(156 days)
The Wrist Automatic Blood Pressure Monitor LD-733 is device 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 wrist.
Wrist Automatic Blood Pressure Monitor Model: LD-733
I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is a 510(k) clearance letter from the FDA for a blood pressure monitor, which primarily confirms that the device is substantially equivalent to legally marketed predicate devices. It does not detail specific acceptance criteria, study methodologies, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/algorithm-based device as requested in the prompt.
Therefore, I cannot populate the table or answer the specific questions about a study design proving the device meets acceptance criteria.
§ 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).