The ZOLL AED Plus external defibrillator is intended to be used by personnel who are qualified by training in basic life support, or advanced life support, or other physician authorized emergency medical response to defibrillate victims of cardiac arrest. Use the AED when a suspected cardiac arrest victim has an apparent LACK OF CIRCULATION as indicated by:

Unconsciousness and .
Absence of normal breathing and ●
Absence of a pulse or signs of circulation .

When a victim is a child or infant less than 8 years of age, or less than 55 lbs (25kg), the ZOLL AED Plus should be used with the ZOLL AED Plus Pediatric Electrodes. Therapy should not be delayed to determine the patient's exact age or weight.

Device Description

The ZOLL AED Plus is a lightweight, portable, battery-powered semi-automatic external defibrillator that utilizes the ZOLL Rectilinear Bi-Phasic defibrillation waveform to guide a user through a cardiac arrest rescue. The device is designed to be used by trained emergency responders for the treatment of cardiac arrest.

When connected with ZOLL AED Plus defibrillation electrodes to a patient, the device will analyze the electrocardiographic (ECG) rhythm of the patient and detect whether the rhythm is shockable or non-shockable. If the device detects a shockable rhythm, the device charges the capacitor, enables the "Shock Button", and issues the warning "Don't Touch Patient". The user can then press the treatment button to deliver defibrillation therapy to the patient. If the patient is not in a shockable rhythm, CPR may be advised and administered after automatically repeated analyses of the patient's heart rhythm.

The ZOLL AED Plus is lightweight. It can easily be transported to any rescue site. It is rugged and ready to use at a moment's notice. The device automatically performes a periodic self-test and continually indicates its state of readiness to the user.

When the ZOLL AED Plus is used in conjunction with the ZOLL AED Plus Pediatric Electrodes, the device can be used on patients less than 8 years of age. Labeling and packaging of the electrodes is designed to promote a clear visual distinction between adult and pediatric electrodes.

AI/ML Overview

Here's an analysis of the provided text regarding the ZOLL AED Plus (V5.32 Software Release) and its FDA 510(k) clearance (K091561), focusing on acceptance criteria and study details.

It's important to note that the provided 510(k) summary does not contain detailed performance criteria or a standalone study proving the device meets specific acceptance criteria in the way a typical AI/software device submission would today. This 510(k) clearance is from 2010 for a software update to an existing AED, and the focus is on demonstrating "substantial equivalence" to the previously cleared version, rather than setting and meeting new, quantitative performance objectives.

However, I will extract the information available and highlight where specific details you requested are not present in the document.

Acceptance Criteria and Device Performance

Acceptance Criteria Category	Specific Criteria (Implicit/Explicit)	Reported Device Performance
Functional Equivalence	Device performs as well as the indicated predicate device.	"Extensive performance testing ensures that the ZOLL AED Plus (with software version 5.32) performs as well as the indicated predicated predicate device and meets all of its functional requirements and performance specifications."
Safety Equivalence	Device complies with applicable sections of recognized industry and safety standards.	"Safety testing assures that the device complies with applicable sections of recognized industry and safety standards."
Performance Specifications	Meets all functional requirements and performance specifications (of the predicate).	"Extensive performance testing ensures that the ZOLL AED Plus (with software version 5.32) ... meets all of its functional requirements and performance specifications."
Pacing/Defibrillation Therapy	Delivers appropriate defibrillation therapy when a shockable rhythm is detected.	"If the device detects a shockable rhythm, the rhythm is classified as 'shockable' or 'non-shockable.' If the device detects a shockable rhythm, the device charges the capacitor, enables the 'Shock Button.' The user can then press the treatment button to deliver defibrillation therapy to the patient." (Describes functionality, but no quantitative performance metric provided for detection accuracy or treatment delivery success rates.)
Pediatric Use	Functions correctly with pediatric electrodes for patients less than 8 years of age or less than 55 lbs (25kg).	"When the ZOLL AED Plus is used in conjunction with the ZOLL AED Plus Pediatric Electrodes, the device can be used on patients less than 8 years of age. Labeling and packaging of the electrodes is designed to promote a clear visual distinction between adult and pediatric electrodes." (Describes intended use and distinction, but no specific performance criteria for pediatric detection/therapy.)
Self-Test/Readiness	Performs periodic self-tests and indicates readiness.	"The device automatically performes a periodic self-test and continually indicates its state of readiness to the user."

