Rapid Evaluation of low Back and neck impairment to Advance Readiness

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