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510(k) Data Aggregation
(25 days)
The device is intended to acquire, process, record, archive, analyze, and output electrocardiographic data during physiologic stress testing. The device may interface with external devices, including a treadmill or ergometer for dynamic exercise evaluation, non-invasive blood pressure equipment, and computer communications equipment. The device is intended for use in a clinical setting by trained personnel under the supervision of a licensed physician. The device is intended for adult populations, typically symptomatic. The device is not intended to be used as a vital signs physiological monitor.
Q-Stress and HeartStride are diagnostic devices capable of ECG monitoring; ST analysis and ventricular ectopic beat detection; generation, review, and storage of stress reports; and treadmill or ergometer control. These devices consist of a patient cable, preamplifier, PC, display, mouse, printer, keyboard, and isolation power supply. Approved serial devices such as non-invasive blood pressure measurement may be supported by these devices. Electrocardiographic data is obtained by the preamplifier and sent to the CPU for processing. The user may generate reports for display or may opt to print results via a printer.
The provided text is a 510(k) summary for the Cardiac Science Corporation's Q-Stress and HeartStride devices. It describes the devices, their intended use, and their substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, expert ground truth, or MRMC studies.
The document is a regulatory submission focused on demonstrating substantial equivalence to a previously cleared device (K001492, Q-Stress). In such submissions, extensive clinical studies with detailed performance metrics are often not required if the new device shares the same intended use, technological characteristics, and fundamental principles of operation as a legally marketed predicate device. The FDA typically relies on the established safety and effectiveness of the predicate.
Therefore, I cannot provide the requested information based on the input text. The table and other details you asked for are not present in this 510(k) summary.
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(26 days)
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.
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.
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.
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