{"closest_prior_art":[{"name":"FDA validated transfer of digital-health data to a durable electronic repository","overlap":"FDA guidance describes device-originated data and metadata moving through a validated, pre-specified transfer process to a durable repository, with transfer times, originators, audit trails, access controls, and preservation of traceable records.","remaining_difference":"It does not specify a test-scoped ring buffer, immutable range manifests before overwrite, stage/anomaly transfer triggers, batch quarantine and human promotion, or three-way reconciliation against original instrument exports.","source_ids":["SRC4"]},{"name":"emka TECHNOLOGIES IOX2 physiological acquisition platform","overlap":"IOX2 combines high-rate multi-signal physiological acquisition, real-time viewing and analysis, raw-data files, calculated parameters, secure access, study association, and audit records covering actions affecting raw or processed data.","remaining_difference":"The disclosed product workflow does not establish a provisional bounded store whose ranges require manifested disposition, validation-gated promotion to a separate authoritative repository, source hashing, or explicit cross-store reconciliation.","source_ids":["SRC2"]},{"name":"COSMED OMNIA CPET workflow and documented multi-device exercise-test practice","overlap":"OMNIA provides CPET-specific real-time charts, calibration procedures, ECG interfacing, database functions, export, and post-test raw-data editing. A published exercise-test implementation used real-time device views but still required manual start/stop notes, RR-peak correlation, and post-acquisition synchronization checks across devices.","remaining_difference":"Neither source discloses the complete governed buffer-to-repository lifecycle: immutable manifests, transformation-version lineage, promotion or quarantine, overwrite guards, explicit authority labels, and reconciliation of every sequence range against source files.","source_ids":["SRC1","SRC3"]}],"contrastive_claim_falsifier":"The contrast would be falsified by documentation or a reproducible implementation showing that an existing physiological-test system already places every captured range from a bounded live buffer under an immutable pre-overwrite manifest, validates and version-traces transformations, promotes or quarantines reviewed batches, and reconciles sequence ranges, timestamps, calibration identifiers, and hashes against both original instrument files and an authoritative repository.","contrastive_claim_remaining":"Within the retained evidence, the remaining claim is the exercise-test-specific combination of provisional low-latency buffering with mandatory sample-range disposition, validation-gated promotion or quarantine, durable transformation provenance, and explicit buffer/source-file/repository reconciliation. The individual acquisition, synchronization, durable-transfer, and audit components are established or closely adjacent.","experiment_id":"eoa_inverse_innovation_exp13_second_slot_policy60_20260806","gates":{"adequate_source_search":{"rationale":"The bounded search covered the proposal directly, ring/circular/cyclic-buffer and waveform-acquisition terminology, CPET and physiological acquisition products, FDA electronic-record guidance, and combinations involving synchronization, durable transfer, validation, audit trails, provenance, and quarantine. Four opened sources from four publishers were retained, including primary research, official guidance, and two first-party product sources.","source_ids":["SRC1","SRC2","SRC3","SRC4"],"status":"PASS"},"bounded_next_test":{"rationale":"A replay of one completed de-identified test using untouched file copies is limited, reversible, and directly measurable. Prespecified duplicate, missing-range, clock-offset, and calibration-mismatch injections can test detection, latency, manifest completeness, provenance, quarantine behavior, and agreement with an independently prepared reference dataset without changing test conduct or records.","source_ids":["SRC1","SRC2","SRC4"],"status":"PASS"},"distinct_testable_claim":{"rationale":"Existing evidence covers real-time physiological acquisition, CPET databases, synchronization, raw-data handling, audit trails, and validated transfer to durable repositories, but does not disclose the full governed range-manifest, promotion/quarantine, and three-way reconciliation combination. Those missing elements yield observable pass/fail conditions.","source_ids":["SRC1","SRC2","SRC3","SRC4"],"status":"PASS"},"no_obvious_safety_or_authority_stop":{"rationale":"The authorized first step uses de-identified copies in an isolated shadow workflow, preserves original files, makes no protocol or participant-record changes, and keeps provisional data out of diagnosis and authoritative reports. This is consistent with risk-based validation, access control, secure transfer, traceability, and record-preservation concerns in FDA guidance. Supervisor authority and halt conditions remain explicit.","source_ids":["SRC4"],"status":"PASS"},"supported_problem":{"rationale":"The exercise-test study demonstrates heterogeneous instruments, simultaneous live views, manual timing notes, post-acquisition RR-peak correlation, synchronization fine-tuning, noise-related exclusions, and manual measurement alignment. Product sources independently show demand for real-time physiological viewing, synchronization, storage, calibration, data integrity, and