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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.

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K Number

K021171

Device Name

Q-STRESS ECHO BED

Manufacturer

MEDICAL POSITIONING, INC.

Date Cleared

2002-05-08

(26 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K001492

Predicate For

N/A

Intended 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.

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.