(53 days)
Rossmax Automatic Blood Pressure Monitor, Model MO701k is used to measure systolic, diastolic, and pulse rate for adult individual in a home environment.
Not Found
This is a 510(k) summary for a blood pressure monitor, which primarily focuses on regulatory clearance based on substantial equivalence to a predicate device. It does not contain the detailed performance study results that would typically be present for an AI/ML device or a novel medical device requiring extensive clinical trials to prove its performance against acceptance criteria.
Therefore, I cannot extract the specific information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth types. These types of details are not typically found in a 510(k) clearance document for a device like a blood pressure monitor, which usually relies on established standards and bench testing.
The document confirms the following:
- Device Name: Rossmax Automatic Blood Pressure Monitor, Model MO701k
- Intended Use: To measure systolic, diastolic, and pulse rate for adult individuals in a home environment.
- Regulatory Classification: Class II (two), Product Code DXN.
To answer your prompt thoroughly, I would need a different type of document, such as a detailed clinical study report or a dedicated performance evaluation report for the device.
§ 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).