Unconscious .
Not breathing .
Without circulation .
The Samaritan® AED is intended for use by personnel who have been trained in its operation. Users should have received training in basic life support / AED, advanced life support or a physician-authorized emergency medical response training program. The Samaritan® AED is not currently indicated for use on children less than 8 years old.

Device Description

The HeartSine Samaritan® AED is a small, portable, battery operated automated external defibrillator (AED) designed to treat victims of a cardiac arrest. The Samaritan® incorporates a simple user interface of voice prompts and text prompts to guide the user. A proprietary ECG analysis algorithm automatically renders a shock or no-shock decision. If a shock is required, the Samaritan® will automatically charge to the appropriate energy level and prompts the user to press an illuminated shock button - to deliver the therapeutic energy to the patient. A low energy, escalating truncated exponential biphasic waveform pulse is delivered. A 100 Joule, 150 Joule, 200 Joule escalating energy sequence is used. After three consecutive shocks have been administered, the Samaritan® will pause 60 seconds to allow cardiopulmonary resuscitation to be performed. The Samaritan® AED uses two non-sterile, single use, self-adhesive, conductive adhesive gelled defibrillation/monitoring electrodes to obtain the patient's ECG rhythm and, if required, deliver the defibrillation pulse to the patient.
The Samaritan® AED incorporates the following features:

. Backlight LCD display providing text prompts and ECG display
Manual override capability to allow manual charging of biphasic energies . of 100 J, 150 J, 200 J or 230 J.
Automated self tests with a separate status indicator display .
. Controls for Power On/Off, Shock, Backlight, Contrast & manual override
Integral event data recording incorporated in the removable battery .
A non-rechargeable lithium manganese dioxide battery will operate the Samaritan® AED for 12 hours of continuous ECG monitoring or provide 120 - 200 Joule shocks. The battery also incorporates a memory chip to allow event and incident documentation. 12 hours of continuous ECG as well as incident events time stamped and 60 minutes of audio can be recorded to the battery for post incident review.

AI/ML Overview

Here's an analysis of the provided text regarding the HeartSine Samaritan® AED, structured to answer your questions about acceptance criteria and the study proving it:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly list quantitative acceptance criteria in a table format. Instead, it states that the device complies with industry standards. The reported performance is framed in terms of this compliance.

Acceptance Criterion (Implied from Standards)	Reported Device Performance
Compliance with ANSI/AAMI DF2-1996 (Cardiac Defibrillator Devices)	"These data demonstrate that the Samaritan® AED complies with the applicable sections of ANSI / AAMI DF2- 1996 (Cardiac Defibrillator Devices)"
Compliance with ANSI/AAMI DF39-1993 (Automatic External Defibrillators & Remote Controlled Defibrillators)	"and ANSI / AAMI DF39 - 1993 Automatic External Defibrillators & Remote Controlled Defibrillators."
Efficacy of Biphasic Waveform	"The efficacy of the biphasic waveform in this device has been demonstrated in animal and human clinical trials."
Substantial Equivalence to Predicate Device	"The information in this 510(k) submission demonstrates that the HeartSine Samaritan® AED is substantially equivalent to the predicate device with respect to safety. effectiveness and performance."

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

The provided document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective) for the "animal and human clinical trials" mentioned.

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

The document does not specify the number of experts used or their qualifications for establishing ground truth in any clinical trials.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method used for the test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, nor does it quantify any effect size of human readers improving with or without AI assistance. The device is an AED, which is primarily an automated diagnostic and therapeutic device, rather than an AI-assisted diagnostic tool for human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, a standalone performance assessment was conducted for the device's core function. The document states: "A proprietary ECG analysis algorithm automatically renders a shock or no-shock decision." This implies that the algorithm performs its analysis and makes a decision independently. The overall device then guides the user to press a shock button if a shock is indicated, but the initial "shock or no-shock decision" is algorithmic.

7. The Type of Ground Truth Used

The document refers to "animal and human clinical trials" to demonstrate the efficacy of the biphasic waveform. For AEDs, the ground truth for efficacy would typically be:

Clinical Outcomes Data: Such as successful defibrillation, return of spontaneous circulation (ROSC), and patient survival, observed in human trials.
Physiological Response Data: In animal trials, this would involve observing the cessation of ventricular fibrillation and return to a perfusing rhythm.

