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 a 510(k) submission for the AutoPulse™ Resuscitation System Model 100, which is an automated chest compression device. However, it does not contain the detailed information required to answer the specific questions about acceptance criteria and a study proving device performance as requested.

The document states:

"Appropriate product testing was conducted to evaluate conformance to product specification and substantial equivalence to predicate devices." (Page 1, "Testing" section)
"The AutoPulse Resuscitation System Model 100 is equivalent to the predicate products. The indications for use, basic overall function, and materials used are substantially equivalent." (Page 1, "Summary of Substantial Equivalence" section)

This indicates that some testing was performed to demonstrate substantial equivalence to predicate devices (Thumper™ Model 1005, K011046, and K022345), but the specifics of what those tests were, what the acceptance criteria were, and what the reported performance was are not included in this document.

Therefore, I cannot populate the table or answer most of the follow-up questions from the provided text.

Here's what I can extract and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not provided in the document. The document only states that "appropriate product testing was conducted to evaluate conformance to product specification and substantial equivalence." No specific performance metrics, thresholds, or results are detailed.	Not provided in the document.

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).

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

Number of experts: Not specified.
Qualifications of experts: Not specified.

4. Adjudication method for the test set

Adjudication method: Not specified.

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

MRMC study: Not specified. This device is an automated chest compressor, not an AI-assisted diagnostic tool, so an MRMC study in the context of "human readers" is unlikely to be relevant here.

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

This device is inherently "standalone" in its operation as an automated chest compressor, but no specific study reporting its standalone performance metrics are provided in this document. The term "algorithm only" might not directly apply in the same way it would to a diagnostic AI, but the device's mechanical performance would be its standalone metric.

7. The type of ground truth used

Type of ground truth: Not specified. For a resuscitation system, ground truth would typically relate to physiological parameters (e.g., blood flow, chest compression depth/rate) or clinical outcomes, but this is not detailed.

8. The sample size for the training set

Sample size: Not specified.

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

Ground truth establishment: Not specified.

Summary

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K032852

NOV 1 2 2003

510(k) Summary

General Information

Classification	Class III
Trade Name	AutoPulse™ Resuscitation System Model 100
Submitter	Revivant Corporation
	775 Palomar Avenue
	Sunnyvale, CA 94085
	408-524-3500
Contact	Bob H. Katz
	Vice President, Operations

Intended Use

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.

Predicate Devices

K851139	Thumper™ Model 1005
K011046	AutoPulse™ Resuscitation System Model 100
K022345	AutoPulse™ Resuscitation System Model 100

Device Description

Materials

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.

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Testing

Appropriate product testing was conducted to evaluate conformance to product specification and substantial equivalence to predicate devices.

Summary of Substantial Equivalence

The AutoPulse Resuscitation System Model 100 is equivalent to the predicate products. The indications for use, basic overall function, and materials used are substantially equivalent.

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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines above them that resemble wings or feathers.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 2 2003

Mr. Bob H. Katz Vice President, Operations Revivant Corporation 775 Palomar Ave. Sunnyvale, CA 94085

Re: K032852

Trade/Device Name: Autopulse Resuscitation System, Model 100 Regulation Number: 870.5200 Regulation Name: External Cardiac Compressor Regulatory Class: III Product Code: DRM Dated: October 31, 2003 Received: November 3, 2003

Dear Mr. Katz:

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. Bob H. Katz

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 (301) 594-4646. 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,

Chiu Lin, Ph.D.

Director Division of Anesthesiology, General Hospital, Infection Control and Dental 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 K032852

Device Name:

AutoPulse™ Resuscitation System Model 100

Indications for Use:

f. W. Aterlin

Infection

510(k) Number: K032852

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use V (Per 21 CFR 801.109)

Over-The-Counter Use ________ (Optional Format 1-2-96)

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.