The Powerheart® AED G3 is intended to be used by personnel who have been trained in its operation. The user should be qualified by training in basic life support or other physician-authorized emergency medical response.

The device is indicated for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing. Post-resuscitation, if the victim is breathing, the AED should be left attached to allow for acquisition and detection of the ECG rhythm. If a shockable ventricular tachyarrhythmia recurs, the device will charge automatically and advise the operator to deliver therapy.

When the patient is a child or infant up to 8 years of age, or up to 55 lbs (25kg), the Powerheart® AED G3 should be used with the Model 9730 Pediatric Attenuated Defibrillation Electrodes. The therapy should not be delayed to determine the patient's exact age or weight.

Device Description

The Powerheart® AED G3 is a portable, battery-operated, semi-automatic, low power DC defibrillator. The device is designed to diagnose and monitor the patient's cardiac rhythm and advise the operator if and when to deliver the shock energy. The Powerheart® AED device in this submission is identical to the current Powerheart® AED and accessories in commercial distribution that was cleared under premarket 510(k) notifications K022929, K011901 and K982710. The reason for this premarket notification is to introduce minor modifications to the device and upgrade software.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Cardiac Science Powerheart® AED G3:

Overview:
It's important to note that this 510(k) submission (K031987) is for minor modifications and a software upgrade to an already cleared device. The submission explicitly states: "The Powerheart® AED device in this submission is identical to the current Powerheart® AED and accessories in commercial distribution that was cleared under premarket 510(k) notifications K022929, K011901 and K982710. The reason for this premarket notification is to introduce minor modifications to the device and upgrade software." and "The device modifications do not raise any new issues of safety or effectiveness."

Because of this, the submission doesn't detail a comprehensive new study to establish initial performance metrics but rather to demonstrate that the modifications did not negatively impact the device's existing established performance.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in the typical sense (e.g., Sensitivity > X%, Specificity > Y%). Instead, the "acceptance criteria" appear to be that the modified device performs as intended and that the modifications had no affect on the safety or effectiveness of the device.

Acceptance Criteria (Implied)	Reported Device Performance
Device modifications have no effect on safety or effectiveness.	"The results of the testing showed that the device modifications had no affect on the safety or effectiveness of the device."
Device passes all software and hardware tests.	"The Powerheart® AED G3 passed all software and hardware tests and was found to perform as intended."
Device performs as intended.	"The Powerheart® AED G3 passed all software and hardware tests and was found to perform as intended."
Device is equivalent to the current Powerheart® AED for existing indications, characteristics, materials, function, and software algorithm.	"Cardiac Science has demonstrated...that the device with minor modifications is equivalent to the current Powerheart® AED. The proposed Powerheart® AED G3 is identical with respect to indications for use, technological characteristics, materials, function and software algorithm as the current commercially distributed Powerheart® AED."

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a distinct "test set" with a defined sample size for clinical or algorithm performance evaluation in this submission. The testing conducted was described as "performance hardware and software evaluations."

Sample Size for Test Set: Not explicitly stated as a number of patient cases or ECGs. The text refers to "performance hardware and software evaluations," which are typically done on the device itself through engineering and verification methods rather than biological data sets.
Data Provenance: Not applicable/not specified for this type of evaluation. The "testing" appears to be internal engineering and verification, not clinical data evaluation for algorithm performance on patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This submission focuses on hardware and software verification of minor changes, not the establishment of ground truth for a diagnostic algorithm using expert review of clinical data.

4. Adjudication Method for the Test Set

Not applicable. As noted above, this was not a study involving expert adjudication of a test set of clinical data.

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. This document does not describe an MRMC comparative effectiveness study. The device is an Automatic External Defibrillator (AED), which is largely an automated system designed for lay rescuers or personnel trained in its operation, not for human readers to interpret complex images or data with AI assistance. Its primary function is automated rhythm analysis and shock advisory.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The performance testing described ("performance hardware and software evaluations") would implicitly cover the standalone performance of the algorithm within the device. The "algorithm" for an AED is its ability to accurately detect shockable rhythms (like Ventricular Fibrillation or Ventricular Tachycardia) and differentiate them from non-shockable rhythms. While the document doesn't provide specific standalone sensitivity and specificity numbers, the statement "The Powerheart® AED G3 passed all software and hardware tests and was found to perform as intended" implies that its rhythm analysis algorithm (the core of a standalone AED) met its specifications.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The document does not detail the type of ground truth used for the algorithm's rhythm analysis performance. For AEDs, the ground truth for rhythm analysis (e.g., shockable vs. non-shockable) is typically established by expert cardiologists or electrophysiologists independently reviewing ECG recordings and classifying them. However, for this specific 510(k) (minor changes), the ground truth for the original algorithm's performance would have been established in prior submissions (K022929, K011901, K982710). This submission primarily focuses on demonstrating that the minor modifications did not degrade that previously established performance.

8. The Sample Size for the Training Set

Not applicable/not specified for this submission. The training set for the original AED algorithm would have been part of the initial development and validation process for the predicate devices. This 510(k) is about modifications to an existing device, not the development of a new algorithm requiring a new training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable/not specified. Similar to the test set, the ground truth for the training set (if the algorithm used machine learning, which was less common for AEDs in 2003, but still relevant) would have been established during the development of the original predicate devices, likely through expert review of ECG waveforms.

