(181 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.
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I cannot fulfill this request. The provided text is an FDA 510(k) clearance letter for an Arm Blood Pressure Monitor. It confirms the device's substantial equivalence to previously marketed devices and outlines regulatory requirements. However, this document does not contain any information about acceptance criteria, device performance details, or a study proving that the device meets acceptance criteria.
Specifically, it lacks:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test or training sets, data provenance, or details about ground truth establishment.
- Information on expert involvement, adjudication methods, or MRMC studies.
- Any data related to standalone algorithm performance.
Therefore, I cannot extract the requested information from the provided input.
§ 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).