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The Datex-Ohmeda NE12STPR module (model family M-NE12STPR) and accessories are indicated for monitoring of hemodynamic parameters of all hospital patients. The hemodynamic parameters of the module comprise ECG including ST-segment and arrhythmia, Impedance respiration, Including temperature, SpO2 and invasive blood pressure.

Impedance Respiration measurement is indicated for patient's ages 3 and up.

The NIBP measurement is indicated for patients with weight from 5kg (11lb.) up.

The device is indicated for use by qualified medical personnel only.

NE12STPR Module (Model family M-NE12STPR) and accessories

I apologize, but the provided text from the FDA 510(k) letter for the DATEX-OHMEDA NE12STPR Module does not contain the detailed information necessary to describe the acceptance criteria and the study that proves the device meets those criteria in the format you requested.

This document is a clearance letter, stating that the device is substantially equivalent to a legally marketed predicate. It does not typically include the specifics of the performance studies themselves, such as:

• A table of acceptance criteria and reported performance
• Sample sizes, data provenance, or ground truth establishment details
• Number and qualifications of experts
• Adjudication methods
• Details of MRMC or standalone studies
• Specific ground truth types for test or training sets

These details would typically be found in the actual 510(k) submission document itself, which is a much more extensive technical file submitted to the FDA, or in associated test reports. The clearance letter only refers to the submission and grants market clearance.

Therefore, I cannot fulfill your request with the provided input.

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