The HeartSine Samaritan® PAD PAK defibrillation electrodes are single use, nonsterile, self-adhesive hydrogel pads, intended to be used for ECG monitoring and external defibrillation. The PAD PAK pads are to be used with the Samaritan® PAD Automated External Defibrillator (K041067) on patients of age 8 years and older.

Device Description

The HeartSine Samaritan® PAD PAK pads are single use, non-sterile, hydrogel polymer self-adhesive electrode pads. The Samaritan® PAD PAK pads will be used in conjunction with Samaritan® PAD low energy semi-automatic external defibrillator (AED). The pads are sealed in a pouch to prevent drying out and to maintain their integrity throughout the duration of the shelf life.

AI/ML Overview

The provided text describes the 510(k) summary for the HeartSine Samaritan® PAD PAK Defibrillation Electrodes. It focuses on the device's substantial equivalence to predicate devices and its intended use, rather than presenting detailed acceptance criteria and a specific study proving device performance against those criteria in a format with numerical targets and reported outcomes.

Here's an analysis based on the information provided, highlighting what can be extracted and what is missing for a comprehensive answer to your request:

Acceptance Criteria and Study Details for HeartSine Samaritan® PAD PAK Defibrillation Electrodes

The provided document (510(k) Summary) describes the general performance and biocompatibility testing undertaken for the HeartSine Samaritan® PAD PAK Defibrillation Electrodes, but it does not specify quantitative acceptance criteria or detailed study results in a table format. Instead, it makes general statements about compliance with standards and internal specifications.

Based on the information, the following can be inferred and what is missing is noted:

1. Table of Acceptance Criteria and Reported Device Performance

A specific table with quantitative acceptance criteria and corresponding reported device performance values is not provided in the document. The document states:

"The PAD PAK pads comply with the requirements of AAMI/ANSI DF80. ISO 10993, and FDA Memorandum G95-1, and with HeartSine Technologies, Inc. internal specifications for a single use, ECG monitoring & defibrillation pad."
"The testing of the PAD PAK pads demonstrate that the PAD PAK Pads function as intended."
"The results of the testing have also shown the Samaritan® PAD PAK pads do not raise any new questions of safety or effectiveness."

To create the requested table, one would need to refer to the specific standards (AAMI/ANSI DF80, ISO 10993, FDA Memorandum G95-1) and the manufacturer's internal specifications, which are not detailed in this summary.

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

The document does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective). It only generally mentions "Testing and performance documentation has been submitted with the 510(k) submission."

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable and not provided. The device is an electrode for monitoring and defibrillation, not an interpretative AI device that requires expert ground truth for its core function. Testing would involve electrical performance, biocompatibility, and physical integrity, not diagnostic accuracy based on expert consensus.

4. Adjudication Method for the Test Set

This information is not applicable and not provided for the same reasons as #3.

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

A MRMC comparative effectiveness study is not applicable to this device. This type of study is typically done for diagnostic imaging or interpretation devices where human readers are involved in assessing cases. The device here is an electrode, and its performance would be assessed through technical, electrical, and biological testing, not by comparing human reader performance with and without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This information is not applicable to this device. As an electrode, there is no "algorithm only" performance or "human-in-the-loop" concept in the way it applies to AI-driven diagnostic devices. The device's function is physical and electrical.

7. Type of Ground Truth Used

The concept of "ground truth" as typically applied to diagnostic algorithms (e.g., pathology, outcomes data, expert consensus) is not applicable here. For an electrode, "ground truth" would refer to established electrical measurement standards, biological safety standards, and physical performance specifications. The document states the device complies with AAMI/ANSI DF80, ISO 10993, FDA Memorandum G95-1, and internal specifications. These standards define the "ground truth" for electrical performance, biocompatibility, and physical characteristics.

8. Sample Size for the Training Set

This information is not applicable and not provided. The Samaritan® PAD PAK electrodes are a hardware device, not an AI/ML algorithm that requires a "training set" in the computational sense.

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

This information is not applicable and not provided for the same reasons as #8.

Summary of what can be extracted from the provided text for acceptance criteria and study:

Acceptance Criteria (General): Compliance with AAMI/ANSI DF80, ISO 10993, FDA Memorandum G95-1, and HeartSine Technologies, Inc. internal specifications. The device should "function as intended" and "not raise any new questions of safety or effectiveness."
Study (General): "Testing and performance documentation has been submitted with the 510(k) submission." This testing demonstrated compliance with the aforementioned standards and internal specifications.
Device Function: Single use, non-sterile, self-adhesive hydrogel pads, intended for ECG monitoring and external defibrillation, to be used with the Samaritan® PAD Automated External Defibrillator on patients 8 years and older.

