(29 days)
This device is intended for use by medically trained personnel in a clinical setting to continually monitor and display diastolic, systolic, and mean blood pressures and pulse rate. The device is intended for use on adult patients with a palpable pulse.
Not Found
I am sorry, but based on the provided document, I cannot fulfill your request. The document is a 510(k) clearance letter from the FDA for a non-invasive blood pressure monitoring system. It confirms that the device is substantially equivalent to a legally marketed predicate device and outlines regulatory conditions.
However, the document does not contain any information regarding:
- Acceptance criteria or reported device performance.
- Sample sizes or data provenance for any studies.
- Number or qualifications of experts used to establish ground truth.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance studies.
- Type of ground truth used.
- Sample size for training sets.
- How ground truth for training sets was established.
The document focuses solely on the regulatory clearance process and the device's indications for use, without delving into the detailed technical or clinical study results that would contain the information you are asking for.
§ 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).