The Powerheart ECD is indicated for the termination of certain fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. Delivery of energy in the synchronized mode is a method for treating atrial fibrillation, atrial flutter, paroxysmal supraventricular tachycardia, and in relatively stable patients, ventricular tachycardia.

The semi-automatic advisory mode is for use in cardiac arrest in patients of at least 8 years of age. The patient must be unconscious, pulseless, and not breathing spontaneously before using the defibrillator to analyze the patient's ECG rhythm.

The Powerheart ECD 3-lead and 5-lead ECG monitoring allows for identification or interpretation of cardiac rhythms or dysrhythmias and calculation of heart rate.

The Powerheart ECD noninvasive pacing as a therapy is indicated for patients with symptomatic bradycardia or asystole.

The Powerheart ECD pulse oximetry is intended for the continuous external monitoring of arterial oxygen saturation and pulse rate and is indicated for use in any patient who is at risk of developing hypoxemia.

Device Description

The Powerheart® ECD is a defibrillator/monitor/pacemaker intended for use by personnel trained in its operation. The device is lightweight, portable, easy to use and reliable. It incorporates a 320 x 240 transmissive TFT color display for wide viewing angles in all light conditions. The device operates using either an AC power supply or internal rechargeable Li-Ion battery. The device provides continuous ECG monitoring and three types of therapies: defibrillation, cardioversion and external pacing. Defibrillation can be applied manually or semi-automatically. Pacing therapy can be either fixed or demand. The device employs patented RHYTHMx® software which provides ECG rhythm analysis. STAR® Biphasic waveform delivers impedance-compensated energy ranging from 2-270 Joules. Features and options include external paddles, spoons, disposable pads, 3- and 5-lead ECG, pulse oximetry (SpO2), built-in 60 mm thermal printer, internal storage of event history and remote synchronization to bedside monitor.

AI/ML Overview

The provided text does not contain detailed information about the acceptance criteria for a specific device performance study, nor does it describe a study that explicitly proves the device meets such criteria. The document is a 510(k) summary for the Powerheart ECD, and it primarily focuses on establishing substantial equivalence to a predicate device.

However, based on the information provided, here's what can be inferred regarding the functional and safety testing:

Device: Powerheart ECD™

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

The document states: "Representative samples of the device components underwent system, safety and bench testing on both hardware and software to demonstrate appropriate functional and performance characteristics."

Acceptance Criteria (Inferred): Appropriate functional and performance characteristics for hardware and software. Given the nature of a defibrillator, this would implicitly include criteria related to:
- ECG rhythm analysis accuracy (identifying treatable vs. non-treatable rhythms)
- Energy delivery accuracy and safety (joule output, impedance compensation)
- Pacing functionality (rate, capture)
- SpO2 monitoring accuracy (if applicable)
- Usability and user interface performance
- Electrical safety and electromagnetic compatibility (EMC)
- Mechanical integrity and environmental robustness.
Reported Device Performance: The document only states that testing was performed to "demonstrate appropriate functional and performance characteristics" and that based on these results, the device "does not raise any different questions regarding the safety or effectiveness as compared with the predicate device." It does not provide specific performance metrics (e.g., sensitivity, specificity, accuracy percentages) against quantitative 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)

The document mentions "Representative samples of the device components" were used for testing. No specific sample sizes for particular test sets are provided, nor is information about data provenance (country, retrospective/prospective).

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)

This information is not provided in the document. The type of testing described (system, safety, bench testing) typically involves engineering and technical experts for verification, but not clinical experts establishing ground truth in the context of diagnostic accuracy studies (which are usually more relevant for AI/algorithm performance claims).

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

This information is not provided.

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

A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned. The device's "RHYTHMx® software" performs ECG rhythm analysis, but the document does not describe a study involving human readers interacting with or being assisted by this AI for diagnosis or treatment decisions.

