The Powerheart® AED G3 family of devices 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 ECG rhythm. If a shockable ventricular tachyarrhythmia recurs, the device will change automatically and advise the operator to deliver therapy (G3) or automatically deliver the charge (G3 Automatic).

When the patient is a child or infant up to 8 years of age, or up to 55 lbs (25kg), the device 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.

Additional information exclusive to the Powerheart® AED G3 Pro, Model 9300P:

At the discretion of emergency care personnel, the G3Pro with ECG display enabled can also be used with Model 5111 ECG Patient Cable to display the rhythm of a responsive or breathing patient, regardless of age. The G3Pro and ECG Patient Cable system provides a non-diagnostic display for attended patient monitoring. While connected the G3Pro ECG Patient Cable, the G3Pro evaluates the patient's ECG and disables its shock capability.

Device Description

The Powerheart® AED G3 family of devices (Model numbers 9300A/E, model numbers 9390A/E, and model number 9300P) are portable, battery operated, automatic or semi-automatic, automated external defibrillators (AED). After applying the AED electrodes (pads) to the patient's bare chest, the AED automatically analyzes the patient's electrocardiogram (EGG) and guides the operator through the rescue using a combination of voice prompts, audible alerts, and visible indicators. For the Powerheart® AED G3 Automatic, the AED automatically delivers a shock if needed. For the Powerheart® AED G3 Semi-automatic, the AED uses one button and advises the operator to press the button and deliver a shock if needed.

The Powerheart® AED G3 family of devices includes a periodic automatic self-test feature. The focus of this submission is a software modification to enhance the detection capability of the device self-test feature.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a software modification to existing Powerheart® AED G3 devices. The core of this submission is about enhancing the detection capability of the device's self-test feature, not about a new clinical algorithm for patient diagnosis or treatment. This type of submission typically focuses on functional and performance testing related to the software change rather than a comprehensive clinical study to prove efficacy in an AI context.

Therefore, many of the requested elements for an AI/device performance study (like MRMC studies, sample sizes for training/test sets, expert qualifications, etc.) are not applicable or not provided in this document as it pertains to a software change for a self-test feature in an AED. The document essentially states that the new software has been verified and validated to ensure continued safety and effectiveness, and that it is substantially equivalent to the previously cleared predicate devices.

Here's a breakdown of the information that can be extracted or inferred based on the provided text, and where gaps exist:

Acceptance Criteria and Device Performance

The document does not explicitly state "acceptance criteria" in a table format with specific metrics for the software modification. Instead, it concludes that "software verification and validation testing has been successfully completed for all models of the modified Powerheart® AED G3 family of devices to demonstrate appropriate functional and performance characteristics."

The implicit acceptance criterion for this 510(k) submission is that the modified software maintains the safety and effectiveness of the device and does not raise new questions of safety or effectiveness compared to the predicate device. The "reported device performance" is summarized as "appropriate functional and performance characteristics" being demonstrated.

Given that this is a 510(k) for a software enhancement to a self-test feature, quantitative clinical performance metrics (like sensitivity, specificity for detecting cardiac events) are not the focus of this particular submission. The focus is on the self-test's capability to detect issues.

Study Details

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Implicitly, the software modification must maintain the safety and effectiveness of the device, as demonstrated through successful verification and validation testing, and ensure no new questions of safety or effectiveness are raised compared to the predicate device.
- Reported Device Performance: "Software verification and validation testing has been successfully completed for all models of the modified Powerheart® AED G3 family of devices to demonstrate appropriate functional and performance characteristics."
Sample sizes used for the test set and the data provenance:
- Not explicitly stated in the provided text. The document mentions "software verification and validation testing" but does not detail the specific test cases, sample sizes, or the origin of any data used for these tests. For a self-test software change, this would likely involve internal testing data rather than patient data from specific countries.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not stated. This submission focuses on a software modification for a self-test mechanism, not on a diagnostic algorithm requiring expert-established ground truth from medical images or physiological signals.
Adjudication method for the test set:
- Not applicable/Not stated. As above, no clinical diagnostic "ground truth" relevant to human adjudication appears to be established for this software modification.
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, an MRMC study was not done or reported. This type of study is relevant for AI-powered diagnostic or assistive tools where human performance can be measured and compared with and without AI assistance. This submission describes a modification to a device's self-test feature, which does not involve human readers in an diagnostic capacity in conjunction with an AI.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes (inferred), in the context of the self-test. The core of this submission is a "software modification to enhance the detection capability of the device self-test feature." This implies that the algorithm for the self-test itself operates in a standalone manner to identify potential device malfunctions. The performance of this specific software component would have been evaluated directly. Details on this evaluation are not available beyond the statement of successful completion.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not explicitly stated. For a self-test feature, the "ground truth" would likely be derived from engineering specifications and known failure modes, simulated faulty conditions, or controlled test environments designed to verify the self-test's ability to detect predetermined internal issues. It is not a clinical ground truth like pathology or expert consensus on patient diagnosis.
The sample size for the training set:
- Not applicable/Not stated. This submission describes a software modification to an existing device's self-test, not the development of a new AI algorithm that typically requires a large training set from medical data. If any "training" occurred, it would be in the context of software development and debugging, using internal data or simulated environments, rather than a clinical training set.
How the ground truth for the training set was established:
- Not applicable/Not stated. See point 8.

