The Q-Stress Echo™ Bed is intended for use in stress echocardiography examination. The Q-Stress Echo™ Bed provides an exercise source that delivers programmable, controlled variable resistance.

The Q-Stress Echo™ Bed incorporates an electrocardiograph that records either normal conditions or patterns of arrhythmia and/or rate abnormalities in patients. In addition, the stress echo workstation provides "QRS" complex to a cardiac ultrasound device to be used to capture images (heart beats), either digitally or on videotape, such that each image begins at the time systole begins.

Device Description

The Q-Stress Echo™ Bed is a complete integrated stress echocardiography system. The Q-Stress Echo™ Bed combines the Stress Echo™ Bed / Table with an electrocardiograph. The Stress Echo™ Bed provides an exercise source that delivers programmable, controlled variable resistance, while the ECG provides the patient monitoring and recording. Several models of the Stress Echo Bed/Table are available with features that include height adjustability, Trendelenburg, dual, lateral tilt, and computer controllers.

AI/ML Overview

Here's an analysis of the provided text regarding the Q-Stress Echo™ Bed, focusing on acceptance criteria and the study performed:

This document describes a device (Q-Stress Echo™ Bed) that is primarily a physical exercise and monitoring system. It's not an AI/ML powered device, therefore many of the typical acceptance criteria and study details for such systems (like sensitivity, specificity, F1-score, MRMC studies, training set details) are not applicable. The details provided are for a predicate device comparison and performance bench testing for a physical medical device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria (Inferred)	Reported Device Performance
Functional Equivalence	Device must provide an integrated exercise source and electrocardiograph for cardiovascular monitoring, similar to the predicate device.	"The Q-Stress Echo™ Bed and the predicate device incorporate the same Stress Echo™ Bed and an electrocardiograph." "The fundamental technical characteristics... are equivalent." "The Q-Stress Echo™ Bed and the Vertex System function by providing the user with an integrated exercise source and electrocardiograph..."
Exercise Source	• Deliver programmable, controlled variable resistance. • Utilize a supine bicycle for exercise. • Run preprogrammed exercise protocols.	"Provides an exercise source that delivers programmable, controlled variable resistance." "The Q-Stress Echo™ Bed utilizes a supine bicycle for the exercise source." "Preprogrammed exercise protocols are run for purposes of electrocardiographic monitoring."
Electrocardiograph (ECG)	• Record normal conditions, arrhythmia, and/or rate abnormalities. • Provide "QRS" complex to a cardiac ultrasound device for image capture. • Print ECG reports, trends, averages, and ST segments.	"Incorporates an electrocardiograph that records either normal conditions or patterns of arrhythmia and/or rate abnormalities." "Provides 'QRS' complex to a cardiac ultrasound device to be used to capture images..." "ECG reports, trends, averages and ST segments are printed by the Q-Stress Echo™ Bed."
Safety and Performance	Device must perform as intended and safely	"The Q-Stress Echo™ Bed was subjected to performance bench testing. Physical performance studies and software evaluation were conducted to verify that the Q-Stress Echo™ Bed performed as intended." "The Q-Stress Echo™ Bed was found to perform as intended during verification and validation testing."
Substantial Equivalence	Device must be substantially equivalent to the Vertex System.	"The Q-Stress Echo™ Bed is substantially equivalent to the Vertex System in commercial distribution by Medical Positioning."

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

The document describes performance bench testing, physical performance studies, and software evaluation. These are laboratory/engineering tests, not clinical studies involving human patient data in the typical sense of a "test set" for an AI/ML algorithm. Therefore, there is no mention of a sample size for a test set in the context of patient data, nor its provenance (country of origin, retrospective/prospective).

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

This information is not applicable as the described tests are technical performance evaluations of a physical and software system, not diagnostic assessments based on expert-established ground truth.

4. Adjudication Method for the Test Set

This is not applicable as there is no "test set" in the context of patient data requiring expert adjudication.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is specifically designed for evaluating the diagnostic performance of AI or human readers, typically in image interpretation, and is not relevant to the performance testing of a physical stress echo bed system.

6. Standalone (Algorithm Only) Performance Study

No, a standalone performance study (algorithm only) was not done. The Q-Stress Echo™ Bed is a physical medical device system with integrated software, not a standalone algorithm.

7. Type of Ground Truth Used

The "ground truth" for this device's performance was based on the device's technical specifications and intended functionality. It was likely established through:

Engineering specifications and design requirements: Did the exercise source deliver the programmed resistance accurately? Did the ECG accurately record the electrical signals and "QRS" complex?
Comparisons to known good outputs: Did the ECG reports, trends, and ST segments match expected outcomes for various simulated conditions?
Predicate device characteristics: The primary "ground truth" for substantial equivalence was the established performance and characteristics of the predicate Vertex System.