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

The document states that the "RHYTHMx® software which provides ECG rhythm analysis" is employed. The "semi-automatic advisory mode" is described as analyzing the patient's ECG rhythm. This implies an algorithm-only (standalone) performance component for rhythm analysis. However, specific standalone performance metrics (e.g., sensitivity, specificity for treatable rhythms) are not provided in this summary. The testing mentioned ("system, safety and bench testing") would likely include assessments of this software's performance, but details are absent.

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

For the software's ECG rhythm analysis, the ground truth would typically be established by expert cardiologists reviewing ECG waveforms and clinical data. However, the document does not specify how ground truth was established for the software's performance during testing. For hardware and safety testing, ground truth often refers to engineering specifications or validated reference measurements.

8. The sample size for the training set

This information is not provided. The document describes general functional and safety testing, not a machine learning model development process with distinct training and test sets.

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

This information is not provided, as details about a training set for a machine learning model are absent.

Summary of what is present in the document:

The provided text from the 510(k) Summary focuses on demonstrating substantial equivalence of the Powerheart ECD to a predicate device (Medtronic Physio-Control LIFEPAK® 20). It broadly states that "Representative samples of the device components underwent system, safety and bench testing on both hardware and software to demonstrate appropriate functional and performance characteristics." The conclusion drawn from these tests is that the device "does not raise any different questions regarding the safety or effectiveness as compared with the predicate device," facilitating its clearance. No specific quantitative acceptance criteria or detailed results of performance studies (e.g., accuracy, sensitivity, specificity, sample sizes, expert qualifications) are included in this summary document. Such details would typically be found in the full 510(k) submission, not necessarily in the public summary.

Summary

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JAN 3 2006

SECTION 2. SUMMARY AND CERTIFICATION

2.1. 510(k) Summary
Submitter:	Cardiac Science, Inc.5474 Feltl RoadMinnetonka, MN 55343
Contact Person:	Kenneth OlsonPhone: (952) 939-2912Fax: (952) 939-4191
Date Prepared:	August 22, 2005
Trade Name:	Powerheart ECD™
Classification Nameand Number:	Automated External DefibrillatorClass III, 21CFR 870.5310
Product Code:	MKJ
Predicate Device(s):	The Powerheart ECD™ manufactured by Cardiac Science, Incis substantially equivalent to Medtronic Physio-ControlLIFEPAK® 20 Defibrillator (K012274).
Device Description:	The Powerheart® ECD is a defibrillator/monitor/pacemakerintended for use by personnel trained in its operation. Thedevice is lightweight, portable, easy to use and reliable. Itincorporates a 320 x 240 transmissive TFT color display forwide viewing angles in all light conditions. The device operatesusing either an AC power supply or internal rechargeable Li-Ionbattery. The device provides continuous ECG monitoring andthree types of therapies: defibrillation, cardioversion andexternal pacing. Defibrillation can be applied manually orsemi-automatically. Pacing therapy can be either fixed ordemand. The device employs patented RHYTHMx® softwarewhich provides ECG rhythm analysis. STAR® Biphasicwaveform delivers impedance-compensated energy rangingfrom 2-270 Joules. Features and options include externalpaddles, spoons, disposable pads, 3- and 5-lead ECG, pulseoximetry (SpO2), built-in 60 mm thermal printer, internalstorage of event history and remote synchronization to bedsidemonitor.
Indications For Use:	The Powerheart ECD defibrillator system is intended to be usedby personnel who have been trained in its operation.The Powerheart ECD is indicated for the termination of certainfatal arrhythmias, such as ventricular fibrillation andsymptomatic ventricular tachycardia. Delivery of energy in thesynchronized mode is a method for treating atrial fibrillation,atrial flutter, paroxysmal supraventricular tachycardia and in

