Rapid Evaluation of low Back and neck impairment to Advance Readiness

# Q&A Changes Summary **Removed:** 3 questions (Q2 about STTR eligibility, Q8 about COTS devices, Q15 about imaging-based hybrid architectures). **Renumbered/Consolidated:** Remaining 12 questions shifted positions; former Q3, Q5-Q7, Q9-Q15 became Q2-Q14. **No substantive answer changes:** All retained answers remain identical in content, maintaining prior guidance on D2P2 spine-specific feasibility requirements, multimodal assessment approval, and exclusion of advanced imaging. **Net effect:** Streamlined Q&A by removing topics deemed out-of-scope or already addressed, with no new technical clarifications added.

**Changes to Q&A:** Only Q1 received a substantive answer update. Previously unanswered, it now clarifies that "proof sought" means a feasibility study demonstrating validity and reliability of the solution when evaluating Airmen with low back and neck pain/impairments per topic requirements. All other Q&As (Q2-Q15) remain unchanged. No new questions were added.

# Q&A Changes Summary **New Question Added:** - Q1: Clarifies D2P2 feasibility requirement - seeks examples of acceptable "prior human subjects testing" and "defensible framework and methodology" proof (previously unanswered) **Reordered Questions:** - Original Q1 (STTR eligibility) moved to Q2 - Original Q2-Q15 shifted to Q3-Q16 **No Answer Updates:** All previously answered questions (original Q2-Q15) retain identical responses in new positions. **Key Clarification Sought:** New Q1 directly addresses what constitutes acceptable prior work evidence for D2P2 feasibility—critical given the strict spine-specific human subjects requirement emphasized in Q4.

**Summary of Q&A Changes:** Added 1 new Q&A (Q1) regarding STTR eligibility/application portal availability—directed to SBIR/STTR office POC. Updated answer to integration requirements (now Q2): Clarified that no specific priority targets or complete integrations are expected by Phase II end, but solutions must be designed to support future integrations. Renumbered remaining Q&As (Q2→Q3 through Q15): Previous questions shifted down by 2 positions due to new questions added at top. No substantive changes to technical requirements, feasibility criteria, FDA classification, operator qualifications, or assessment methodology scope.

**NEW QUESTION ADDED:** Q1 (new): Requests clarification on Air Force IT infrastructure compatibility, IL-5/HIPAA readiness architecture, preferred deployment environments (IL-5 cloud options, Windows vs. rugged tablets), and integration with existing EHR/readiness systems. **QUESTIONS RENUMBERED/REORGANIZED:** Previous Q2 (D2P2 feasibility) → now Q2 (same content, awaiting answer) Previous Q3-Q14 → now Q3-Q14 (shifted down one position due to new Q1) **No substantive changes to existing answers.** All prior responses remain identical; only numbering adjusted to accommodate the new infrastructure/IT compatibility question.

**New Q&A Added:** Q1 (new): Addresses D2P2 feasibility requirement - clarifies whether prior "Phase I-type" work in related physiological-readiness domains (non-spine-specific) satisfies the feasibility threshold, or if spine-specific kinematic human-subjects validation must occur pre-Phase II. **Answer pending.** **Structural Changes:** - Renumbered existing Q&As (Q2-Q13 in updated vs. Q1-Q12 previously) - Q12-Q13 in previous version now Q13 (intervention device scope clarification maintained)

Status changed from Pre-Release to Open

# Q&A Changes Summary **Restructured and renumbered entire Q&A section.** Previous Q2 (actionable reports definition) moved to Q2. Previous Q2 (kinematic vs. functional assessment) duplicated as both Q1 and Q3. All other questions renumbered sequentially (Q3-Q12). No substantive answer changes; clarifications remain identical regarding FDA Class II 510(k) requirement, multimodal assessments accepted, advanced imaging excluded, and intervention devices out of scope.

# Q&A Changes Summary **New answers provided to existing questions:** - **Q1:** Clarified "actionable reports" are for the provider to guide treatment decisions - **Q2:** Confirmed kinematic measurement is one approach to functional impairment assessment, not the only path - **Q3:** Specified FDA Class II with 510(k) clearance pathway - **Q4:** COTS mobile devices acceptable if FDA Class II/510(k) compliant - **Q6:** Any optical motion capture system acceptable for validation (not system-specific) - **Q7:** Operators must hold medical licensure/certification with MSK training (clarified scope of qualified personnel) - **Q8:** Declined to provide specific use scenarios to avoid constraining solution approaches **Key clarifications:** FDA Class II/510(k) is mandatory; kinematic approach preferred but non-kinematic approaches considered if technology-specific; multimodal wearable-physiological metrics acceptable (Q9 reiterated); advanced imaging excluded.

Added 8 new Q&As (Q1-Q8) clarifying scope: actionable report format, whether kinematic measurement or functional assessment is the core requirement, FDA classification expectations, acceptability of COTS mobile devices vs. custom hardware, non-kinematic approaches, motion capture validation standards, operator qualifications, and real-world deployment scenarios.

Q1 received a new answer clarifying that multimodal assessment combining portable movement analysis with wearable physiological/neuromuscular metrics is responsive to topic intent. Q2 and Q3 answers remain unchanged, reiterating that advanced imaging and intervention devices are out of scope.

Added 1 new Q&A (Q1) clarifying that multimodal assessment combining portable movement analysis with wearable physiological/neuromuscular metrics is responsive if field-deployable and usable by lower-trained personnel. Previous Q&As renumbered (Q2, Q3).

Q1 was substantially revised to explicitly reject advanced imaging-based structural biomarkers in assessment tools. Q2 (previously Q1) clarified that ergonomic load-redistribution devices are out of scope; funding targets rapid assessment tools for lower-trained professionals, not interventional devices.

This Q&A clarifies whether an ergonomic load-redistribution device with comfort testing qualifies under the funding topic, or if the topic is restricted to diagnostic/assessment systems for measuring low back and neck impairment.

New opportunity: Rapid Evaluation of low Back and neck impairment to Advance Readiness