audit capabilities. The frequency and severity of unresolved discrepancies are not quantified, so support is partial rather than complete.","source_ids":["SRC1","SRC2","SRC3"],"status":"PASS"}},"prior_art_disposition":"ADJACENT_PRIOR_ART","problem_evidence":{"finding":"The live-versus-analysis tension is visible: an actual graded exercise workflow monitored several signals in real time yet subsequently relied on manual timing records, correlation-based alignment, fine-tuning, and signal-quality exclusions. Commercial systems address substantial portions through integrated real-time acquisition, calibration, storage, post-test processing, and audit controls, but the sources do not establish how often current workflows lose samples or fail provenance reconstruction.","source_ids":["SRC1","SRC2","SRC3"],"status":"PARTLY_SUPPORTED"},"research_id":"eoa_inverse_innovation_exp13_light_screen_20260806","schema_version":1,"screen_id":"E13P019","screen_survival":true,"search_lanes":{"component_combination":{"no_result_note":null,"queries":["biomedical instrument data staging validation promotion quarantine provenance","physiological data acquisition ring buffer validated repository provenance live monitoring","exercise physiology data acquisition audit trail real-time analysis raw data"],"source_ids":["SRC1","SRC2","SRC3","SRC4"]},"direct_problem_and_intervention":{"no_result_note":null,"queries":["graded exercise test multiple device data synchronization timestamps metabolic cart ECG data integration study","physiological signal ring buffer acquisition durable storage","physiological data acquisition staging validation quarantine provenance repository software"],"source_ids":["SRC1","SRC2","SRC4"]},"products_practices_and_standards":{"no_result_note":null,"queries":["site:cosmed.com OMNIA CPET software real time data synchronization export database","physiological data acquisition IOX2 real-time audit trail raw data","site:fda.gov electronic systems electronic records clinical investigations audit trail durable repository"],"source_ids":["SRC2","SRC3","SRC4"]},"synonyms_and_historical_terms":{"no_result_note":null,"queries":["circular buffer physiological data acquisition waveform","physiological signal ring buffer acquisition durable storage","clinical physiological waveform acquisition buffer audit trail standard provenance","continuous acquisition cyclic buffer data logging physiological signals"],"source_ids":["SRC2","SRC4"]}},"sources":[{"claims_supported":["A graded exercise study used a metabolic analyzer, ECG, wearable sensor, heart-rate monitor, workload equipment, and real-time raw-signal inspection.","Cross-device analysis required manually noted start/stop times, RR-peak correlation, and subsequent synchronization fine-tuning.","Some participant data were excluded for low signal-to-noise ratio, and manually recorded measurements were aligned to physiological signals."],"publisher":"Frontiers Media SA","source_id":"SRC1","source_type":"PRIMARY_RESEARCH","title":"Blood Pressure Response and Pulse Arrival Time During Exercise Testing in Well-Trained Individuals","url":"https://www.frontiersin.org/journals/physiology/articles/10.3389/fphys.2022.863855/full"},{"claims_supported":["IOX2 acquires, analyzes, views, and stores physiological data while supporting high-rate real-time processing and review.","The platform links synchronized streams to raw files and supports both physical and calculated signals.","Optional GLP functions provide controlled access, electronic signatures, study association, and secure audit records for actions affecting raw or processed data."],"publisher":"emka TECHNOLOGIES","source_id":"SRC2","source_type":"FIRST_PARTY_PRODUCT","title":"Physiological data acquisition & analysis — IOX2 software","url":"https://www.emkatech.com/product/iox2-software/"},{"claims_supported":["OMNIA supplies CPET-specific real-time and post-test dashboards, calibration procedures, ECG interfacing, protocol support, and database import/export.","The product permits post-test filtering or editing of raw data and calculation of derived CPET parameters."],"publisher":"COSMED","source_id":"SRC3","source_type":"FIRST_PARTY_PRODUCT","title":"The new OMNIA 1.3 software release: now also includes metabolic testing modules","url":"https://www.cosmed.com/en/news/company/1015-the-new-omnia-1-3-software-release-now-also-includes-metabolic-testing-modules"},{"claims_supported":["FDA recommends that device-recorded data and associated metadata be transferred by a validated process to a durable electronic repository under a pre-specified plan.","Transfer timing belongs in the audit trail, and device origin, recording time, and participant association should be retained as repository metadata.","Electronic records and metadata should remain secure, traceable, reconstructable, access-controlled, and protected against obscuring prior information."],"publisher":"U.S. Food and Drug Administration","source_id":"SRC4","source_type":"OFFICIAL_GUIDANCE","title":"Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers","url":"https://www.fda.gov/media/166215/download"}],"world_novelty_boundary":"This coarse public-web screen found adjacent implementations and guidance but no retained source disclosing the complete proposed combination. It cannot establish world novelty, patentability, freedom to operate, market size, expert acceptance, implementation feasibility beyond the bounded replay, or realized safety or analytical value."}