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1. The device is designed to provide signals from which systolic and diastolic pressures can be derived through the use of the Oscillometric method. The device also measure pulse rate.
2. The device is for adult use only.
3. The device is for use at home or while traveling.

Not Found

The provided document is a 510(k) clearance letter from the FDA for the MS-930 Mars Inflate-Read Blood Pressure Monitor. It confirms that the device is substantially equivalent to legally marketed predicate devices. However, the document does not contain the detailed acceptance criteria or the study data that proves the device meets those criteria, nor other requested information such as MRMC study details or training set information.

The letter primarily focuses on the regulatory clearance and general requirements for marketing the device. It states the basic indications for use (measuring systolic, diastolic pressures, and pulse rate using the oscillometric method, for adult, home, or travel use) but doesn't provide specific performance metrics.

Therefore, I cannot fulfill your request for:

• A "table of acceptance criteria and the reported device performance."
• "Sample size used for the test set and the data provenance."
• "Number of experts used to establish the ground truth."
• "Adjudication method."
• "If a multi reader multi case (MRMC) comparative effectiveness study was done."
• "If a standalone (i.e. algorithm only without human-in-the-loop performance) was done."
• "The type of ground truth used."
• "The sample size for the training set."
• "How the ground truth for the training set was established."

This type of detailed study information is typically found in the 510(k) submission itself (which is often much more extensive than the clearance letter) or in associated clinical study reports, none of which are present in the provided text.

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