Study Details

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated. The document refers to "extensive performance testing" but does not provide details on the sample size of cases or patients used for this testing.
- Data Provenance: Not explicitly stated. The document doesn't specify the country of origin of the data, nor whether the data was retrospective or prospective. Given the nature of AED testing, it likely involves simulated cardiac rhythms and possibly animal or human subject testing under controlled conditions, but no specifics are provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable/Not mentioned. For an AED's rhythm analysis, ground truth is typically established based on well-defined ECG characteristics and established medical standards for shockable vs. non-shockable rhythms, rather than expert consensus on individual cases. The document does not describe human experts establishing ground truth for a test set in the context of rhythm analysis.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Adjudication Method: Not applicable/Not mentioned. As the ground truth is likely based on objective ECG criteria and a "gold standard" for rhythm classification in AEDs, a human adjudication process for individual cases (like 2+1 or 3+1 for imaging datasets) is not typically performed or described for this type of device.
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:
- MRMC Study: No. This device is an automated external defibrillator; its primary function is to analyze ECG and deliver shocks independently, guiding a human user rather than assisting a human "reader" in making a diagnostic decision in the same way an AI for medical imaging would. The "human readers" in this context (trained emergency responders) are following explicit device instructions (e.g., "Press Shock Button") rather than interpreting data with AI assistance. Therefore, an MRMC study comparing human reader performance with and without this AI (algorithm) assistance is not relevant to this device's function and was not performed or described.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Yes, implicitly. The core function of the AED, specifically its rhythm analysis (detecting "shockable" or "non-shockable" rhythms), is a standalone algorithm operation. The document states: "the device will analyze the electrocardiographic (ECG) rhythm of the patient and detect whether the rhythm is shockable or non-shockable." This analysis is performed by the algorithm (software version 5.32) without human intervention in the analysis process itself. The human-in-the-loop aspect comes from the user pressing the shock button after the device has made its determination and verbalized instructions. However, no specific performance metrics (e.g., sensitivity, specificity for shockable rhythm detection) are provided for this standalone algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: Implicitly, established medical standards and objective ECG interpretations. For rhythm analysis in AEDs, the ground truth for what constitutes a "shockable" rhythm (e.g., Ventricular Fibrillation, Pulseless Ventricular Tachycardia) is based on universally accepted electrocardiographic criteria and international resuscitation guidelines. This is not typically "expert consensus" on specific cases but rather adherence to predefined diagnostic criteria.
The sample size for the training set:
- Training Set Sample Size: Not applicable/Not mentioned. This document describes a software update (V5.32) to an existing AED for "substantial equivalence." While the original development of an AED's rhythm analysis algorithm would have involved training data, this specific 510(k) does not mention a training set or its size. The focus is on demonstrating that the updated software performs equivalently and safely to the predicate device, not on validating a newly developed AI model from scratch.
How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable/Not mentioned. Similar to point 7, this information is typically relevant for initial algorithm development. For a software update demonstrating substantial equivalence, the specific details of the original training set ground truth establishment are not typically re-evaluated or documented in the 510(k) summary. It would have been based on established ECG classification standards and medical guidelines.

Summary of Limitations in the Document:

The provided 510(k) summary for the ZOLL AED Plus (V5.32) is primarily focused on demonstrating "substantial equivalence" to a previously cleared predicate device (K033474 from 2005) following a software update. As such, it highlights functional and safety equivalence rather than presenting new, detailed performance studies with quantitative acceptance criteria, extensive test sets, or ground truth establishment methods typical of a novel AI device submission. The FDA clearance is based on the assertion that the updated device performs "as well as" and meets the "functional requirements and performance specifications" of the legally marketed predicate device, without detailing those specific metrics for the updated device in this summary.

