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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.

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