(252 days)
The Scian Automatic Digital Blood Pressure Monitor, Models LD-562U, LD-588U & LD-533U, are devices intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. In addition, they can detect the appearance of irregular heartbeat during measurement, and give a warning signal once the irregular heartbeat is detected.
Not Found
The provided text is a 510(k) summary for a blood pressure monitor. It includes information about the device's intended use and FDA clearance, but it does not contain the detailed study information needed to answer your request about acceptance criteria and study proving device performance.
Specifically, the document lacks:
- A table of acceptance criteria and reported device performance.
- Information about the sample size, data provenance, number of experts, adjudication method, or ground truth used for performance studies.
- Any mention of a multi-reader multi-case (MRMC) comparative effectiveness study or standalone algorithm performance.
- Details regarding the training set size or how its ground truth was established.
This document primarily serves as an FDA clearance letter and an "Indications for Use" statement, not a scientific study report. To get the information you asked for, you would need to consult a different document, such as the actual clinical or performance study report submitted to the FDA, which is not provided here.
§ 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).