Summary of Device and Submission Type:
The Powerheart® AED G3 devices are Automated External Defibrillators. This 510(k) submission (K102496) is for a software modification to enhance the detection capability of the device's self-test feature. This is a crucial distinction, as it is not a submission for a new AI diagnostic algorithm or an AI-assisted diagnostic tool for which many of the requested performance metrics would be relevant. The submission primarily asserts substantial equivalence to previously cleared predicate devices based on successful software verification and validation testing, confirming the modified software maintains appropriate functional and performance characteristics and doesn't raise new safety/effectiveness concerns.

Summary

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JUN - 9 2011

510(k) Summary

Submitter's name, address, telephone number, contact person, and data A. summary was prepared
Submitter

Contact Person

Cardiac Science Corporation 3303 Monte Villa Parkway Bothell, WA 98021-8969

Kathleen Roberts Regulatory Affairs Manager Phone: (949) 797-3844 Fax: (949) 797-3801

Date Summary Prepared

March 24, 2011

B. Name of device, including trade name and classification name

Trade/Proprietary Name

Powerheart® AED G3 Semi-Automatic (Model 9300E)

Powerheart® AED G3 Automatic (Model 9300A)

Powerheart® AED G3 Pro (Model 9300P)

Powerheart® AED G3 Plus (Models 9390A and 9390E)

Automated External Defibrillator

Class III, 21CFR 870.5310

Classification Name

Classification Number

Product Code

MKJ

C. Identification of the predicate device or legally marketed devices to which substantial equivalence is being claimed.
Company Device

Cardiac Science Corporation Powerheart® AED G3

Confidential Cardiac Science Corporation March 24, 2011

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DeviceIdentification	ModelNumber	510(k)Number	Date Cleared
Powerheart® AED G3 Semi-Automatic	9300E	K031987	7/30/2003
Powerheart® AED G3 Automatic	9300A	K040438	7/1/2004
Powerheart® AED G3 Pro	9300P	K040637	8/6/2004
Powerheart® AED G3 Plus	9390A/E	K052161	10/21/2005

D. Description of the device

E. Intended use of the device

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Additional information exclusive to the Powerheart® AED G3 Pro, Model 9300P :

F. Functional Tests

Software verification and validation testing has been successfully completed for all models of the modified Powerheart® AED G3 family of devices to demonstrate appropriate functional and performance characteristics.

G. Conclusion

Based on the results of the testing, it is concluded that the modifications to the Powerheart® AED do not raise any new questions regarding the safety or effectiveness as compared with the predicate device. The Cardiac Science Corporation Powerheart® AED G3 family of devices described in this submission is substantially equivalent to the previously cleared Powerheart® AED G3 products in terms of indications for use, features and functions.

There are no technological differences between the predicate devices and the modified devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in capital letters.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

JUN - 9 2011

Cardiac Science Corporation c/o Ms. Kathleen Roberts Regulatory Affairs Manager 3303 Monte Villa Parkway Bothell, WA 98021

Re: K102496

Trade/Device Name: Powerheart AED G3 Models 9300A/E, 9390 A/E, and 9300P Regulation Number: 21 CFR 870.5310 Regulation Name: Automated External Defibrillator Regulatory Class: Class III (three) Product Code: MKJ Dated: May 10, 2011 Received: May 11, 2011

Dear Ms. Roberts:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III(PMA), it may be subject to 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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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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

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

510(k) Number (if known): K1024960

Device Name: Powerheart® AED G3 Model 9300A/E Powerheart® AED G3 Model 9390A/E Powerheart® AED G3 Model 9300P

Indications for Use:

Additional information exclusive to the Powerheart® AED G3 Pro, Model 9300P:

Prescription Use X _ (Part 21 CFR 801 Subpart D)

AND/OR

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

(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

ConfidentialCardiac Science Corporation	510(k) NumberK102496August 27, 2010	510(k) Number	K102496		August 27, 2010	Page 1 of 1Page 11Special 510(k)
510(k) Number	K102496
	August 27, 2010

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.