The Powerheart® Automatic External Cardioverter Defibrillator (AECD)® system is intended to acquire the electrocardiograph rhythm for the detection of, and to provide treatment for, ventricular tacharrhythmias of in-hospital patients who are at risk of Sudden Cardiac Arrest.

Device Description

The Powerheart Automatic External Cardioverter Defibrillator monitors a patient's cardiac electrical activity and treats ventricular tacharrhythmias. The Powerheart senses the ECG signal using one set of electrodes, and delivers cardioversion and/or defibrillation energy through another set of electrodes. The cardioversion/defibrillation electrodes are positioned on the patient either transchest or anterior-posteriorly . The Powerheart uses a combination of rate and (if programmed by the physician) morphology to determine the presence of shockable arrhythmias.

When a shockable arrhythmia is detected, the system selects the appropriate (i.e., as pre-set by the patient's physician) electrical countershock for delivery attempt restoring normal cardiac rhythm. Should the arrhythmia continue, the Powerheart will proceed with subsequent delivery of energy (as pre-set by the patient's physician) after each additional evaluation and charging period. Depending upon the physician programmed parameters, the Powerheart may deliver a maximum of eight pulse sequences. Then, the Powerheart will deliver no further therapy automatically until 60 seconds of consecutive non-shockable rhythm is presented or the device is reset manually.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Cardiac Science Powerheart® Automatic External Cardioverter Defibrillator (AECD®):

Acceptance Criteria and Device Performance:

The provided 510(k) summary does not explicitly state quantitative acceptance criteria or a detailed table of reported device performance in terms of specific metrics like sensitivity, specificity, or positive/negative predictive values for arrhythmia detection or treatment success rates. Instead, it refers to conformance with applicable voluntary standards and that the device "performs according to its specifications."

The closest the document comes to defining "acceptance criteria" for performance is:

"The Powerheart AECD was mechanically and functionally tested to demonstrate conformance with applicable section of the ANSI/AAMI voluntary standard DF39-1993 for Automatic External Defibrillators and Remote Control Defibrillators, the ANSI/AAMI Standard ES1-1993, Safe Current Limits for Electromedical Apparatus, and UL544."
"The testing demonstrated that the device performs according to its specifications."
"Data from a clinical investigation of the Powerheart AECD demonstrated that the device is able to safely and effectively treat ventricular tacharrhythmias according to the device specifications."

Since specific numerical acceptance criteria (e.g., "sensitivity must be >XX%") are not provided, I cannot create a table with reported device performance against such criteria. The "reported performance" is broad conformance and ability to safely and effectively treat.

Study Details:

Given the lack of specific detail in the provided text, many fields below will be marked as "Not Provided."

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

Acceptance Criteria (Stated or Implied)	Reported Device Performance
Conformance with ANSI/AAMI DF39-1993 (AEDs)	Device performs according to its specifications.
Conformance with ANSI/AAMI ES1-1993 (Safe Current Limits)	Device performs according to its specifications.
Conformance with UL544	Device performs according to its specifications.
Software performs according to specifications (per FDA Reviewer Guidance for CCD)	Software performs according to its specifications.
Able to safely and effectively treat ventricular tachyarrhythmias (clinical investigation)	Device is able to safely and effectively treat ventricular tachyarrhythmias according to device specifications.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size (Test Set): Not Provided. The document mentions "Data from a clinical investigation" but gives no details on the number of patients or cases.
- Data Provenance:
  - Country of Origin: Not Provided.
  - Retrospective/Prospective: Not Provided. It's described as a "clinical investigation," which typically implies prospective data collection, but this is not explicitly stated.
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)
- Not Provided. The document mentions "clinical investigation" but offers no details on ground truth establishment methods or expert involvement.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- 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
- Not Applicable/Not Provided. This device is an Automatic External Cardioverter Defibrillator (AECD), meaning it's primarily an automated device for arrhythmia detection and treatment, not an AI-assisted diagnostic tool for human readers in the typical MRMC study context. The "clinical investigation" would be assessing the device's direct performance, not how it improves human interpretation.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done
- Yes, implicitly. The device is described as "Automatic External Cardioverter Defibrillator," which functions in a standalone manner to detect and treat arrhythmias. The "clinical investigation" assessed the device's ability to "safely and effectively treat ventricular tacharrhythmias," implying standalone performance evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Explicitly Provided. For a defibrillator, the "ground truth" for successful treatment of ventricular tachyarrhythmias would likely be rhythm conversion to a non-shockable rhythm, as assessed by ECG monitoring and patient status. However, the exact methods or criteria are not detailed in the summary. It would fall under "outcomes data" related to rhythm status.
8. The sample size for the training set
- Not Applicable/Not Provided. The term "training set" is typically used for machine learning models. While the device uses "a combination of rate and (if programmed by the physician) morphology to determine the presence of shockable arrhythmias," it's not described as a deep learning or AI model that would require a distinct "training set" in the modern sense. It likely uses rule-based algorithms or traditional signal processing. The "software" was developed and tested to its specifications, but no mention of a traditional machine learning training set.
9. How the ground truth for the training set was established
- Not Applicable/Not Provided (see answer to #8).

