The AutoPulse Resuscitation System Model 100 is intended to be used as an adjunct to manual CPR, on adult patients only, in cases of clinical death as defined by lack of spontaneous breathing and pulse.

Device Description

AutoPulse Resuscitation System Model 100 ("Device") is an automated, portable, battery powered device that compresses the chest of an adult human as an adjunct to manual CPR. The Device consists of a single use chest compression assembly (CCA) that includes a patient liner, and a reusable platform that contains a user control panel, a drive mechanism, a control system, and a power system (rechargeable battery).

AI/ML Overview

The provided text describes the AutoPulse™ Resuscitation System Model 100, an automatic mechanical chest compressor. However, the document does not contain specific acceptance criteria or study details in the format requested. It states that "Appropriate product testing was conducted to evaluate conformance to product specification and substantial equivalence to the predicate device" and that "Testing of the device modifications demonstrates the device meets and improves upon the predicate device." This indicates that internal testing was performed, but no details about the methodology, results, or specific criteria are provided.

Therefore, many of the requested fields cannot be populated based on the given information.

Here's an analysis of what can be inferred or what is explicitly missing:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not specified in this document	"meets and improves upon the predicate device"

2. Sample size used for the test set and the data provenance

Sample Size: Not specified.
Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The document only mentions "product testing was conducted."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable; the testing described is for device conformance and substantial equivalence, not a ground truth establishment by experts for diagnostic or interpretative performance.

4. Adjudication method for the test set

Not applicable; the testing described is for device conformance and substantial equivalence.

5. 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

Not applicable. This device is a mechanical chest compressor, not an AI diagnostic imaging device that would involve human reader interpretation.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

The device operates as a standalone mechanical chest compressor, but this question typically refers to the "standalone performance" of an AI algorithm's diagnostic accuracy. The document does not describe such a study for this device.

7. The type of ground truth used

The document implies that the "ground truth" for its performance would be its ability to perform mechanical chest compressions according to its specifications and "substantially equivalent" to (or improved upon) its predicate device. No external "ground truth" like pathology or outcomes data is mentioned in relation to specific performance metrics for the device itself in this summary.

8. The sample size for the training set

Not applicable. This device is a mechanical system, not an AI algorithm requiring a training set.

9. How the ground truth for the training set was established

Not applicable.

Conclusion:

The provided 510(k) summary focuses on general device description, intended use, predicate device comparison, and regulatory status. It states that testing was conducted to demonstrate conformance and substantial equivalence but does not provide details about the specific acceptance criteria, study design, sample sizes, or performance metrics that would answer the posed questions. The questions are largely tailored to AI/diagnostic devices, which this medical device (a mechanical chest compressor) is not.

Summary

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Ka3602

510(k) Summary

General Information

DEC 21 200
Classification	Class III
Trade Name	AutoPulse™ Resuscitation System Model 100
Common Name	Automatic Mechanical Chest Compressor
Classification Name	External Cardiac Compressor 870.5200
Submitter	ZOLL Circulation249 Humboldt CourtSunnyvale, CA 94089
	Phone: 408-541-2140Fax: 408-514-1030
Contact	Mark PerkinsDirector, Quality Assurance and Regulatory Affairs
Date Prepared	October xx, 2006

Intended Use

Predicate Devices

AutoPulse™ Resuscitation System Model 100 K040453

Device Description

Materials

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All materials used in the manufacture of the AutoPulse Resuscitation System Model 100 are suitable for this use and have been used in numerous previously cleared products.

Testing:

Appropriate product testing was conducted to evaluate conformance to product specification and substantial equivalence to the predicate device. Testing of the device modifications demonstrates the device meets and improves upon the predicate device.

Summary of Substantially Equivalence:

The AutoPulse Resuscitation System Model 100 is equivalent to the predicate device. The indications for use, basic overall function, and materials used have been determined to be substantially equivalent.

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Public Health Service

Image /page/2/Picture/2 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 wing-like shapes. The bird is positioned above a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 1 2006

ZOLL Circulation c/o Mr. Mark Perkins Director, Quality Assurance and Regulatory Affairs 249 Humboldt Court Sunnyvale, CA 94089

Re: K063602 AutoPulse™ Resuscitation System Model 100 Regulation Number: 21 CFR 870.5200 Regulation Name: External Cardiac Compressor Regulatory Class: III Product Code: DRM Dated: December 1, 2006 Received: December 5, 2006

Dear Mr. Perkins:

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. Mark Perkins

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), please contact the Office of Compliance at (240) 276-0120. 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,

B. Zimmerman for

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):	This Application
Device Name:	AutoPulse TM Resuscitation System Model 100
Indications For Use:	The AutoPulse Resuscitation System Model 100 isintended to be used as an adjunct to manual CPR, on adultpatients only, in cases of clinical death as defined by lackof spontaneous breathing and pulse.

Prescription Use _X

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(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)

のお気になる。

Blymmman

(Division Sign-Off) Division of Cardiovascular Devices 510(k) Number_K063602

Regulation Number and Section

§ 870.5200 External cardiac compressor.

(a)
Identification. An external cardiac compressor is an externally applied prescription device that is electrically, pneumatically, or manually powered and is used to compress the chest periodically in the region of the heart to provide blood flow during cardiac arrest. External cardiac compressor devices are used as an adjunct to manual cardiopulmonary resuscitation (CPR) when effective manual CPR is not possible (e.g., during patient transport or extended CPR when fatigue may prohibit the delivery of effective/consistent compressions to the victim, or when insufficient EMS personnel are available to provide effective CPR).(b)
Classification. Class II (special controls). The special controls for this device are:(1) Nonclinical performance testing under simulated physiological conditions must demonstrate the reliability of the delivery of specific compression depth and rate over the intended duration of use.
(2) Labeling must include the following:
(i) The clinical training necessary for the safe use of this device;
(ii) Adjunctive use only indication prominently displayed on labels physically placed on the device and in any device manuals or other labeling;
(iii) Information on the patient population for which the device has been demonstrated to be effective (including patient size and/or age limitations,
e.g., adult, pediatric and/or infant); and(iv) Information on the time necessary to deploy the device as demonstrated in the performance testing.
(3) For devices that incorporate electrical components, appropriate analysis and testing must demonstrate that the device is electrically safe and electromagnetically compatible in its intended use environment.
(4) Human factors testing and analysis must validate that the device design and labeling are sufficient for effective use by the intended user, including an evaluation for the time necessary to deploy the device.
(5) For devices containing software, software verification, validation, and hazard analysis must be performed.
(6) Components of the device that come into human contact must be demonstrated to be biocompatible.