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Overview

ARKA Health, Inc. maintains a Pre-Submission (Q-Sub) package (version 1.0, June 9, 2026) requesting FDA written feedback on two software functions: ARKA-CLIN, designed to meet the four Non-Device Clinical Decision Support criteria under FD&C Act §520(o)(1)(E), and ARKA-INS, administrative-support software under §520(o)(1)(A). A reference-image viewer is documented as a separate display function outside the scope of that submission.

Package manifest: docs/regulatory/q-sub-draft/00_README.md · Final PDFs: docs/regulatory/q-sub-final/

Function map

Per the multiple-function analysis (Document 05), ARKA is a single platform with distinct software functions assessed separately:

• ARKA-CLIN — imaging-appropriateness recommendations from structured data; ranked, evidence-cited options with reviewable basis. Regulatory basis presented: §520(o)(1)(E) Non-Device CDS (four criteria). Status requested: FDA concurrence (Question 1).
• ARKA-INS — benefit-eligibility determination, claims-based utilization/cost analysis, prior-authorization documentation (Da Vinci CRD/DTR/PAS), cost transparency, and scheduling. Regulatory basis presented: §520(o)(1)(A) administrative support. Status requested: FDA concurrence (Question 2).
• Reference viewer — displays previously acquired DICOM studies as non-diagnostic thumbnails. Documented as out of scope, walled off by docs/SCOPE_BOUNDARY.md and CI import guards.

ARKA-CLIN (Non-Device CDS)

Intended use (Document 03): ARKA-CLIN is intended for licensed health care professionals to support selection of clinically appropriate diagnostic imaging using structured clinical data. It presents ranked, evidence-cited imaging options drawn from published clinical guidelines and peer-reviewed literature, with the basis available for independent review. It does not acquire, process, or analyze medical images or physiological signals; does not provide time-critical alerts or triage; and does not place, cancel, or block orders.

Architecture (Document 02): rules-first engine — every recommendation is anchored to a published guideline; if no guideline-anchored rule fires, ARKA-CLIN returns no card. Optional XGBoost refinement with SHAP is secondary and labeled; the system falls back to rules-only output when the model is unavailable. Inputs are structured FHIR R4 prefetch only; CI guards fail the build if image- or signal-processing code enters in-scope CDS paths.

Open FDA questions (Document 04) include concurrence on Non-Device CDS status, change-control expectations for the rule library and model weights, and sufficiency of current synthetic validation evidence (~74% three-class accuracy on a synthetic, ACR-aligned cohort per Document 04 — not presented as a clinical-performance claim).

ARKA-INS (administrative support)

ARKA-INS is intended for health care providers and qualified staff to determine health-benefit eligibility, analyze historical claims data, support prior-authorization documentation, and present cost-transparency and scheduling information — administrative functions under §520(o)(1)(A), not clinical diagnosis or treatment recommendations (Document 03). Detailed feature-level support is in Document 06 (06_INS_administrative_support_memo.md).

Supporting evidence

Attachments referenced in the Q-Sub package manifest:

• Model card — ml-service/MODEL_CARD.md (Criteria 2 and 4)
• Scope boundary — docs/SCOPE_BOUNDARY.md (Criterion 1; viewer fenced out of CDS)
• CI enforcement — .github/workflows/go-live.yml, scripts/regulatory-checks.ts, scripts/lint-scope-boundary.ts, scripts/lint-cards.ts
• Sandbox screenshots (5) — docs/regulatory-evidence/sandbox-screenshots/
• Clinical sign-off log — docs/CLINICAL_SIGN_OFF_LOG.md (pre-filing gate: in progress per manifest)
• On-card FDA disclosure (v1.2.0) — lib/compliance/fda-disclosure.ts
• Render health snapshot — docs/regulatory-evidence/render-health-2026-05-26.json (model loaded, catalog hashes recorded)

Pre-filing gates

From the Q-Sub package manifest — complete before submitting:

1. Clinician sign-off — IN PROGRESS. At least one licensed clinician must review the rule library, citations, feature catalogue, and card language and sign a dated entry in docs/CLINICAL_SIGN_OFF_LOG.md.
2. CDRH Portal account registered under the sponsor contact on file.
3. PreSTAR2 v3.0 completed with "eSTAR COMPLETE" status before upload.
4. Recommended: run FDA's Digital Health Policy Navigator for ARKA-CLIN and ARKA-INS separately and retain screenshots.

This package requests FDA feedback; it must never be described as FDA approval, clearance, registration, or endorsement.

Documentation

Full Q-Sub draft markdown: docs/regulatory/q-sub-draft/ · Final PDFs: docs/regulatory/q-sub-final/