For the shock/no-shock decision, the ground truth would typically be:

Expert Consensus on ECG Interpretation: A panel of cardiologists or electrophysiologists independently reviewing ECGs and determining the presence or absence of a shockable rhythm (e.g., ventricular fibrillation, pulseless ventricular tachycardia). This is inferred, not explicitly stated in this document.

8. The Sample Size for the Training Set

The document does not specify the sample size used for the training set for the "proprietary ECG analysis algorithm."

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

The document does not explicitly state how the ground truth for the training set was established. However, for an ECG analysis algorithm in an AED, it would typically involve:

Annotated ECG Databases: Large databases of ECG recordings from patients in cardiac arrest, with each recording meticulously labeled by expert cardiologists or electrophysiologists as either a shockable rhythm (e.g., VF, pulseless VT) or a non-shockable rhythm (e.g., asystole, PEA, normal sinus rhythm).

Summary

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510(k) Summary

Date Summary Prepared:

K023854

November 15, 2002

Submitter's Name and Address:

HeartSine Technologies, Inc. 25892 Jamon Lane Mission Viejo, CA 92691

Contact Person:

William J. Smirles, EMT-P Telephone: 1.847.317.0926 Facsimile: 1.517.809.6748

Device Name:

Proprietary Name: HeartSine Samaritan® AED Common Name: Automated External Defibrillator Classification Names: DC-Defibrillator, Low Energy

Predicate Device:

The features and functions of the HeartSine Samaritan® AED are substantially equivalent to those of the Phillips Heartstream FR2 (K003565).

Device Description:

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The Samaritan® AED incorporates the following features:

. Backlight LCD display providing text prompts and ECG display
Manual override capability to allow manual charging of biphasic energies . of 100 J, 150 J, 200 J or 230 J.
Automated self tests with a separate status indicator display .
. Controls for Power On/Off, Shock, Backlight, Contrast & manual override
Integral event data recording incorporated in the removable battery .

A non-rechargeable lithium manganese dioxide battery will operate the Samaritan® AED for 12 hours of continuous ECG monitoring or provide 120 - 200 Joule shocks. The battery also incorporates a memory chip to allow event and incident documentation. 12 hours of continuous ECG as well as incident events time stamped and 60 minutes of audio can be recorded to the battery for post incident review.

Indications for Use:

The HeartSine Samaritan® AED is indicated for use on victims of cardiac arrest who are exhibiting the following signs:

. Unconscious
Not breathing .
Without circulation .

The Samaritan® AED is intended for use by personnel who have been trained in its operation. Users should have received training in basic life support / AED, advanced life support or a physician-authorized emergency medical response training program. The Samaritan® AED is not currently indicated for use on children less than 8 years old.

Summary of Performance Information:

Testing and performance documentation has been submitted with the 510(k) submission. These data demonstrate that the Samaritan® AED complies with the applicable sections of ANSI / AAMI DF2- 1996 (Cardiac Defibrillator Devices) and ANSI / AAMI DF39 - 1993 Automatic External Defibrillators & Remote Controlled Defibrillators. The efficacy of the biphasic waveform in this device has been demonstrated in animal and human clinical trials.

The information in this 510(k) submission demonstrates that the HeartSine Samaritan® AED is substantially equivalent to the predicate device with respect to safety. effectiveness and performance.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 4 2003

Heartsine Technologies, Inc. Mr. William J. Smirles Senior Vice President 25892 Jamon Lane Mission Viego, CA 92691

Re: K023854

Trade/Device Name: Samaritan® AED Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia detector and alarm. Regulatory Class: Class III Product Code: MKJ Dated: November 15, 2002 Received: November 19, 2002

Dear Mr. Smirles:

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 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

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Page 2 - Mr. William J. Smirles

forth in the quality systems (OS) 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

Enclosure

1 11 11

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Section

Indications for Use

510(k) Number (if known):

KO23854

Device Name: HeartSine Technologies, Inc. Samaritan® AED

Indications for Use: The HeartSine Samaritan® AED is indicated for use on victims of cardiac arrest who are exhibiting the following signs:

Unconscious .
Not breathing .
Without circulation .

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

510(k) Num

Prescription Use:

Over-the-Counter Use: or

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.