Response

a. We acknowledge that R-TF-025-007 (Summative Evaluation Report) did not include the root cause analysis and residual risk assessment committed to in R-TF-025-004, §14.7 (Data Analysis) and required by EN 62366-1 §5.9. This documentation gap has been addressed. R-TF-025-007 has been updated with two new sections: "Root Cause Analysis of Observed Use Problems" and "Residual Risk Assessment." Red-lined documentation is provided.

During the root cause analysis process, all non-OK observations were reviewed against the original handwritten participant responses. Two observations were found to have been scored more conservatively than warranted upon detailed review:

• HCP-013, Q4 (originally scored CC, reclassified to OK): The handwritten response in Spanish reads "PUEDE AYUDAR MUCHO AL DIAGNÓSTICO, INCLUSO SIN SER UN DIAGNÓSTICO POR SI MISMO" — "can help a lot with diagnosis, even without being a diagnosis itself." The initial transcription misread the handwritten "sin" (without) as "si" (if), creating ambiguity. Upon review, the participant correctly stated the device is not a diagnosis itself.
• HCP-014, Q2 (originally scored UD, reclassified to OK): The response "Muy baja, cerca del 0%" ("Very low, near 0%") is qualitatively correct for the displayed malignancy probability (0.08%). The participant demonstrated correct understanding of the report output.

After reclassification, 6 non-OK observations remain (1 use error, 3 close calls, 2 use difficulties), all in Scenario 3 (Knowledge Assessment). Scenarios 1 and 2 (simulated use) achieved 100% success (36/36).

The root cause analysis examined each use problem individually and concluded that none indicate a systematic user interface design issue:

• The 3 close calls (all Q4) demonstrate self-correction ability. Per IEC 62366-1:2015+AMD1:2020, close calls are use difficulties where the user recovers before committing a use error — they are positive evidence of error recognition and recovery, not use errors.
• The 2 use difficulties (Q1 and Q4) reflect challenges with the written assessment format rather than fundamental misunderstanding of the device's role. Both participants used the device correctly during simulated use scenarios.
• The single use error (HCP-008, 1/18 = 5.6%) is an isolated, participant-specific finding. The same participant also had a use difficulty on Q1, and no other participant provided an unqualified affirmative response on Q4.

The residual risk assessment concludes that residual risk is acceptable:

• Further risk reduction is not practical. The device employs inherently safe design (clinical decision support architecture that presents probabilistic outputs requiring physician interpretation — the device cannot autonomously generate or communicate a diagnosis) and information for safety (IFU and labeling explicitly state the device is not intended for diagnosis). A voluntary IFU enhancement (a dedicated safety information callout in the Clinical User Manual) has been implemented to further increase the prominence of the non-diagnostic statement.
• Benefits outweigh residual risks. The clinical benefit of timely skin condition assessment outweighs the residual risk of a single participant (5.6%) misunderstanding the non-diagnostic nature in a written assessment, given that the device architecture prevents autonomous diagnostic action, all participants correctly used the device during simulated scenarios (100% success), and the physician retains independent clinical judgment in all use cases.
• No user interface design modifications are required. No additional summative evaluation is required.

The assessment of risks R-CGQ and R-TBN in relation to these findings is addressed in the response to sub-item b.

Relevant commits

• d051147 (2026-03-01, Taig Mac Carthy): Added "Root Cause Analysis of Observed Use Problems" and "Residual Risk Assessment" sections to R-TF-025-007-Summative-Evaluation-Report.mdx. Corrected two participant scores in usability_test_responses.json (HCP-013 Q4: CC→OK, HCP-014 Q2: UD→OK).
• 875b579 (2026-03-01, Taig Mac Carthy): Minor markdown formatting fixes in R-TF-025-007-Summative-Evaluation-Report.mdx.
• 3045fa6 (2026-03-01, Taig Mac Carthy): Created apps/eu-ifu-mdr/versioned_docs/version-1.1.0.0/clinical-user-manual/important-safety-information.mdx and fixed three spelling errors in precautions.mdx. Implements the "voluntary IFU enhancement" referenced in the response.
• 7804ad3 (2026-03-01, Taig Mac Carthy): Added "Effectiveness of Information for Safety" section to R-TF-025-007-Summative-Evaluation-Report.mdx.