You mentioned effectiveness in some slides, but then focused on Performance and also mentioned patient benefit for CER; could you please clarify what the key requirements are?

They belong to the same category. The benefit of your device generally refers to the effectiveness data or clinical performance data. And on the other hand, the risk of your device generally is related to the safety side.

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You Mentioned Effectiveness In Some Slides, But Then Focused On Performance And Also Mentioned Patient Benefit For CER; Could You Please Clarify What The Key Requirements Are?

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