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510(k) Data Aggregation
(171 days)
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.
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.
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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