(46 days)
The YA HORNG PC Compatible Blood Pressure Monitor AK-4000TU, BP-410U, BP-410R; and Automatic Digital Wrist Blood Pressure Monitor BP-420U, BP-420R are noninvasive blood pressure measurement systems intended to measure the systolic and diastolic blood pressures and pulse rate of an adult individual, over age 18, at home by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to be 5.3" - 8.5".
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The provided text is a 510(k) summary for a blood pressure monitor. It includes information about the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain any details about acceptance criteria, a study proving device performance against those criteria, or any of the specific information requested in your prompt (e.g., sample size, ground truth, expert qualifications, MRMC studies, standalone performance).
The 510(k) summary focuses on establishing substantial equivalence to a legally marketed predicate device (AMLUCK AUTOMATIC DIGITAL WRIST BLOOD PRESSURE MONITOR AK-3000 / AK-4000) based on similar indications for use and technology. It does not present a de novo clinical study with specific acceptance criteria and performance data as you've requested.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details based on the provided text. The document is primarily a regulatory submission rather than a detailed performance study report.
§ 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).