8. Sample Size for the Training Set

This information is not applicable. The Q-Stress Echo™ Bed is described as a physical system with integrated ECG functionality following established specifications, not an AI/ML device that requires a "training set" for model development.

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

This information is not applicable for the reasons stated above.

Summary

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O-Stress Echo™ Bed Special Premarket 510(k) Notification

Koz 117 |

MAY 0 8 2002

DEVICE DESCRIPTION 16.4

SUBSTANTIAL EQUIVALENCE 16.5

The Q-Stress Echo™ Bed is substantially equivalent to the Vertex System in commercial distribution by Medical Positioning. The Q-Stress Echo™ Bed and the predicate device incorporate the same Stress Echo™ Bed and an electrocardiograph. The Q-Stress Echo™ Bed incorporates the Q-Stress electrocardiograph manufactured by Quinton Instruments.

The fundamental technical characteristics of the Q-Stress Echo™ Bed and the Vertex System are equivalent and are listed on the comparison charts provided in this 510(k) submission. The Q-Stress Echo™ Bed and the Vertex System function by providing the user with an integrated exercise source and electrocardiograph for use during cardiovascular monitoring.

INTENDED USE 16.6

The O-Stress Echo™ Bed is intended for use in stress echocardiography examination. The Q-Stress Echo™ Bed provides an exercise source that delivers programmable, controlled variable resistance.

The Q-Stress Echo™ Bed incorporates an electrocardiograph that records either normal conditions or patterns of arrhythmia and/or rate abnormalities in patients.

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In addition, the Q-Stress Echo™ Bed provides "QRS" complex to a cardiac ultrasound device to be used to capture images (heart beats), either digitally or on videotape, such that each image begins at the time systole begins.

TECHNOLOGICAL CHARACTERISTICS 16.7

The technological characteristics of the Q-Stress Echo™ Bed are equivalent to those of the Vertex System. The Q-Stress Echo™ Bed utilizes a supine bicycle for the exercise source. Preprogrammed exercise protocols are run for purposes of electrocardiographic monitoring. The ECG used in the Q-Stress Echo™ Bed is the Quinton Q-Stress electrocardiograph that has been cleared for commercial distribution under K001492. ECG reports, trends, averages and ST segments are printed by the Q-Stress Echo™ Bed. The Q-Stress Echo™ Bed is connected using standard patient electrodes and leads that are not included in the system.

16.8 PERFORMANCE DATA

The Q-Stress Echo™ Bed was subjected to performance bench testing. Physical performance studies and software evaluation were conducted to verify that the Q-Stress Echo™ Bed performed as intended.

CONCLUSIONS 16.9

This notification contains all information required by 21 CFR 807.87. The Q-Stress Echo™ Bed was found to perform as intended during verification and validation testing. The Q-Stress Echo™ Bed is substantially equivalent to the current Vertex System in commercial distribution. The Q-Stress Echo™ Bed is intended for use in stress echocardiography examination. The Q-Stress Echo™ Bed provides an exercise source that delivers programmable, controlled variable resistance.

p.212

15021171

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 0 8 2002

Medical Positioning, Inc. c/o Ms. Carol Patterson President Patterson Consulting Group, Inc. 21911 Erie Lane Lake Forest, CA 92630

Re: K021171

Trade Name: Q-Stress Echo™ Bed Regulation Name: Electrocardiograph Regulation Number: 21 CFR 870.2340 Regulatory Class: Class II (two) Product Code: 74 DPS Dated: April 11, 2002 Received: April 12, 2002

Dear Ms. Patterson:

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. Carol Patterson

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) 594-4646. 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,

Neda Tuh

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

Enclosure

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Q-Stress Echo™ Bed Special Premarket 510(k) Notification

INDICATIONS FOR USE

510(k) Number:

KOZ 117 1

Device Name:

Q-Stress EchoTM Bed

Indications for Use:

The Q-Stress Echo™ Bed is intended for use in stress echocardiography examination. The Q-Stress Echo™ Bed provides an exercise source that delivers programmable, controlled variable resistance.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Oelk Tell
Division of Cardiovascular & Respiratory Devices
510(k) Number K021171

Prescription Use $\checkmark$

Over-The-

Over-The-Counter Use

(Per 21 CFR 801.109)

CONFIDENTIAL

Regulation Number and Section

§ 870.2340 Electrocardiograph.

(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).