(351 days)
To be used before, during and after exercise. To be used while at rest. The primary function is as a Heart Tachometer. The user also can be alerted if various presets have been exceeded.
Not Found
This appears to be an FDA 510(k) clearance letter from 1997 for a device called "Heart Protector". This document primarily focuses on the regulatory clearance of a device based on substantial equivalence to a predicate device, rather than providing a detailed study report with specific acceptance criteria and performance metrics.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and comparative effectiveness studies cannot be extracted from the provided text.
The document only states the device's indications for use: "To be used before, during and after exercise. To be used while at rest. The primary function is as a Heart Tachometer. The user also can be alerted if various presets have been exceeded."
To answer your questions, a separate study report or regulatory submission would be required.
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).