Results from Bland-Altman analysis for EarlySense investigational device versus Masimo Rad-97 reference device heart rate (HR) and respiratory rate (RR) measurements
| Open label | Closed-label round 1 | Closed-label round 2 | Closed-label round 3 | |
| EarlySense HR compared with Masimo Rad-97 HR | ||||
| Mean Masimo Rad-97 HR | 132.3 | 128.2 | 139.1 | 130.2 |
| Normalised bias (95% CI) | −0.5% (−1.2% to 0.2%) | −1.2% (−1.8% to −0.7%) | −0.4% (−1.1% to 0.3%) | −0.6% (−0.9% to −0.4%) |
| Normalised spread between 95% LOA (upper and lower 95% LOA) | 19.7% (−10.4% to 9.4%) | 15.3% (−8.9% to 6.4%) | 20.1% (−10.5% to 9.7%) | 6.2% (−3.7% to 2.5%) |
| Normalised RMSD | 5.0% | 4.1% | 5.1% | 1.7% |
| EarlySense RR compared with Masimo Rad-97 RR manual count | ||||
| Mean Masimo Rad-97 RR | 48.0 | 51.7 | 54.2 | 48.5 |
| Normalised bias (95% CI) | 3.0% (1.4% to 4.6%) | 0.3% (−1.0% to 1.7%) | 2.5% (1.6% to 3.4%) | 3.3% (2.4% to 4.3%) |
| Normalised spread between 95% LOA (upper and lower 95% LOA) | 45.3% (−19.7% to 25.6%) | 37.6% (−18.4% to 19.1%) | 24.8% (−9.9% to 14.9%) | 27.3% (−10.4% to 17.0%) |
| Normalised RMSD | 11.9% | 9.6% | 6.8% | 7.7% |
| EarlySense RR compared with Masimo Rad-97 RR median | ||||
| Mean Masimo Rad-97 RR | 50.3 | 53.5 | 56.4 | 50.7 |
| Normalised bias (95% CI) | −1.9% (−3.4% to −0.4%) | −3.1% (−4.4% to −1.8%) | −1.5% (−2.2% to −0.8%) | −1.2% (−1.9% to − 0.5%) |
| Normalised spread between 95% LOA (upper and lower 95% LOA) | 41.6% (−22.7% to 18.9%) | 35.9% (−21.1% to 14.9%) | 19.2% (−11.1% to 8.2%) | 19.8% (−11.1% to 8.7%) |
| Normalised RMSD | 10.8% | 9.7% | 5.1% | 5.2% |
LOA, limits of agreement; RMSD, root-mean-square deviation.