The DDP-100 defibrillation pads are used in conjunction with the Defibtech Sentry semiautomatic external defibrillator and act as a conductive interface between the Sentry and the patient's skin. The disposable electrodes are non-sterile and for single patient use only. The pads are intended for external defibrillation and ECG monitoring in combination with a Defibtech defibrillator.

Device Description

The Sentry is a semiautomatic external defibrillator (AED) designed to be portable and battery powered. It has only two user controls: the ON/OFF and SHOCK buttons. Voice prompts and visual indicators provide a simple interface for the operator. The Sentry AED is capable of recording event information including ECG, audio data (optional) and SHOCK/NO SHOCK recommendations.

When connected to a patient who is unconscious and not breathing the Sentry AED performs the following tasks:

. Prompts the operator to take necessary actions to enable analysis
Automatically analyzes the patient's ECG ●
Determines whether a shockable rhythm is present ●
Charges the defibrillation capacitor if the rhythm is shockable .
. Arms the SHOCK button and prompts the operator to press the SHOCK button when the device is ready and a shock is recommended
Delivers a shock if the user presses the SHOCK button and the device has . determined that a shock is required

The Sentry AED will NOT shock a patient automatically; it will only advise the operator. The SHOCK button is only enabled when a shockable rhythm is detected and the device is charged and ready to shock. Charging occurs automatically when the device detects a shockable rhythm. The operator must press the SHOCK button to initiate deffbrillation.

The Sentry AED uses two non-sterile self-adhesive defibrillation/monitoring pads to monitor ECG signals and, if necessary, to deliver defibrillation energy to the patient. These pads (also known as electrodes) are provided as a single patient use, packaged, disposable assembly.

The Sentry AED determines proper pad-to-patient contact by monitoring the impedance between the two pads. Visual and audio prompts inform the operator of possible problems with patient contact. Voice prompts and visual indicators communicate the status of the AED and of the patient to the operator. The Sentry AED has two pushbutton controls and several LED indicators.

Defibrillation energy is delivered as a biphasic truncated exponential waveform. The device delivers 150 Joules into a 50-ohm load. Energy delivered does not change significantly with patient impedance. although the duration of the generated waveform will vary. The Defibtech AED is designed to deliver up to 150J of defibrillation energy through a patient impedance range of 25 - 150 ohms.

Defibrillation and AED operating power is supplied by a replaceable (non-rechargeable) Lithium/Manganese Dioxide Battery Pack. Battery Packs are available in several configurations that are optimized for use in specific applications. Each Pack is marked with an expiration date.

The Sentry AED records event documentation internally and optionally, on Defibtech Data Cards (DDC). The optional DDC enables the AED to record event documentation. and audio, if enabled. Audio recording is available only for units with Defibtech Data Cards installed. Event documentation stored internally can be downloaded onto a DDC for review.

AI/ML Overview

The provided text describes a 510(k) summary for the Defibtech Sentry Semiautomatic External Defibrillator (AED) and its associated defibrillation pads. It details the device description, intended use, and a conclusion summary of safety and effectiveness, including references to performance testing.

However, the provided document does not contain the specific acceptance criteria, reported device performance in a tabular format, or detailed information about a study proving the device meets acceptance criteria. It states that "Performance testing was performed in accordance with established industry standards (ANSI/AAMI DF39 -Automatic external defibrillators and remote-control defibrifikators: 1993) and recommendations (American Heart Association - Automatic External Defibrillators for Public Access Defibrillation: Recommendations for Specifying and Reporting Arrhythmia Analysis Algorithm Performance, Incorporating New Waveforms and Enhancing Safety: October 1996)."

Therefore, I cannot provide the requested information with the level of detail specified in your prompt from the provided text.

Here's what I can extract or infer based on the provided text, while also explicitly stating what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Missing. The document explicitly refers to established industry standards and recommendations (ANSI/AAMI DF39 and AHA recommendations for arrhythmia analysis algorithm performance) for performance testing. However, it does not detail the specific acceptance criteria derived from these standards or the quantitative reported performance of the Defibtech Sentry against these criteria in a table.

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

Missing. The document states "Performance testing was performed," but does not provide any details regarding the sample size of the test set, the type of data used (e.g., retrospective ECG databases, prospective patient data), or the country of origin of the data.

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

Missing. The document mentions "arrhythmia analysis algorithm performance" but does not describe how the ground truth for evaluating this algorithm was established – specifically, it doesn't mention the number or qualifications of experts involved in creating a reference standard for the test set.

4. Adjudication Method for the Test Set:

Missing. No information is provided regarding the adjudication method used to establish the ground truth for the test set (e.g., 2+1, 3+1 consensus, or other methods).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Missing. The document does not describe any MRMC comparative effectiveness study where human readers' performance with and without AI assistance was evaluated. The Sentry AED is a device that advises the operator to shock, but does not provide assistance in interpreting ECGs for human readers in a way that would suggest an MRMC study.

