Search Results

The Integriti Patient Monitor is intended for use on all adult and pediatric patients that require monitoring and collection of vital signs data, with alarm capability when vital signs exceed preset values. The information that is intended to be collected is from the ECG, SpO2, noninvasive and invasive blood pressures and temperature. The Integriti Patient Monitor is intended for use in all departments and locations of the hospital where such monitoring may take place, except in the proximity of magnetic resonance imaging. The Integriti Patient Monitor is also intended for use for patient vital signs monitoring during patient transport in the hospital environment. The Integriti Patient Monitor is intended for use by licensed practitioners. When there is no standard electrical power source, the Integriti Patient Monitor is intended for use using a 12 to 28 volt external power source. The Integriti Patient Monitor is also intended for use with patient information systems, acting as a source of vital signs information and as a terminal for accessing and entering information into the information system.

Not Found

I am sorry, but based on the provided text, I cannot provide the detailed information you are requesting about acceptance criteria and study data. The document provided is a 510(k) clearance letter from the FDA to Alliance Instruments for their "Integrity Patient II" (later referred to as "Integriti Patient Monitor").

This letter states that the device is "substantially equivalent" to legally marketed predicate devices. It discusses regulatory classifications, general controls, and permits the device to be marketed.

However, it does not contain:

1. A table of acceptance criteria or reported device performance.
2. Details about sample sizes, data provenance, number or qualifications of experts, or adjudication methods for a test set.
3. Information about multi-reader multi-case (MRMC) studies or standalone performance.
4. Specifics on the type or establishment of ground truth for training or test sets, or training set sample sizes.

The letter is a regulatory approval document, not a clinical study report or a detailed technical specification. To find the information you are looking for, you would typically need to consult a clinical trial report, a technical specifications document, or the 510(k) submission itself, none of which are provided here.

Ask a specific question about this device