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

The M-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 Mortara Stress Echo™ Bed is a complete integrated stress echocardiography system. The Mortara 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

The provided text describes a 510(k) submission for the Mortara Stress Echo™ Bed. This submission focuses on establishing substantial equivalence to previously cleared devices rather than providing a detailed study of the device's diagnostic performance against specific acceptance criteria. Therefore, several aspects of your request, particularly those related to AI algorithm performance and ground truth establishment, are not applicable.

Here's the information that can be extracted or deduced from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not specify quantitative acceptance criteria in terms of diagnostic performance metrics (e.g., sensitivity, specificity, AUC). Instead, it relies on demonstrating substantial equivalence to predicate devices and verifying intended performance through bench testing.

Acceptance Criteria	Reported Device Performance
Performs as intended	"The Mortara Stress Echo™ Bed was found to perform as intended during verification and validation testing."
Substantially equivalent to predicate devices (Vertex System and Q-Stress Echo Bed for stress echo functionality; Mortara X-Scribe II for electrocardiograph)	"The Mortara Stress Echo™ Bed is substantially equivalent to the Vertex System and the Q-Stress Echo™ currently in commercial distribution by Medical Positioning... The fundamental technical characteristics... are equivalent..."
Provides an exercise source that delivers programmable, controlled variable resistance.	"The Mortara Stress Echo™ Bed provides an exercise source that delivers programmable, controlled variable resistance."
Incorporates an electrocardiograph that records either normal conditions or patterns of arrhythmia and/or rate abnormalities in patients.	"The Mortara Stress Echo™ Bed incorporates an electrocardiograph that records either normal conditions or patterns of arrhythmia and/or rate abnormalities in patients."
Provides "QRS" complex to a cardiac ultrasound device for image capture.	"The Mortara Stress Echo™ Bed provides 'QRS' complex to a cardiac ultrasound device to be used to capture images (heart beats)..."

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

Sample Size: Not specified. The document only mentions "performance bench testing" and "Physical performance studies and software evaluation." These typically involve testing the device's mechanical, electrical, and software functionalities, not necessarily a patient-based test set with diagnostic outcomes.
Data Provenance: Not specified. The nature of "bench testing" suggests controlled lab conditions rather than patient data from a specific country, and it does not indicate whether it was retrospective or prospective.

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

This information is not applicable. The device is a medical apparatus (a stress echo bed with an integrated ECG), not an AI diagnostic algorithm. Therefore, "ground truth" as typically defined for AI performance studies (e.g., disease diagnosis by experts) is not relevant in this context. The "ground truth" for this device would be its ability to perform its physical and electrical functions as intended.

4. Adjudication method for the test set:

Not applicable. As described above, this is not an AI diagnostic study where adjudication of human expert opinions would be necessary.

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 is not an AI-assisted diagnostic device, and therefore no MRMC study comparing human readers with and without AI assistance was conducted.

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

Not applicable. This is not an algorithm. It's a physical medical device.

7. The type of ground truth used:

The "ground truth" for this device would be its adherence to established engineering specifications, safety standards, and functional requirements. For example, the accuracy of its ECG readings would be verified against known electrical signals, and the programmability and controlled resistance of the exercise mechanism would be verified against calibrated measurements. It would not typically involve expert consensus, pathology, or outcomes data in the sense used for diagnostic AI.

8. The sample size for the training set:

Not applicable. This is a medical device, not an AI model that requires a training set.

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

Not applicable, as there is no training set for this type of device.

Summary

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KO82967

SECTION 16: SUMMARY OF SAFETY AND EFFECTIVENESS

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92.

MAR 2 6 2009

16.1 SUBMITTER INFORMATION

a. Company Name:	Medical Positioning, Inc.
b. Company Address:	1717 WashingtonKansas City, MO 64108
c. Company Phone:Company Facsimile:	(816) 474-1555(816) 474-7755
d. Contact Person:	Michael G. Falbo, Sr.Vice President, Product Development
e. Date Summary Prepared:	September 30, 2008

DEVICE IDENTIFICATION 16.2.

a. Trade/Proprietary Name:	Mortara Stress Echo™ Bed
b. Classification Name:	Electrocardiograph21 CFR 870.2340

16.3 IDENTIFICATION OF PREDICATE DEVICE

Company	Device	510(k) No.	Date Cleared
Medical Positioning	Vertex System	K002822	01/30/01
Medical Positioning	Q-Stress Echo Bed	-	05/08/02
Mortara Instruments	Mortara X-Scribe II	K022618	09/06/02

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16.4 DEVICE DESCRIPTION

SUBSTANTIAL EQUIVALENCE 16.5

The Mortara Stress Echo™ Bed is substantially equivalent to the Vertex System and the Q-Stress Echo™ currently in commercial distribution by Medical Positioning. The Mortara Stress Echo™ Bed and the predicate devices incorporate the same Stress Echo™ Bed and an electrocardiograph. The Mortara Stress Echo™ Bed incorporates the Mortara X-Scribe II electrocardiograph manufactured by Mortara Instruments.

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

INTENDED USE 16.6

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

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

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patients. In addition, the Mortara Stress Echo™ Bed provides "ORS" 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 Mortara Stress Echo™ Bed are equivalent to those of the Vertex System and the Q-Stress Echo™ Bed. The Mortara 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 Mortara Stress Echo™ Bed is the Mortara X-Scribe II electrocardiograph that has been cleared for commercial distribution under K022618. ECG reports, trends, averages and ST segments are printed by the Mortara Stress Echo™ Bed. The Mortara Stress Echo™ Bed is connected using standard patient electrodes and leads that are not included in the system.

16.8 PERFORMANCE DATA

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

CONCLUSIONS 16.9

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

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle faces left. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 6 2009

Medical Positioning, Inc. c/o Ms. Carol White Consultant 21521 Hummingbird St. Trabuco Canyon, CA 92679

Re: K082967

Trade Name: M-Stress Echo Bed Regulation Number: 21 CFR 870. 2340 Regulation Name: Electrocariograph Regulatory Class: Class II (two) Product Code: DPS Dated: February 23, 2009 Received: March 2, 2009

Dear Ms. White:

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 White

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

Sincerely yours

Bram D. Zukerman, M.D.

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):

Device Name:

K082967

M-Stress Echo Bed TM

Indications For Use:

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

Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Offm
Division of Cardiovascular Devices
510(k) Number K082967-

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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).