(90 days)
Ri-Mega is a sphygmomanometer and is intended to measure the blood pressure
Ri-Mega is a sphygmomanometer
This looks like a 510(k) clearance letter from the FDA for a blood pressure measuring device (sphygmomanometer) called "RI-Mega."
Unfortunately, the provided text does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria.
The document is a regulatory approval letter, specifically a 510(k) clearance, which states that the device is "substantially equivalent" to a legally marketed predicate device. This type of letter generally references the 510(k) submission, where the performance data and acceptance criteria would typically reside.
Therefore, I cannot provide the requested table and study details based solely on the provided text.
To answer your questions, I would need access to the actual 510(k) submission document for K972377, which would include the performance data, acceptance criteria, study design, and ground truth information.
However, I can deduce some general characteristics about this type of device and its typical evaluation:
Given it's a sphygmomanometer, the performance criteria would likely revolve around:
- Accuracy: How close the device's blood pressure readings are to a reference standard.
- Precision/Reproducibility: How consistent the device's readings are when measured multiple times under similar conditions.
- Bias: Systematic deviation from the reference.
- Safety: General safety characteristics, though for a manual sphygmomanometer, this is generally well-established.
The studies would typically involve:
- Comparing the device's readings against a recognized standard (e.g., auscultatory method by trained observers).
- Recruiting a diverse range of subjects.
Without the actual 510(k) submission, I must state that the requested information is not available in the provided text.
§ 870.1120 Blood pressure cuff.
(a)
Identification. A blood pressure cuff is a device that has an inflatable bladder in an inelastic sleeve (cuff) with a mechanism for inflating and deflating the bladder. The cuff is used in conjunction with another device to determine a subject's blood pressure.(b)
Classification. Class II (performance standards).