(125 days)
The Arm Blood Pressure Monitor is intended to measure the systolic blood pressure as well as the pulse rate of person via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the upper arm. It can be used at medical facilities or at home. The intended upper arm circumference is 22-42cm. Suitable for adults and adolescents who over the age of 12.
Not Found
This FDA 510(k) clearance letter for the Alicn Medical Shenzhen,Inc Arm Blood Pressure Monitor does not contain the detailed information required to answer your request about acceptance criteria and the study that proves the device meets those criteria.
The document primarily states that the FDA has reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices. It also outlines the regulatory obligations of the manufacturer and specifies the "Indications for Use" for the blood pressure monitor.
Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, ground truth establishment, or multi-reader multi-case studies based solely on the provided text.
This type of detailed study information is typically found in the 510(k) submission itself (which is not publicly available in its entirety, though a summary is), or in associated clinical trial reports, rather than in the FDA's clearance letter.
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).