Clinical strategy FDA 510(k) clearance for Legit.Health US version

Last Updated: March 6, 2026
Document Version: v1.1
Status: Active (Phase 2 - In Progress)

This master document serves as a specialized guide for the AI assistant to elaborate and maintain a "State-of-the-art" / Status Tracking Document that details our FDA 510(k) submission progress. In the absence of Jordi, this Readme.md provides the AI with the necessary rules and context to autonomously generate a document tracking our clinical strategy.

The main sources of information for this task are the documents located in this very folder (Legit.Health-US-version-1-1-0-0), which are explicitly listed below. You must read and understand the information in these source documents first before generating any comprehensive summaries.

Success Result: The ultimate goal is for the AI to generate a comprehensive tracking document where the following is clearly described:

1. Our clinical strategy
2. The current status of the project
3. The estimated schedule of each phase
4. The immediate next steps

Important files

Sources of truth for clinical strategy information:

• Clinical_strategy_FDA_510(k)_Clearance.pdf: This file describes the clinical strategy for the FDA 510(k) clearance of the Legit.Health US version. It includes the rationale behind our strategy, the predicate device we have identified, and the studies necessary to generate the clinical evidence required for our submission, which are three clinical studies: a retrospective standalone performance study, a multi-reader, multi-case prospective study, and a System Reproducibility and Robustness study.
• De_Novo_classification_request_DermaSensor.pdf: This file contains the De Novo classification Request summary for the DermaSensor device, which is the predicate device we have identified for our FDA 510(k) submission. It includes information about clinical evidence generated by the device and the FDA conclusions, which include the implementation of special controls for the mitigation of risks associated with the use of the device.
• dermasensor_case_study_20260127_135817.pdf: This report analyzes the DermaSensor De Novo authorization (DEN230008) to guide us in the design of our regulatory and clinical strategy for the FDA 510(k) clearance. It includes the clinical strategy followed by DermaSensor, the post-market requirement imposed by the FDA and recommendations for us to consider in our clinical strategy. Finally it recommends to conduct a Pre-Submission to confirm our clinical strategy.
• legit_draft_report_20250829_150158.pdf: This draft consultant report provides an analysis of the regulatory strategy for our device. It includes a record of the regulatory pathway followed by other Skin Lesion Analyzer software devices in the USA, including the identification of the predicate device. It also makes a recommendation for the indications of use of our device with different scenarios. This document made us identify the DermaSensor device as the most suitable predicate device for our FDA 510(k) submission, and it also made us consider the possibility of having different indications of use for our device, which we have finally decided to pursue.
• Research_strategy_DermaSensor_Summarize.pdf: This document summarizes the preclinical and clinical investigations conducted by DermaSensor to provide evidence of the device's effectiveness and safety, with the goal of supporting its FDA approval process. DermaSensor carried out 10 different studies, which are categorized into three main groups: 1. Early Clinical Studies (Preclinical); 2. Major Clinical Study and Multi-Reader Multi-Case (MRMC) Studies; and 3. Minor Clinical Studies. These studies have served to design our own clinical strategy and necessary studies to generate the clinical evidence required for our FDA 510(k) submission.
• Brendan_emails: This folder contains the email correspondence with Brendan, which includes discussions about our clinical strategy, the design of our studies, and the interpretation of the evidence generated by DermaSensor. It also includes the email exchanges with Brendan regarding the analysis of the De Novo classification request for DermaSensor and the recommendations for our clinical strategy.

AI Directives & Tone (System Instructions)

This document functions as a system guide for AI assistants working on the FDA 510(k) submission.

• Language & Style: Use strictly American English and formal, professional regulatory language appropriate for FDA documentation (e.g., clinical strategy for a 510(k) submission).
• Mandatory Inquiry: If you need to do something different from what is stated here, or if you feel the need to add more information to this Readme.md document, you must ask Jordi first before proceeding.
• Proactive Questioning: You must ask clarifying questions to perfect and improve the focus of the target document before drafting it.
• Context: This documentation is for internal use to define, track, and execute our clinical strategy for the FDA.
• Formatting: Always use proper Markdown headings and structure. Ensure all < and > characters are escaped as \< and \> to maintain Docusaurus compatibility (as per the repository's global rules).

Glossary & Terminology

• Device Name: Currently referred to as Legit.Health (subject to change during the submission process).
• Intended Use: The official intended use is described in and must be referenced from the dermasensor_case_study_20260127_135817.pdf document. Do not invent or alter this intended use.

Output Locations & Document Generation

When requested to generate the "State-of-the-art" document or create tasks for the 510(k) submission, adhere to the following:

• Target Directory: All clinical validation and strategy files must be stored in: /Users/jordibarrachina/Documents/turborepo/apps/qms/docs/legit-health-plus-version-1-1-0-0/product-verification-and-validation/clinical/Legit.Health-US-version-1-1-0-0/

Current Phase & Milestones

• Current Phase: Phase 1 (Definition of Clinical Strategy) has been completed. We are currently in Phase 2: Pre-Submission Preparation & Submission (March to May 2026).

• Milestones & Schedule:

  • Phase 1: Definition of Clinical Strategy (Completed - March 2026)
  • Phase 2: Pre-Submission (Q-Sub) Preparation & Submission (In Progress - March to May 2026)
  • Phase 3: FDA Answer to Pre-Submission (June to August 2026)
  • Phase 4: Finalize Clinical Study Documentation (August to September 2026)
  • Phase 5: IRB Review and Approval (October 2026)
  • Phase 6: Clinical Studies Execution & Data Collection (November 2026 to February 2027)
  • Phase 7: Data Analysis & Final Clinical Reports (March 2027)
  • Phase 8: FDA 510(k) Compilation and Submission (April to May 2027)

  For a detailed breakdown of each phase, refer to Section 3 of the FDA_510k_Clinical_Strategy_Status.mdx document.

Standard Operating Procedure (SOP) for Generating New Documents

When asked to generate the tracking document or any other clinical/regulatory document, follow this workflow:

1. Review Source Material: Always read the relevant documents in this folder first (listed in the Important files section).
2. Clarify & Ask Questions: Ask the user clarifying questions to ensure the focus of the document is perfect. Do not deviate from these instructions without asking first.
3. Outline & Approve: Outline the proposed document structure and ask the user for approval before drafting the full content.
4. Drafting: Draft the content using formal regulatory American English, explicitly referencing the predicate and our defined clinical strategy where applicable.
5. Formatting Check: Ensure all Markdown is correct and Docusaurus-compatible (escaping < and >).

Autonomous Updates vs. Escalation to Jordi

You may autonomously update the following:

• Current status sections with factual information (e.g., phase completion, milestone achievements)
• Formatting and consistency corrections across documents
• Cross-referencing and hyperlinks between related documents
• Addition of clarifying information based on source documents (PDFs) already available in the folder

You must escalate to Jordi before proceeding with:

• Changes to clinical strategy design or study protocols
• Modifications to the timeline or phase schedule
• Addition of new regulatory requirements or FDA comments
• Changes to predicate device assumptions or regulatory pathway decisions
• Any content modifications not explicitly covered in the source documents
• Updates to the AI Directives or instructions in this Readme