Summary

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K970741

SUMMARY OF SAFETY AND EFFECTIVENESS SECTION 21:

This 510(k) summary of safety and effectiveness information is being submitted in OCT 16 1997 accordance with the requirements of SMDA 1990 and CFR 807.92.

SUBMITTER INFORMATION 21.1

a. Company Name:	Cardiac Science, Inc.
b. Company Address:	1176 Main Street, Suite CIrvine, CA 92614
c. Company Phone:	(714) 587-0357
Company facsimile:	(714) 951-7315
d. Contact Person:	Raymond W. CohenPresident and Chief Executive OfficerCardiac Science, Inc.

February 24, 1997

21.2 DEVICE IDENTIFICATION

f. Date Summary Prepared:

a. Trade/Proprietary Name:	Powerheart® Automatic ExternalCardioverter Defibrillator (AECD®)
b. Classification Name:	Automatic External Defibrillator

IDENTIFICATION OF PREDICATE DEVICE 21,3

Company	Device	510(k) No.	Date Cleared
Laerdal	Heartstart 1000	K883341	September 12, 1988

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DEVICE DESCRIPTION 21.4

21.5 SUBSTANTIAL EQUIVALENCE

The Cardiac Science Powerheart AECD is substantially equivalent to other automatic external defibrillators currently in commercial distribution by Laerdal in terms of intended use of achieving a safe and accurate detection and treatment of ventricular tachyarrhythmia of in-hospital patients who are at risk of Sudden Cardiac Arrest.

The fundamental technical characteristics are similar to those of the predicate device and are listed on the comparison chart provided in this 510(k) submission.

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21.6 INTENDED USE

The Powerheart AECD system is intended to acquire the electrocardiograph rhythm for the detection of, and to provide treatment for ventricular tachyarrhythmias of in-hospital patients who are at risk of Sudden Cardiac Arrest.

21.7 TECHNOLOGICAL CHARACTERISTICS

A comparison of the technological characteristics of the predicate and legally marketed device is provided within this submission.

21.8 PERFORMANCE DATA

The Powerheart AECD was mechanically and functionally tested to demonstrate conformance with applicable section of the ANSI/AAMI voluntary standard DF39-1993 for Automatic External Defibrillators and Remote Control Defibrillators, the ANSI/AAMI Standard ES1-1993, Safe Current Limits for Electromedical Apparatus, and UL544. The testing demonstrated that the device performs according to its specifications. Documentation to support this performance evaluation has been provided within this submission.

Software for the Powerheart AECD was developed and tested in compliance with the FDA Reviewer Guidance for Computer Controlled Device. The testing demonstrated that the software performs according to its specifications. Documentation to support this performance evaluation has been provided within this submission.

Data from a clinical investigation of the Powerheart AECD demonstrated that the device is able to safely and effectively treat ventricular tacharrhythmias according to the device specifications. Documentation to support this performance evaluation has been provided within this submission.

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510(K) CHECKLIST 21.9

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

OCT 16 1997

Mr. Raymond W. Cohen President and CEO Cardiac Science, Inc. 1176 Main Street Building "C" Irvine, California 92614

Re : K970741 Powerheart® Automatic External Cardioverter Defibrillator Regulatory Class: III (three) Product Code: 74 MKJ Dated: July 17, 1997 Received: July 18, 1997

Dear Mr. Cohen:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments. You may, therefore, market the device, subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act). The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) 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 895. A and the country of the states substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note:

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Page 2 - Mr. Raymond W. Cohen

this response to your premarket notification submission does not affect any obligation you might have under section 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.

On August 16, 1993 the Final Rule for Device Tracking was published in the Federal Register, pages 43442-43455 (copy Be advised that under Section 519(e) of the Act enclosed) . as amended by the Safe Medical Devices Act of 1990, FDA has identified the above device as a device which requires tracking. Because the device is subject to tracking, you are required to adopt a method of tracking that follows the devices through the distribution chain and then identifies and follows the patients who receive them. The specific requirements of the regulation are found in 21 CFR 821 as described in the August 16, 1993 Federal Register beginning on page 43447.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act, may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or (301) 443-6597, or at its internet address

"http://www.fda.gov/cdrh/dsmamain.html".

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Page 3 - Mr. Raymond W. Cohen

Please be advised that, in the future, FDA may require postmarket surveillance of this device under the authorities granted under section 522 of the Federal Food, Drug and This issue is currently under consideration by Cosmetic Act. FDA and you will be notified of our decision in writing.

Sincerely yours,

DA Spyl
Thomas J. Callahan, Ph.D.

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosures

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INDICATION FOR USE

510(k) Number:	To Be Assigned By FDA
Device Name:	Powerheart® Automatic External Cardioverter Defibrillator(AECD)®
Indications For Use:	The Powerheart® Automatic External CardioverterDefibrillator (AECD)® system is intended to acquire theelectrocardiograph rhythm for the detection of, and to providetreatment for, ventricular tacharrhythmias of in-hospitalpatients who are at risk of Sudden Cardiac Arrest.

(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, Respiratory,
and Neurological Devices
510(k) Number	K970741

Prescription Use _____________________________________________________________________________________________________________________

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Per 21 CFR 801.109)

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.