The Stöckert S5 System, like the parent S3 System, is a modular system consisting of a console, various pumps, monitors, displays, controls, and user interfaces.

AI/ML Overview

This document describes the Stöckert S5 System, a heart-lung machine intended for use during cardiopulmonary bypass surgery. However, the provided text does not contain the detailed acceptance criteria or a study proving the device meets specific performance metrics in the format requested.

The document states: "Testing of the Stöckert S5 System demonstrated that the System fulfills prospectively defined performance criteria and included electrical safety, electromagnetic compatibility, software validation, and functional testing." This is a general statement of testing, but it does not provide the specific criteria or the results of those tests in a quantifiable manner.

Therefore, I cannot populate the table or answer most of the questions as the information is not present in the provided text.

Here's a breakdown of what can be inferred or what is explicitly missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (e.g., Specificity, Sensitivity, Accuracy, Precision, AUC, etc.)	Reported Device Performance
N/A (Not specified in the provided text)	N/A (Not specified in the provided text)

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 or prospective). The text only mentions "prospectively defined performance criteria" but doesn't detail the data used for the testing.

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

Not applicable. This device is a heart-lung machine, not an imaging or diagnostic device requiring expert interpretation for ground truth. The "ground truth" for such devices typically relates to engineering specifications and functional safety.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. See point 3.

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:

No. This is not an AI-assisted diagnostic or imaging device. It's a medical device for cardiopulmonary bypass.

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

Not applicable. This question is usually for diagnostic algorithms. For a mechanical device, performance is inherently "standalone" in its function, but the question's context implies AI. The device itself is a standalone system without an "algorithm only" performance that would be separated from human interaction in the way diagnostic AI is typically evaluated.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Implied Engineering and Safety Standards: For a heart-lung machine, the "ground truth" for performance testing would be adherence to established engineering specifications, electrical safety standards (e.g., IEC 60601-1), electromagnetic compatibility standards (e.g., IEC 60601-1-2), and verified software functionality according to design specifications. The document mentions "electrical safety, electromagnetic compatibility, software validation, and functional testing," which align with this type of ground truth.

8. The sample size for the training set:

Not applicable. This device is a physical medical device, not a machine learning model that requires a "training set."

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

Not applicable. See point 8.

In summary, the provided 510(k) summary focuses on establishing substantial equivalence to a predicate device (Stöckert S3 System) based on intended use, indications for use, operational characteristics, and fundamental technological characteristics. While it mentions performance testing, it does not elaborate on the specific acceptance criteria or detailed results of those tests in the way requested for a performance study.

Summary

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510(k) Summary Stöckert S5 System

K0600053

1. SPONSOR

Sorin Group Deutschland GmbH Lindberghstrasse 25 80939 Munich Germany Contact Person: Helmut Höfl Telephone: 011 49 89 323 010

Date Prepared: January 4, 2006

2. DEVICE NAME

Proprietary Name: Stöckert S5 System Common/Usual Name: Heart lung machine Classification Name: Multiple

3. PREDICATE DEVICES

Stöckert S3 System (multiple 510(k) numbers)

4. DEVICE DESCRIPTION

The Stöckert S5 System, like the parent S3 System, is a modular system consisting of a console, various pumps, monitors, displays, controls, and user interfaces.

ડ. INTENDED USE

The Stöckert S5 System is intended to be used during cardiopulmonary bypass surgery lasting six (6) hours or less.

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TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.

The Stöckert S5 System is an upgrade of the Stöckert S3 System. The Stöckert S5 System is substantially equivalent to the Stöckert S3 System based on intended use, indication for use, operational characteristics, and fundamental technological characteristics.

7. PERFORMANCE TESTING

Testing of the Stöckert S5 System demonstrated that the System fulfills prospectively defined performance criteria and included electrical safety, electromagnetic compatibility, software validation, and functional testing.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN = 2 2006

Medical Device Consultants, Inc. c/o Ms. Rosina Robinson Senior Staff Consultant 49 Plain Street North Attleboro, MA 02760

Re: K060053 Stöckert S5 System Regulation Number: 21 CFR 870.4220 Regulation Name: Heart Lung Machine Console Regulatory Class: Class II Product Code: DTQ Dated: May 22, 2006 Received: May 23, 2006

Dear Ms. Robinson:

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 - Ms. Rosina Robinson

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 (OS) 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Brimmer 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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510(k) Number (if known):

Stöckert S5 System Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications för Use:

The Stöckert S5 System is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less.

Prescription Use X (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Bhumima

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Regulation Number and Section

§ 870.4220 Cardiopulmonary bypass heart-lung machine console.

(a)
Identification. A cardiopulmonary bypass heart-lung machine console is a device that consists of a control panel and the electrical power and control circuitry for a heart-lung machine. The console is designed to interface with the basic units used in a gas exchange system, including the pumps, oxygenator, and heat exchanger.(b)
Classification. Class II (performance standards).