	relatively stable patients, ventricular tachycardia.
	The semi-automatic advisory mode is for use in cardiac arrest inpatients of at least 8 years of age. The patient must beunconscious, pulseless, and not breathing spontaneously beforeusing the defibrillator to analyze the patient's ECG rhythm.
	The Powerheart ECD 3-lead and 5-lead ECG monitoring allowsfor identification or interpretation of cardiac rhythms ordysrhythmias and calculation of heart rate.
	The Powerheart ECD noninvasive pacing as a therapy isindicated for patients with symptomatic bradycardia or asystole.
	The Powerheart ECD pulse oximetry is intended for thecontinuous external monitoring of arterial oxygen saturation andpulse rate and is indicated for use in any patient who is at risk ofdeveloping hypoxemia.
Functional andSafety Testing:	Representative samples of the device components underwentsystem, safety and bench testing on both hardware and softwareto demonstrate appropriate functional and performancecharacteristics.
Conclusion:	Based on the results of the testing described above, it isconcluded that the Powerheart ECD does not raise any differentquestions regarding the safety or effectiveness as comparedwith the predicate device. The Cardiac Science, Inc. PowerheartECD is substantially equivalent to the Medtronic Physio-Control LIFEPAK 20 in terms of indications for use, featuresand functions.

2.1 510(k) Summarv

510(k) Premarket Submission Cardiac Science, Inc.

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2.2. 510(k) Checklist

Traditional 510(k) Premarket Notification Checklist for Class III Device

No.	Item	Included	Location
1	Cover letter clearly identifying submission as"Traditional 510(k)"	Yes	Cover Letter
2	Table of Contents	Yes	TOC
3	Indication for Use	Yes	IFU page
4	Manufacturer name and address	Yes	Section I
5	Contact person, phone number, fax number	Yes	Section 1
6	Device common name and trade name	Yes	Section 1
7	Establishment registration number	Yes	Section 1
8	Device classification and product code	Yes	Section 1
9	510(k) Summary	Yes	Section 2.1
10	Identification of predicate device	Yes	Section 2.1
11	Truthful and Accurate Statement	Yes	Section 2.4
12	Class III Certification and Summary	Yes	Section 2.5
13	Proposed labeling	Yes	Section 3
14	Description of the device	Yes	Section 4
15	Substantial equivalence comparison	Yes	Section 5
16	Performance testing	Yes	Section 6
17	System Hazard Analysis	Yes	Section 6.1
18	Clinical evaluation	Yes	Section 6.6
19	Biocompatibility data	Yes	Section 7
20	Sterilization information	Yes	Section 8
21	Software documentation	Yes	Section 9
22	Compliance with performance standards	Yes	Section 10

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2.3. Premarket Notification Statement

. '

In lieu of a Pre Market Notification Statement, a 510(k) Summary is provided in Section 2.1. of this 510(k) Premarket Notification.

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DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 3 2006

Cardiac Science, Inc. c/o Mr. Kenneth F. Olson Chief Technical Officer 5474 Feltl Road Minnetonka, MN 55343-7982

Re: K052316 Trade Name: Powerheart ECD Regulation Number: 21 CFR 870.5310 Regulation Name: Automated External Defibrillator Regulatory Class: Class III Product Code: MKJ Dated: December 20, 2005 Received: December 21, 2005

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, 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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Page 2 - Mr. Kenneth F. Olson

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 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 (240) 276-0120. 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/industry/support/index.html.

Sincerely vours,

Bheminar for

Bram D. Zuckerman, M.D. Director Division of Cardiovacsular 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: Powerheart ECD TM

The Powerheart ECD defibrillator system is intended to be used by personnel who have been trained in its operation.

The Powerheart ECD 3-lead and 5-lead ECG monitoring allows for identification or interpretation of cardiac rhythms or dysrhythmias and calculation of heart rate.

The Powerheart ECD noninvasive pacing as a therapy is indicated for patients with symptomatic bradycardia or asystole.

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

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page I of l

Blammymer

(Division Sign-Off
Division of Cardiovascular Devices
510(k) Number K052316

510(k) Premarket Submission Cardiac Science, Inc.

Powerheart ECD CONFIDENTIAL

August 23, 2005

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.