Summary

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K 03/987

Cardiac Science Powerheart® AED G3 Special Premarket 510(k) Notification

JUL 3 0 2003

SECTION 17: SUMMARY OF SAFETY AND EFFECTIVENESS

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92.

17.1: ADMINSTRATIVE INFORMATION

Name and Address
Submitted by:	Cardiac Science Incorporated
	5474 Feltl Road
	Minnetonka, MN 55343
Contact Person:	Kenneth F. Olson
Telephone No.:	952-939-4181
Facsimile No.:	952-939-4191
Email:	kolson@cardiacscience.com

Date Prepared: June 25, 2003

17.2: DEVICE INFORMATION

Common or Usual Name:	Automatic External Defibrillator
Trade Name:	Powerheart® Automatic External Defibrillator G3Model 9300

17.3: DEVICE CLASSIFICATION

Classification Name:	Automatic External Defibrillator
	21 CFR 870.1025 MKJ
	Device Class:	III

17.4: DEVICE DESCRIPTION

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17.5: INDICATION FOR USE

17.6: IDENTIFICATION OF PREDICATE DEVICE

Company	Device	510(k) No.	Date Cleared
Cardiac Science	Powerheart AED	K022929	01/27/2003
Survivalink	FirstSave Biphasic AED	K011901	02/01/2002
Corporation(Cardiac Science)	(renamed Powerheart AED)	K982264	01/25/1999

17.7: SUBSTANTIAL EQUIVALENCE

The Powerheart® AED G3, Model 9300 covered by this submission is substantially equivalent to other legally marketed automatic external defibrillators. Specifically, the Powerheart® AED G3 that is the subject of this premarket notification is identical to current Powerheart® AED in commercial distribution with the exception of minor device modifications to the hardware and software. The device modifications do not raise any new issues of safety or effectiveness.

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Cardiac Science Powerheart® AED G3 Special Premarket 510(k) Notification

PERFORMANCE TESTING 17.8

The Powerheart® AED G3 was subjected to performance hardware and software evaluations in accordance with FDA guidelines and industry standards. The results of the testing showed that the device modifications had no affect on the safety or effectiveness of the device. The Powerheart® AED G3 passed all software and hardware tests and was found to perform as intended.

CONCLUSIONS 17.9

. '

Cardiac Science has demonstrated through its evaluation and testing of the Powerheart® AED G3, Model 9300, that the device with minor modifications is equivalent to the current Powerheart® AED. The proposed Powerheart® AED G3 is identical with respect to indications for use, technological characteristics, materials, function and software algorithm as the current commercially distributed Powerheart® AED. This notification contains all information required by 21 CFR 807.87. A completed copy of the Premarket Notification 510(k) Reviewer's Checklist is provided in this submission.

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Public Health Service

Image /page/3/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with its wings spread, surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The eagle is composed of three curved lines, giving it a modern and abstract appearance. The overall design is simple and recognizable, representing the department's role in public health and human services.

Food and Druq Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 3 0 2003

Cardiac Science, Inc. Minneapolis Operations c/o Mr. Kenneth Olson Chief Technical Officer 5474 Feltl Rd. Minneapolis, MN 55343

K031987 Re: PowerHeart AED G3, Model 9300 Regulation Number: 870.1025 Regulation Name: Arrhythmia Defector and Alarm Regulatory Class: Class III Product Code: MKJ Dated: July 18, 2003 Received: July 21, 2003

Dear Mr. Olson:

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. Iisting 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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Page 2 - Kenneth Olson

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 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. 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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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

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Cardiac Science Powerheart® AED G3 Special Premarket 510(k) Notification

INDICATIONS FOR USE

510(k) Number:

Device Name:	Powerheart® Automatic External Defibrillator G3Model 9300
Indications for Use:	The Powerheart® AED G3 is intended to be used by personnel who have been trained in its operation. The user should be qualified by training in basic life support or other physician-authorized emergency medical response.
	The device is indicated for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing. Post-resuscitation, if the victim is breathing, the AED should be left attached to allow for acquisition and detection of the ECG rhythm. If a shockable ventricular tachyarrhythmia recurs, the device will charge automatically and advise the operator to deliver therapy.
	When a patient is a child or infant up to 8 years of age, or up to 55 lbs (25kg), the Powerheart AED G3 should be used with the Model 9730 Pediatric Attentuated Defibrillation Electrodes. The therapy should not be delayed to determine the patient's exact age or weight.
	(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
	Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use(Per 21 CFR 801.109)	OR
	Over-The-Counter Use

	(Division Sign-Off)
	Division of Cardiovascular Devices
510(k) Number	K031987

510(k) Number_

Regulation Number and Section

§ 870.5310 Automated external defibrillator system.

(a)
Identification. An automated external defibrillator (AED) system consists of an AED and those accessories necessary for the AED to detect and interpret an electrocardiogram and deliver an electrical shock (e.g., battery, pad electrode, adapter, and hardware key for pediatric use). An AED system analyzes the patient's electrocardiogram, interprets the cardiac rhythm, and automatically delivers an electrical shock (fully automated AED), or advises the user to deliver the shock (semi-automated or shock advisory AED) to treat ventricular fibrillation or pulseless ventricular tachycardia.(b)
Classification. Class III (premarket approval)(c)
Date PMA or notice of completion of PDP is required. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED that was in commercial distribution before May 28, 1976. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976. Any other AED and AED accessory described in paragraph (a), shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.