6. Standalone (Algorithm Only) Performance:

Yes, implicitly. The document states, "Automatically analyzes the patient's ECG" and "Determines whether a shockable rhythm is present." This describes the core function of the algorithm operating in a standalone capacity (i.e., without human intervention in the analysis itself, only in the shock delivery). While specific performance metrics (e.g., sensitivity, specificity for shockable rhythms) are not reported, the statement that performance testing was done according to AHA recommendations for "Arrhythmia Analysis Algorithm Performance" strongly implies that the standalone performance of the algorithm was evaluated.

7. Type of Ground Truth Used:

Implicitly expert consensus or a gold standard derived from expert interpretation. Given the reference to "Arrhythmia Analysis Algorithm Performance" and the nature of AEDs, the ground truth for the algorithm's performance would typically involve a set of ECGs where the presence or absence of a shockable rhythm has been definitively classified by a panel of cardiologists or other experts, or by established criteria. However, the document does not explicitly state how the ground truth was established.

8. Sample Size for the Training Set:

Missing. The document does not provide any information about the training set used for the Sentry AED's algorithm, including its sample size.

9. How the Ground Truth for the Training Set was Established:

Missing. Similar to the test set, the document does not describe how the ground truth for any potential training set was established.

Summary of what can be gleaned and what is missing:

The 510(k) summary focuses on the design and function of the AED, its intended use, and its substantial equivalence to predicate devices based on compliance with general industry standards. It lacks the detailed study methodology and explicit performance data that would be required to answer your questions thoroughly. The FDA letter confirms the device's substantial equivalence but does not elaborate on the specific performance study results.

Summary

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510(k) Summary

Date Summary Prepared: June 18, 2002

Establishment RegistrationLocation
Company Name:	Defibtech, LLC
Address 1:	1200 Boston Post Road
Address 2:	Suite 207
City, State, and Zip Code:	Guilford, CT 06437
Contact Information
Name:	Mr. Gintaras Vaisnys
Telephone:	(203) 453-6654 x17
Facsimile:	(203) 453-6657
Trade (Proprietary) Name	Sentry Semiautomatic External Defibrillator
Model Number	Defibtech Sentry
Common Name	DC-Defibrillator, Low Energy
Trade (Proprietary) Name	Defibrillation Pads or Electrodes
Model Number	DDP-100 Defibrillation Pads
Common Name	External Defibrillation Pads

Substantial Equivalence

Model	Manufacturer	510(k) Number
ForeRunner	Heartstream, Inc.	K955628
KDP-60	Katecho, Inc.	K981737

Device Description

When connected to a patient who is unconscious and not breathing the Sentry AED performs the following tasks:

. Prompts the operator to take necessary actions to enable analysis
Automatically analyzes the patient's ECG ●
Determines whether a shockable rhythm is present ●
Charges the defibrillation capacitor if the rhythm is shockable .

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. Arms the SHOCK button and prompts the operator to press the SHOCK button when the device is ready and a shock is recommended
Delivers a shock if the user presses the SHOCK button and the device has . determined that a shock is required

Intended Use

The Sentry AED is indicated for use on victims of sudden cardiac arrest (SCA) when the patient is:

Unconscious and unresponsive .
Not breathing ●
At least eight vears old .

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The Sentry AED must be used by or on the order of a physician.

Conclusion Summary of Safety and Effectiveness

Testing and performance evaluations demonstrate that the safety and effectiveness of the Defibtech Sentry is substantially equivalent to the predicate device. Performance testing was performed in accordance with established industry standards (ANSI/AAMI DF39 -Automatic external defibrillators and remote-control defibrillators: 1993) and recommendations (American Heart Association - Automatic External Defibrillators for Public Access Defibrillation: Recommendations for Specifying and Reporting Arrhythmia Analysis Algorithm Performance, Incorporating New Waveforms and Enhancing Safety: October 1996).

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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 & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or fabric.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 9 2002

Defibtech, LLC c/o Mr. Gintaras Vaisnys 1200 Boston Post Road Suite 207 Guilford, CT 06437

Re: K013896

Sentry Semiautomatic External Defibrillator (AED) Regulation Number: 870.1025 Regulation Name: Automated External Defibrillator Regulatory Class: III (three) Product Code: MKJ Dated: March 20, 2002 Received: March 21, 2002

Dear Mr. Vaisnys:

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. Gintaras Vaisnys

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 and additionally 21 CFR Part 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" (21CFR Part 807.97). 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.

Doug Tull

na-Bea Tillman, Ph.D. Do Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Ver/ 3 - 4/24/96

Page 1 of 1

Applicant: Defibtech, LLC

510(k) Number (if known): K013896

Device Name: Sentry Semiautomatic External Defibrillator ("AED")

Indications For Use:

The Sentry AED is indicated for use on victims of sudden cardiac arrest ("SCA") when the patient is:

Unconscious and unresponsive -
Not breathing -
At least eight years old -

The Sentry AED must be used by or on the order of a physician.

Contraindications For Use:

The Sentry AED should not be used if the patient shows any of the following signs:

Conscious and/or Responsive =
Breathing
Has a detectable pulse
Is younger than eight years old

Refer to Üser's Manual for Operator Training Requirements.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dell

Ivision of Cardiovascular & Respiratory Desviors 801.109)

Gy-45

(Quiz 1B - 1006)

(Optional Format 1-2-96)

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.