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The PMP BP Pro Blood Pressure Monitor is intended to be used for monitoring Blood Pressure (BP) and Heart Rate (HR) from the upper arm. BP and HR can be recorded and transferred to a remote hand held device/PC for viewing and processing.

The PMP4 BP Pro is used for self-testing by patients and by healthcare professionals at home and at medical settings to monitor blood pressure (systolic and diastolic) and pulse rate from the upper arm. The device consists of a table top monitor and a receiving program - the PMP4 Medical Application. The table top monitor obtains the blood pressure measurement through the oscillometric method, i.e. the blood movement through the artery in the upper arm are detected and converted into digital readings. For evaluation, the stored measurement results can be transmitted by Bluetooth interface to wirelyss mobile platform, e.g. PDA or a static platform, i.e., PC with the PMP4 Medical Application installed. The PMP4 Medical Application interfaces to the table-top monitor and is used to receive for Pro the test results and other medical data, to process and save these test results, and to synchroized and test results with the PMP4 Medical Center.

The PMP4 Medical Application is also designed to receive ECG, spirometric, glucometric, and oximetric parameters from other Card Guard medical testing accessories in addition to BP+HR.

When the table top monitor is not used to measure blood pressure, it displays time and date. The intended product users are Non-Medical Persons (NMP), i.e. persons expected to understand only basic medical data.

The provided text is related to the PMP4 BP Pro Blood Pressure Monitor's 510(k) summary, but it does not contain the acceptance criteria or a detailed study description to prove the device meets such criteria.

The document primarily focuses on:

• General information about the device and submitter.
• "Definition and Intended Use" of the device.
• "Referenced Standards" (e.g., medical device directives, quality management systems, biological evaluation). These standards define how the device should be designed and tested in general, but they don't provide specific acceptance criteria or study results for this particular device.
• "Method of Operation" (how the cuff inflates).
• "Substantial Equivalence" claim against predicate devices.
• Description of the "PMP4 Medical Application."
• The FDA's 510(k) clearance letter and Indications for Use statement.

Therefore, I cannot provide the requested information based on the input document. The summary does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample size, data provenance, or expert details for a test set.
3. Adjudication method.
4. MRMC comparative effectiveness study results.
5. Standalone algorithm performance.
6. Type of ground truth used.
7. Training set sample size or how its ground truth was established.

This document serves as a regulatory submission summary, not a detailed clinical or performance study report.

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BP Pro is intended to be used by adults at home to monitor Blood Pressure (systolic and diastolic) and pulse rate from the upper arm with arm circumference ranging from 9.4 inches to 16.5 inches (24 cm to 42 cm).

The BP Pro Blood Pressure Monitor is a fully automatic table model device that measures blood pressure by means of an inflatable cuff on the upper arm. It employs the Oscillometric Principle.

The provided text is a 510(k) summary for the BP Pro Blood Pressure Monitor. It does not contain information about acceptance criteria or a study proving device performance against such criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device based on identical technological characteristics.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set or data provenance.
• Number and qualifications of experts for ground truth.
• Adjudication method for the test set.
• MRMC comparative effectiveness study results.
• Standalone performance.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

The text explicitly states: "The BP Pro Blood Pressure Monitor is identical to the predicate I.E.M. device except for its name, hence it should raise no new questions of safety and effectiveness. This submitter concludes that the BP Pro Blood Pressure Monitor is therefore substantially equivalent to the predicate device." This indicates that the approval is based on equivalence, not a new performance study.

Ask a specific question about this device