ILT-U-1733
ECG Ventricular beat detection software verification (Black box testing)
Sensitivity (Se) = TP / (TP + FN) Positive Predictivity (P+) = TP / (TP + FP) TP: number of true detection FN: number of undetected beats FP: num, according to IEC 62304 – clause 5.7.1.
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ILT-U-2045
Testing of Requirements for quality of Ready to Use Software Product (RUSP) / COTS Software