Missing Information:
Crucially, the document lacks the specific quantitative acceptance criteria, the detailed results from the performance and biocompatibility tests, and any sample sizes used for these tests. The 510(k) summary is a high-level overview, not the detailed technical report of the studies themselves.

Summary

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510(k) Summary SEP = 2 2004

Submitter:	HeartSine Technologies, Inc.
	940 Calle Amanecer, Suite E
	San Clemente, CA 92673

Contact: William J. Smirles Senior Vice President, Marketing & Business Development Phone: 847-317-0926 FAX: 517-809-6748

Proposed Device Identification and Classification:

Proprietary Name:	Samaritan® PAD PAK Defibrillation Electrodes
Common Name:	Disposable Polymer (Hydrogel) External Monitoringand Defibrillation Electrode
Classification Nameand Reference:	Automated External Defibrillator$§$ 870.5310
Classification Panel:	Cardiovascular
Product Code:	74 MKJ
Regulatory Class:	III
Performance Standards:	No performance standards have been promulgatedunder Section 514

Predicate Devices

Meridian Technologies, PRIME ECG System (K012414) .
Philips Medical Systems, Onsite AED M5066A with M5071A pads (K020715) .
Katecho, Inc., KDP-60A Adult Defib/Pace Multifunction Electrode (K002806) .

Substantial Equivalence

The HeartSine Samaritan® PAD PAK defibrillation electrodes are substantially equivalent to the Meridian Medical Technologies, PRIME ECG System electrodes for ECG monitoring, previously cleared under 510(k) # K012414. The Samaritan® PAD PAK electrodes are also substantially equivalent to other legally marketed electrodes for semi-automatic low power DC defibrillators, such as the Philips Onsite Defibrillation pads (Philips Model Number M5071A) as described in the 510(k) submission for the Philips Onsite M5066A Automated External Defibrillator (K020715) and the Katecho, Inc. KDP 60A Adult Multifunction Electrodes (K002806). The Philips and Katecho electrodes are designed for ECG monitoring and defibrillation and are intended for use with a semiautomatic, low power DC defibrillator.

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Intended Use

The HeartSine Samaritan® PAD PAK defibrillation electrodes are single use, non-sterile, self-adhesive hydrogel pads, intended to be used for ECG monitoring and external defibrillation. The PAD PAK pads are to be used with the Samaritan® PAD Automated External Defibrillator (K041067) on patients of age 8 years and older.

Device Description

Performance and Biocompatibility Testing

Testing and performance documentation has been submitted with the 510(k) submission. These data demonstrate that the Samaritan® PAD PAK pads comply with applicable FDA quidelines and industry standards. The PAD PAK pads comply with the requirements of AAMI/ANSI DF80. ISO 10993, and FDA Memorandum G95-1, and with HeartSine Technologies, Inc. internal specifications for a single use, ECG monitoring & defibrillation pad. The testing of the PAD PAK pads demonstrate that the PAD PAK Pads function as intended. The results of the testing have also shown the Samaritan® PAD PAK pads do not raise any new questions of safety or effectiveness.

- - - End of 510(k) Summary * * * * *

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Public Health Service

Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

EP = 2 2004

Heartsine Technologies, Inc. c/o William J. Smirles, EMT-P Senior VP, Marketing & Business Development 940 Calle Amanecer, Suite E San Clemente, CA 92673

Re: K042088

Trade name: Samaritan® PAD PAK Defibrillation Electrode, Model Spp-301 Regulation Number: 21 CFR 870.5310 Regulation Name: Automated External Defibrillator Regulatory Class: Class III (three) Product Code: MKJ Dated: July 30, 2004 Received: August 12, 2004

Dear Mr. Smirles:

We have reviewed your Section 510(k) premarket notification of intent to market the device wo nave rovened your be determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to regars and ment date of the Medical Device Amendments, or to conninered province 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 r ou may, diorerore, mains 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 - William J. Smirles, EMT-P

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 or cary I 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 promated 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 it you attire of Compliance at (301) 594-4648. 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 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,

Nih. ho. Ogle
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):

HeartSine Technologies Samaritan® PAD PAK Defibrillation Pads Device Name:

Indications For Use:

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 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
510(k) Number	K042088
Page 1 of	1

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.