Table 5.

Conditions of Study Success.

Parameter	Threshold for success	Study results	Meets threshold
Mean paired κ statistic	>0.61	0.7754	Yes
Mean paired κ statistic for determining eligibility	>0.80	0.9301	Yes
Mean paired κ statistic for determining hemostasis	>0.80	0.9301	Yes
No more than 1 UADE or SADE as determined by the IDMC	<1 UADE or SADE	1 possible SADE	Yes

Abbreviations: IDMC, Independent Data Monitoring Committee; SADE, serious adverse device effect; UADE, unanticipated adverse device effect.