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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.
• The device is for use at home or while traveling. 3.

MS-753 Mars Inflate-Read Blood Pressure Monitor

This document is a 510(k) clearance letter for the "MS-930 Mars Inflate-Read Blood Pressure Monitor". It does not contain the acceptance criteria and study details as requested. A 510(k) clearance letter typically states that a device is substantially equivalent to a predicate device, allowing it to be marketed, but it does not detail the specific performance studies and acceptance criteria from the submission itself.

Therefore, I cannot extract the requested information from the provided text. The document confirms the clearance of the device and its indications for use, but not the technical study details.

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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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• 1. The device is designed to provide signals from which systolic, diastolic pressures and H-Value (arterial stiffness index) can be derived through the use of the Oscillometric method. The device also measure pulse rate.
• 2. Adult Use Only
• 3. For use in the clinical setting or home use under the direction of a physician.

The device is designed to provide signals from which systolic, diastolic pressures and H-Value (arterial stiffness index) can be derived through the use of the Oscillometric method. The device also measure pulse rate.

The provided text is a 510(k) clearance letter from the FDA for the "Vital Vision Arterial Stiffness and Blood Pressure Monitor." It confirms that the device is substantially equivalent to a legally marketed predicate device. However, this document does not contain any information about the acceptance criteria, device performance, sample sizes, ground truth establishment, or study details.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and the study that proves the device meets them based on the provided text. The document focuses on regulatory clearance based on substantial equivalence, not on a detailed performance study report.

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The Mars MS-900S, MS-900SFM & MS-900SPM Auto Inflation Wrist Blood Pressure Monitors are designed to provide signals from which systolic and diastolic pressures can be derived through the use of the oscillometric method. The devices also measure pulse rate.

Mars MS-900S, MS-900SFM & MS-900SPM Auto Inflation Wrist Digital Blood Pressure Monitors

The provided text is a 510(k) clearance letter from the FDA for the Mars Medical Products MS-900S, MS-900SPM, and MS-900SFM Automatic Blood Pressure Monitors. It confirms the substantial equivalence of these devices to existing ones. However, this document does not contain the detailed study information required to answer your specific questions about acceptance criteria, device performance, sample sizes, ground truth establishment, or expert involvement in a clinical study.

The letter acknowledges the submission and clearance but does not provide the underlying data or results of the performance studies. Therefore, I cannot extract the information requested.

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