Response

b. R-TF-025-007 (Summative Evaluation Report) has been updated with a dedicated "Assessment of Related Risks" section within the Residual Risk Assessment, which evaluates the effectiveness of R-CGQ and R-TBN mitigation using the summative evaluation findings.

After scoring verification (see sub-item a), Q4 non-OK responses total 5/18 (27.8%): 1 use error (5.6%), 3 close calls (16.7%), and 1 use difficulty (5.6%). Per IEC 62366-1:2015+AMD1:2020, close calls are use difficulties where the user recovers before committing a use error. Including self-corrections, 17/18 (94.4%) of HCP participants demonstrated correct understanding that the device is not intended for diagnosis. The root cause analysis concluded that no non-OK response indicates a systematic user interface design issue (R-TF-025-007, "Root Cause Analysis of Observed Use Problems"). The residual risk assessment concluded that residual risk is acceptable (R-TF-025-007, "Residual Risk Assessment").

R-TF-013-002 (Risk Management Record) has been updated:

• R-CGQ ("Whole device is wrongly used or is not used as intended"): User group expanded from "ITP" to "ITP, HCP" to reflect that the hazardous situation applies to both intended user groups. The verification of effectiveness (T-TF-025-007 Summative Evaluation Report) now covers both user groups, with HCP-specific findings documented in R-TF-025-007, "Assessment of Related Risks." All 18 HCP participants achieved 100% success in simulated use scenarios, confirming correct operational use. The risk control measures — inherently safe design (Option A: clinical decision support architecture that cannot autonomously generate a diagnosis) and information for safety (Option C: IFU and labeling) — are effective for both user groups.
• R-TBN ("Insufficient label information to understand the device intended use, version"): User group expanded from "ITP" to "ITP, HCP." Summative evaluation (T-TF-025-007) added as additional verification of effectiveness alongside internal/external audits. The Knowledge Assessment directly tests whether label and IFU information is sufficient for users to understand intended use, providing objective evidence of effectiveness: 100% for ITPs and 94.4% for HCPs (including self-corrections per IEC 62366-1).

A voluntary IFU enhancement has been implemented to further strengthen the information for safety (see sub-item d).

Red-lined documentation is provided for R-TF-025-007 and R-TF-013-002.

Relevant commits

• d051147 (2026-03-01, Taig Mac Carthy): Added "Root Cause Analysis of Observed Use Problems" and "Residual Risk Assessment" sections (including "Assessment of Related Risks" subsection evaluating R-CGQ and R-TBN) to R-TF-025-007-Summative-Evaluation-Report.mdx.
• 5a8e4a9 (2026-03-01, Taig Mac Carthy): Updated R-TF-013-002.json to expand user groups for R-CGQ and R-TBN from "ITP" to "ITP, HCP" and added summative evaluation (T-TF-025-007) as verification of effectiveness. Updated types.ts in the RiskManagement component.