Response

c. R-TF-025-007 (Summative Evaluation Report) has been updated with a new section, "Usability of Instructions for Use," which presents the results and conclusions regarding IFU usability for both intended user groups.

The summative evaluation assessed IFU usability through multiple test items defined in the protocol (R-TF-025-004). For ITP participants: task ITP-T-01 ("Access and read the IFU") directly assessed IFU accessibility and readability, achieving 100% success (18/18). The ITP Knowledge Assessment (Q1–Q6), which tests comprehension of IFU content, achieved 100% success across all questions and participants. For HCP participants: per the protocol (R-TF-025-004, §6), documentation review of the Clinical User Manual is a defined session phase identified as a critical task to be evaluated during the summative evaluation. All 18 HCP participants achieved 100% success on simulated use Scenarios 1 and 2 after reviewing the Clinical User Manual, demonstrating effective comprehension and application of IFU information per IEC 62366-1 §5.9. The HCP Knowledge Assessment confirmed comprehension of IFU content (Q1: 94.4% OK, Q2: 100% OK, Q3: 100% OK). HCP Q4 findings regarding intended purpose understanding are addressed in sub-items a and b.

The IFU is developed and maintained as a version-controlled code repository (R-TF-001-006), ensuring content consistency across supported languages and automated verification of structural integrity prior to each release.

The updated section concludes that the IFU is usable and effective for both intended user groups, providing objective evidence per IEC 62366-1 §5.9 and MDR Annex II §6.1(a). Red-lined documentation is provided.

Relevant commits

• c1ee6f6 (2026-03-01, Taig Mac Carthy): Added "Usability of Instructions for Use" section to R-TF-025-007-Summative-Evaluation-Report.mdx with IFU usability results for both user groups.