(205 days)
The devices are intended to measure the systolic blood pressure, and pulse rate of an adult more than 12 years old individual by using a non-invasive technique, in which an inflatable cuff (220mm ~ 320mm) is wrapped around the arm. It can be used in medical facilities or at home. It is supplied for OTC use.
Digital Blood Pressure Monitor (Arm Type)
I am sorry, but based on the provided document, the acceptance criteria and study details you requested are not available. The document is an FDA 510(k) clearance letter for a "Digital Blood Pressure Monitor (Arm Type)," which confirms the device's substantial equivalence to a predicate device and outlines regulatory requirements. It does not contain information about specific performance acceptance criteria or details of a study proving the device meets them.
The sections of the document discuss:
- The FDA's 510(k) review and substantial equivalence determination.
- General controls and additional regulations applicable to the device.
- Instructions for contact and further regulatory information.
- Indications for Use for the device.
There is no mention of:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test or training sets.
- Data provenance.
- Number or qualifications of experts for ground truth establishment.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance studies.
- Type of ground truth used.
- How ground truth for a training set was established.
Blood pressure monitor clearances typically rely on adherence to recognized consensus standards for accuracy and performance (e.g., ISO 81060-2 for non-invasive sphygmomanometers) rather than complex ground truth establishment studies with expert consensus or pathology data, which are more common for diagnostic imaging or AI-based devices. However, the specific details of such compliance are not included in this general clearance letter.
Therefore, I cannot provide the requested information based on the text provided.
§ 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).