---
title: "PCCP Diff Checker · amendment review · AI SaMD"
description: "Paste two Predetermined Change Control Plan markdowns and get a side-by-side diff with section-level summary for PCCP amendments."
lang: en
json-ld: |
  [
    {
      "@context": "https://schema.org",
      "@graph": [
        {
          "@type": "WebSite",
          "@id": "https://ai-samd.com/#website",
          "url": "https://ai-samd.com/",
          "name": "AI SaMD Playbook",
          "description": "Working reference for regulating AI/ML Software as a Medical Device: FDA, EU AI Act, MHRA, Health Canada and NMPA guidance, model risks, and cybersecurity for RA/QA teams.",
          "inLanguage": "en"
        },
        {
          "@type": "Organization",
          "name": "Blue Goat Cyber",
          "url": "https://bluegoatcyber.com"
        }
      ]
    },
    {
      "@context": "https://schema.org",
      "@type": "BreadcrumbList",
      "itemListElement": [
        {
          "@type": "ListItem",
          "position": 1,
          "name": "Home",
          "item": "https://ai-samd.lovable.app/"
        },
        {
          "@type": "ListItem",
          "position": 2,
          "name": "PCCP Diff Checker",
          "item": "https://ai-samd.lovable.app/pccp-diff"
        }
      ]
    }
  ]
---

[AI SaMD Playbook ](/)

Sections[Crosswalk](/#crosswalk)Tools

Search Ctrl K[Talk to us →](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session)

[Back to AI SaMD Playbook](/)Amendment tool · for PCCP revisions & FDA AI rounds 

# PCCP _diff_ checker

Paste the cleared PCCP on the left and the amended version on the right. Get a side-by-side diff with a section-level summary so you can quickly answer the reviewer's first question · "what actually changed?".

Original PCCP (cleared)

\# PCCP · DiabetesScreen v1.0 ## Description of Modifications - Periodic retraining every 6 months on new institutional data. - Threshold for positive prediction held at 0.62. ## Modification Protocol - Acceptance: sensitivity ≥ 0.85, specificity ≥ 0.90 on held-out test set. - Bias monitored across 5 self-reported race groups. ## Impact Assessment - No change to intended use. - No change to clinician workflow.

Amended PCCP (proposed)

\# PCCP · DiabetesScreen v1.1 ## Description of Modifications - Periodic retraining every 3 months on new institutional data. - Threshold for positive prediction held at 0.62. - Added support for ingesting de-identified Epic FHIR observations. ## Modification Protocol - Acceptance: sensitivity ≥ 0.87, specificity ≥ 0.90 on held-out test set. - Bias monitored across 5 self-reported race groups and 4 age bands. - Drift threshold: subgroup AUROC drop > 0.03 triggers investigation. ## Impact Assessment - No change to intended use. - Workflow: adds inline confidence band in EHR side panel.

Changes +7 added −5 removed 

Swap Copy Download report DOCX

Section-level summary

-   PCCP · DiabetesScreen v1.0 +0  /  −1 
-   PCCP · DiabetesScreen v1.1 +1  /  −0 
-   Description of Modifications +2  /  −1 
-   Modification Protocol +3  /  −2 
-   Impact Assessment +1  /  −1 

Original Amended 

\# PCCP · DiabetesScreen v1.0

\# PCCP · DiabetesScreen v1.1

\## Description of Modifications

\## Description of Modifications

\- Periodic retraining every 6 months on new institutional data.

\- Periodic retraining every 3 months on new institutional data.

\- Threshold for positive prediction held at 0.62.

\- Threshold for positive prediction held at 0.62.

\- Added support for ingesting de-identified Epic FHIR observations.

\## Modification Protocol

\## Modification Protocol

\- Acceptance: sensitivity ≥ 0.85, specificity ≥ 0.90 on held-out test set.

\- Bias monitored across 5 self-reported race groups.

\- Acceptance: sensitivity ≥ 0.87, specificity ≥ 0.90 on held-out test set.

\- Bias monitored across 5 self-reported race groups and 4 age bands.

\- Drift threshold: subgroup AUROC drop > 0.03 triggers investigation.

\## Impact Assessment

\## Impact Assessment

\- No change to intended use.

\- No change to intended use.

\- No change to clinician workflow.

\- Workflow: adds inline confidence band in EHR side panel.

Runs entirely in your browser · no PCCP content leaves this page.

© 2026 AI SaMD Playbook · Sponsored by Blue Goat Cyber

[Crosswalk](/crosswalk)[Colophon](/colophon)

Editorial reference only. Not legal or regulatory advice.