Summary

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૪૯9156

510(k) Summary:

SEP 2 3 2010

Submitter's Name and Address:

ZOLL Medical Corporation 269 Mill Road Chelmsford, MA 01824-4105 (978) 421-9655

Contact Person:

Charles W. Kolifrath (978) 421-9786

Date Summary Prepared:

May 22, 2009

Device:

ZOLL AED Plus (V5.32 Software Release)

Classification:

Automatic External Defibrillators: Class III (21 CFR 870.5310) Cardiopulmonary Resuscitation Aid: Class III (21 CFR 870.5200)

Description:

The ZOLL AED Plus is a lightweight, portable, battery-powered semi-automatic external The ZOLL AED Fids is a lightwolght, portually cons to guide a user through a cardiac ochbhilator that about willized the ZOLL Rectilinear Bi-Phasic defibrillation arrest reseat. The device is designed to be used by trained emergency responders for the treatment of cardiac arrest.

When connected with ZOLL AED Plus defibrillation electrodes to a patient, the device will analyze the electrocardiographic (ECG) rhythm of the patient and detect whether the will analyze the clestroomale. If the device detects a shockable rhythm, the rifythin is shockable of non onbonable." device charges the oupdoiter, chables in the ment Button". The user can then press the warning "Dort Frodor Fration," Toution therapy to the patient. If the patient is not treathent button to dolliver donamalism may be advised and administered after automatically repeated analyses of the patient's heart rhythm.

The ZOLL AED Plus is lightweight. It can easily be transported to any rescue site. It is The ZOLL AED Plus is lightweight. Tt our outly bo transported in and ready to use at a

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K091561 pg 2 of 2

moment's notice. The device automatically performes a periodic self-test and continually indicates its state of readiness to the user.

Intended Use:

The ZOLL AED Plus external defibrillator is intended to be used by personnel who are qualified by training in basic life support, or advanced life support, or other physicianauthorized emergency medical response to defibrillate victims of cardiac arrest.

Use the AED when a suspected cardiac arrest victim has an apparent LACK OF CIRCULATION as indicated by:

Unconsciousness and .
Absence of normal breathing and .
Absence of a pulse or signs of circulation ●

Substantial Equivalence:

The features and functions of the proposed ZOLL AED Plus (with software version 5.32) are substantially equivalent to the currently marketed ZOLL AED Plus (K033474, cleared for use on 4/7/2005).

Comparison of Technological Characteristics

The technological characteristics of the proposed ZOLL AED Plus (with software version 5.32) are substantially equivalent to the currently marketed ZOLL AED Plus (K033474, cleared for use on 4/7/2005).

Performance Testing:

Extensive performance testing ensures that the ZOLL AED Plus (with software version 5.32) performs as well as the indicated predicated predicate device and meets all of its functional requirements and performance specifications. Safety testing assures that the device complies with applicable sections of recognized industry and safety standards.

Conclusion

Performance and safety testing of the ZOLL AED Plus (with software version 1 enomance and bullety tooling on the functions are substantially equivalent to 5.02) domonotices the indicated commercially distributed predicate device with regard to performance, safety and effectiveness.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized representation of a bird or eagle in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the emblem.

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

Zoll Medical Corporation c/o Mr. Charles W. Kolifrath Regulatory Affairs Manager 269 Mill Road Chelmsford, MA 01824

SEP 2 3 2010

Re: K091561

Trade/Device Name: Zoll AED Plus Defibrillator Regulation Number: 21 CFR 870.5310 Regulation Name: Automated External Defibrillator Regulatory Class: Class III (three) Product Code: MKJ Dated: September 3, 2010 Received: September 8, 2010

Dear Mr. Kolifrath:

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.

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Page 2 - Mr. Charles W. Kolifrath

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.

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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

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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K09 1561 as.1 ofl

Indications for Use

510(k) Number (if known):

2 3 2010 SEP

Device Name: ZOLL AED Plus

Indications For Use:

Unconsciousness and .
Absence of normal breathing and ●
Absence of a pulse or signs of circulation .

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K091561

Page 1 of

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.