(57 days)
RTT Digital Blood Pressure Monitor Model RTW-8010A is indicated for nonivasive measurement of systolic and diastolic blood pressure and determination of puslse rate from user's wrist .
Not Found
I am sorry, but the provided document does not contain the detailed information necessary to answer your request about the acceptance criteria, study details, and performance of the device. The document is an FDA 510(k) clearance letter for a "Real Tone Digital Blood Pressure Monitor, Model RTW-8010A," indicating that the device has been found substantially equivalent to legally marketed predicate devices.
While it mentions the device's indications for use (non-invasive measurement of systolic and diastolic blood pressure and pulse rate from the user's wrist), it does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for test sets or data provenance.
- Number of experts or their qualifications for establishing ground truth.
- Adjudication methods.
- Information about MRMC comparative effectiveness studies or human reader improvement.
- Standalone algorithm performance.
- Type of ground truth used (e.g., pathology, outcomes data).
- Sample size for training sets.
- How ground truth for the training set was established.
To obtain this information, you would typically need to refer to the full 510(k) submission document, which often includes more detailed testing protocols and results that are summarized in the clearance letter.
§ 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).