CEP row rewrite — MAN_2025 Confirmatory-Phase row

Internal artefact for task-3b13. This is the verbatim replacement markup that was applied to R-TF-015-001-Clinical-Evaluation-Plan.mdx at the MAN_2025 row of the Confirmatory Phase pivotal-investigations table. Applied 2026-04-21.

Before (stale)

Five Planned strings:

**State of process**: Planned
**Initiation date**: Planned
**Inclusion period**: Planned. This study will include a minimum of 5 dermatologists to assess 149 images of skin conditions representing Fitzpatrick phototype V-VI presentations.
**Completion date**: Planned
**Date of the study report**: Planned

After (factual)

• **State of process**: Completed
• Milestones cell (Type-of-study column kept unchanged except for State of process flipped to Completed):
  • **Initiation date**: January 21, 2026
  • **Inclusion period**: January 21, 2026 to April 17, 2026
  • Reader-count prose: "This study included 16 healthcare professionals (primary analysis cohort; 19 enrolled, 3 screen failures) to assess 149 images of Fitzpatrick phototype V-VI skin presentations."
  • **Sample-size rationale**: two-sided McNemar paired-binary power calculation (baseline 60 %, target 70 %, α = 0.05, 1 − β = 0.80, 25 % discordant proportion) requiring approximately 200 paired observations; the conservative 5-reader × 149-image floor provides 745 paired observations (effective N ≈ 460 at ICC 0.15). Full derivation in R-TF-015-004 §Sample size.
  • **Reference standard**: published atlas diagnosis encoded as ICD-11, established prior to and independently of the investigation, consistent with the methodology of SAN_2024, BI_2024 and PH_2024; see R-TF-015-004 §Reference standard (ground truth).
  • **Completion date**: April 17, 2026
  • **Date of the study report**: as recorded on the signature block of the signed Clinical Investigation Report (R-TF-015-006 MAN_2025 instance).

Primary objectives, secondary objectives and acceptance-criteria cells were left unchanged.

Design choices baked in

• Initiation date: the data-collection start date (21 January 2026) was chosen, matching the convention used in the SAN_2024 / BI_2024 / PH_2024 / MC_EVCDAO_2019 / IDEI_2023 rows of the same table. The planning-phase start (October 2025) was rejected because no other completed row uses the pre-data-collection planning phase.
• Reader count: the CIP-time aspirational "≥ 5 dermatologists" was replaced with the CIR's actual 19 enrolled / 16 primary cohort / 3 screen failures.
• Completion date: the data-lock date (17 April 2026).
• Date of the study report: cross-reference to the CIR's <Signature /> block (no fixed calendar date in the MDX source; consistent with the CIR's own convention at R-TF-015-006 line 58).
• Sample-size and reference-standard summaries: added per the task brief's recommendation and per the do-we-need-this.md "Recommended" scope. The full power calculation derivation stays in the CIP — the CEP row carries only a summary with a CIP cross-reference.
• Pillar 3 §4.4 at Rank 11 anchoring: preserved verbatim. This is a hard requirement from the celine-clinical-consultant methodological framework (Celine Horiana consultation, 2026-04-17) — the MRMC MAN_2025 row must not drift into Pillar 2.
• Cross-references: all named-identifier-only (R-TF-015-004 MAN_2025 instance, R-TF-015-006 MAN_2025 instance). No internal folder paths, no CLAUDE.md references, no BSI ticket IDs.

Ripple edits made outside the CEP row

Summarised here for traceability; full detail is in the plan at /Users/taigmaccarthy/.claude/plans/let-s-takle-the-task-inherited-pebble.md.

• CEP line 955 — Phase-3 mermaid diagram node MAN["MAN_2025: Fitzpatrick phototypes V-VI (planned)"] → drop (planned) suffix.
• CEP line 39 — portfolio-status prose: "Investigations listed with status 'Planned' are governed by this Plan for execution..." rewritten so the "Planned" antecedent is non-empty under the new table state (clause now explicitly scopes to PMCF-phase investigations).
• r-tf-015-013-statistical-summary.mdx — scope sentence (line 11), table-cell state marker (line 24), aggregate total (line 26, 878/9 → 1,027/10), §MAN_2025 body section (heading, status, reader panel, caution admonition, pathology table refreshed to the CIR's 28-condition × 149-image set with ICD-11 codes), and four supporting-studies footnotes all synchronised with the completed state.

Cross-reference audit

No internal-infrastructure references were introduced into audit-visible documents. Every cross-reference used in the new CEP row text and the r-tf-015-013-statistical-summary.mdx edits is an audit-visible identifier (R-TF-015-004, R-TF-015-006) with a section name.