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The Testa"Be® monitor is an automatic oscillometric measuring system designed to take non-invasive blood pressure measurements. It measures systolic pressure, diastolic pressure, mean arterial pressure and heart rate.

The Testa "BP® monitor is intended to be used on neonate, pediatric and adult populations during MR-examinations at a maximum magnetic field strength of 20mT.

The Testa"(820) Blood Pressure Monitor is an automatic non-invasive blood pressure (NIBP) measurement system that is intended for use in an MR-environment at a maximum magnetic field strength of 20mT. The completed system meets the requirements of AAMI standard SP10:2003+A1:2003. The Testal Pro design makes it possible to position the system within an RF-shielded MRI-room.

The Testa VBP® measures and displays:

1. Systolic Pressure
2. Diastolic Pressure
3. Heart Rate (BPM)
4. Mean Arterial Pressure (MAP)

MIPM will distribute pressure cuffs for use with the Testa" that are manufactured by other medical device manufacturing companies, and which are already cleared by FDA for sale in the USA.

The provided text describes a 510(k) summary for the "Tesla NIBP" device but unfortunately does not contain the detailed study information required to answer your specific questions about acceptance criteria and study design.

The 510(k) summary focuses on general device description, intended use, classification, and substantial equivalence to predicate devices, as well as regulatory compliance. It mentions that "The completed system meets the requirements of AAMI standard SP10:2003+A1:2003," which is a key standard for non-invasive sphygmomanometers. However, it does not provide the specific performance criteria from that standard or the results of a study demonstrating the device meets those criteria.

Therefore, I cannot provide a complete answer to your request based on the given input.

I can only confirm the following based on the provided text:

• Acceptance Criteria: The device is stated to meet the requirements of AAMI standard SP10:2003+A1:2003. However, the specific metrics (e.g., accuracy, precision) from this standard are not detailed in the provided document.
• Study Details: There is no description of a specific study performed to demonstrate the device meets acceptance criteria.
• Performance Data: No specific performance metrics (e.g., accuracy, sensitivity, specificity, or differences from ground truth) are reported for the device in the provided text.

To answer your questions thoroughly, I would need a more detailed study report or clinical data section that is typically part of a 510(k) submission but is not included in the provided summary pages.

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