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The device is intended for use as a diagnostic device which retrieves, records, and produces a visual display the of electrical signal produced by the heart.

The device is a battery-operated, portable, 12 lead electrocardiograph which produces a 1, 3, 6, or 12 channel printout. Data can also be displayed on a the monitor, using computer personal application software package.

The provided text is a 510(k) summary for the Macquarie CT 200 Portable Electrocardiograph. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain information regarding acceptance criteria, device performance studies, or the methodologies for establishing ground truth.

Therefore, I cannot provide the requested information in the format specified because the necessary details are not present in the provided text.

Based on the content, the document is primarily focused on:

• Device Identification: K961798, Macquarie CT 200 Portable Electrocardiograph.
• Classification: Class II (74 DSP).
• Intended Use: As a diagnostic device to receive, record, and produce a visual display of the electrical signal produced by the heart.
• Technological Similarity: To other standard electrocardiographs producing multipage printouts and utilizing application software.
• Regulatory Communication: FDA's letter granting market clearance based on substantial equivalence to predicate devices.

The text does not include sections typically found in a clinical study report or a performance validation document, such as:

• Specific performance metrics (e.g., sensitivity, specificity, accuracy).
• Details of a test set, its size, or its provenance.
• Information about expert review, adjudication, or ground truth establishment.
• Any mention of standalone algorithm performance or human-in-the-loop studies.

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