The ZAP GUARD II device consists of an electrical circuit incorporating resistors and a neon light within the pathway. Upon contact with the paddles of a biphasic defibrillator system which is operational, energy is delivered through the circuit. If the defibrillator system's wires are intact and energy delivery is continuous, then the neon lamp will illuminate.

AI/ML Overview

The provided document is a 510(k) summary for a medical device (ZAP GUARD II, a defibrillator testing probe) and primarily focuses on demonstrating substantial equivalence to a predicate device. It does not contain information about a clinical study with acceptance criteria and device performance in the way typically required for AI/software-as-a-medical-device (SaMD) clearances.

Therefore, many of the requested fields cannot be filled as the information is not present in the provided text.

Here's an attempt to answer based only on the provided document:

Acceptance Criteria and Study to Prove Device Meets Criteria

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Conforms to original voltage and amperage design specifications of the ZAP GUARD.	"Bench testing demonstrated that the ZAP GUARD II conforms to the original voltage and amperage design specifications."
Functionally tests biphasic defibrillator systems as intended.	"The ZAP GUARD II was also functionally tested using a biphasic defibrillator and performed as expected."
Demonstrates safety and effectiveness comparable to the predicate device.	"Performance data demonstrates that the ZAP GUARD II is as safe and effective as the original ZAP GUARD."

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

Sample Size: Not specified. The document mentions "bench testing" and "functionally tested using a biphasic defibrillator" but does not quantify the number of tests or devices involved.
Data Provenance: The testing was conducted by Guardian Angel Products, Inc. (the manufacturer). No information on country of origin of data or whether it was retrospective or prospective. It appears to be an internal, prospective validation of the device design.

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

Not applicable/Not specified. The testing described for this device is physical and electrical performance rather than interpretation by human experts. The "ground truth" seems to be the expected electrical behavior and physical function.

4. Adjudication method for the test set:

Not applicable/Not specified. No expert adjudication method is mentioned as the testing is non-clinical.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a hardware testing probe, not an AI or imaging diagnostic tool that would typically involve human readers.

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

Not applicable directly in the context of AI/algorithms. However, the performance described is that of the standalone device (ZAP GUARD II) functioning independently to test a defibrillator, without human interpretation of its internal workings to achieve the test result (i.e., the neon light illuminates or not).

7. The type of ground truth used:

The ground truth for the performance testing appears to be based on:
- Design Specifications: Conformance to pre-defined voltage and amperage requirements for the electrical circuit.
- Expected Functional Behavior: The verifiable illumination of the neon lamp when connected to an operational biphasic defibrillator with intact wiring, indicating correct function.

8. The sample size for the training set:

Not applicable. This device is a hardware product, not a machine learning model, so there is no "training set."

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

Not applicable. As noted above, there is no training set mentioned.

Summary

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JUL 1 1 2003

K0305477

510(k) SUMMARY Guardian Angel Product's ZAP GUARD II

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Guardian Angel Products, Inc. 2771 Philmont Ave Huntingdon Valley, PA 19006

Phone: 215-938-7677 Facsimile: 215-947-2280

Contact Person: Ernest H. Pescatore June 2003 Date Prepared:

Name of Device and Name/Address of Sponsor/Applicant

ZAP GUARD II

Guardian Angel Products, Inc. 2771 Philmont Ave Huntingdon Valley, PA 19006

Common or Usual Name: Defibrillator Testing Probe

Classification Name: Tester, Defibrillator

Predicate Devices: ZAP GUARD (K896985)

Purpose of 510(k):

The purpose of this Special 510(k) is to modify the ZAP GUARD device used for testing monophasic defibrillator systems. The differences between the devices is that the resistor configuration of the new device was modified for use in testing biphasic defibrillator systems.

Intended Use:

The ZAP GUARD II is intended to be used for the testing of the continuity and the integrity of the wires of Biphasic Defibrillator Systems.

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GUARDIAN ANGEL PRODUCT INC.'S ZAP GUARD II 510(K) SUMMARY PAGE 2

Technological Characteristics:

Performance Data

Bench testing demonstrated that the ZAP GUARD II conforms to the original voltage and amperage design specifications. The ZAP GUARD II was also functionally tested using a biphasic defibrillator and performed as expected.

Substantial Equivalence

The Zap Guard II has the same intended use, principles of operation, and technological characteristics as the original ZAP GUARD device. The minor differences in the ZAP GUARD II do not raise any new questions of safety or effectiveness. Performance data demonstrates that the ZAP GUARD II is as safe and effective as the original ZAP GUARD. Thus, the ZAP GUARD II is substantially equivalent to its predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its wings, head, and body. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the circle's perimeter.

JUL 1 1 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Guardian Angel Products, Inc. c/o Mr. Ernest Pescatore 2771 Philmont Avenue Huntingdon Valley, PA 19006

Re: K030547

Trade/Device Name: Zap Guard II Defibrillator Test Probe Regulation Number: 21 CFR 870.5325 Regulation Name: Defibrillator tester Regulatory Class: Class II (two) Product Code: DRL Dated: June 11, 2003 Received: June 11, 2003

Dear Mr. Pescatore:

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.

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

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Page 2 - Mr. Ernest Pescatore

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 electronic 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 Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

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 Statement

510(k) Number (if known): K030547

Device Name: ZAP GUARD II

Indications for Use:

The ZAP GUARD II is intended to be used for testing the continuity and integrity of the wires of Biphasic Defibrillator Systems.

(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 of Cardiovascular Devices
510(k) Number	K030547

Prescription Use	X	OR	Over-The-Counter
Use
(Per 21 C.F.R. 801.109)

(Optional Format 1-2-96)

Regulation Number and Section

§ 870.5325 Defibrillator tester.

(a)
Identification. A defibrillator tester is a device that is connected to the output of a defibrillator and is used to measure the energy delivered by the defibrillator into a standard resistive load. Some testers also provide waveform information.(b)
Classification. Class II (performance standards).