(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.
§ 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).