits set by the operator. The patient population will range from newborn (neonate) to adult, with and without heart dysfunction.

Non-Invasive Blood Pressure Monitoring

The Propag M is intended for use to make non-invasive measurements of arterial pressure and heart rate, and to alarm if either parameter is outside of the limits set by the user. Measurements are made using an inflatable cuff on the patient's arm or leg. The patient population will range from newborn (neonate) to adult.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

W.M.C.

onearence of CDRH, Office of Device Evaluation (ODE)

vision of Cardiovascular Devic

510(k) Number	K102174
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Regulation Number and Section

§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).

(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).