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The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population with arm circumference ranging from 9 inches to 17 inches (from 22 cm to 42 cm).

The device is a digital monitor intended for use in measuring blood pressure and pulse rate.

This appears to be an FDA clearance letter for a medical device, specifically an Omron Automatic Blood Pressure Monitor (Model HEM-773AC). The provided text describes the regulatory clearance process and includes an "Indication for Use" statement.

However, the document does not contain any information regarding acceptance criteria for device performance or a study proving that the device meets those criteria.

This type of FDA letter confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed. It does not typically include the detailed study results or performance metrics that would be part of a submission to demonstrate safety and effectiveness. Those details would be in the original 510(k) submission document itself, which is not provided here.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method
5. MRMC comparative effectiveness study details
6. Standalone performance details
7. Type of ground truth used
8. Sample size for the training set
9. How the ground truth for the training set was established

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