Common use of Effectiveness Analyses Clause in Contracts

Effectiveness Analyses. For the primary endpoint , separate summaries will be prepared, when applicable, for the Completed and the Discontinued analysis sets as follows: • Completed Control (eyes/subjects) • Completed Test (eyes/subjects) • Discontinued Control (eyes/subjects) • Discontinued Test (eyes/subjects) No inferential testing will be performed on effectiveness endpoints, and format of the reporting tables will reference FDA’s 510(k) guidance document (Clinical Appendix C, Summary of Reporting Tables) as well as the ISO guidance as specified in section A.3 (Reporting of results) of ISO 11980:2012.

Effectiveness Analyses. For each of the primary endpoint and supportive effectiveness endpoints, separate summaries summary tables will be prepared, when applicable, for the Completed and the Discontinued analysis sets as follows: •  Completed Control (eyes/subjects) •  Completed Test (eyes/subjects) •  Discontinued Control (eyes/subjects) •  Discontinued Test (eyes/subjects) No inferential testing will be performed on effectiveness endpoints, and format of the reporting tables will reference follow FDA’s 510(k) guidance document (Clinical Appendix C, Summary of Reporting Tables) as well as the ISO guidance as specified in section Section A.3 (Reporting of results) of ISO 11980:2012.