(142 days)
Measure blood pressure (systolic and diastolic) and pulse rate.
Not Found
The provided document is a 510(k) clearance letter from the FDA for a blood pressure monitor, not a study report. Therefore, it does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets them.
The letter confirms that the device, Arm-Type Fully Automatic Digital Blood Pressure Monitor, Model BP-35, is substantially equivalent to legally marketed predicate devices. This determination is based on a review of the manufacturer's 510(k) submission, which would have included performance data, but that data is not present in this regulatory correspondence.
To answer your request, I would need access to the actual 510(k) submission or a separate study report for the Sejoy BP-35 device. The current document only provides:
- Device Name: Arm-Type Fully Automatic Digital Blood Pressure Monitor, Model BP-35
- Intended Use: Measure blood pressure (systolic and diastolic) and pulse rate.
- Regulatory Class: Class II
- Product Code: DXN
Without the actual performance data and study details, I cannot fill out the requested table or address the specific points about sample size, ground truth, expert qualifications, adjudication methods, or MRMC studies.
§ 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).