{ "id": "AIBD-0300", "title": "Apple Watch Series 11 breathing-disturbance notifications send a 79-year-old to his cardiologist; morning watch ECGs show AF after “elevated” nights and CPAP starts without polysomnography", "summary": "Fukuoka case (Cureus, 26 May 2026): sleep-apnoea notifications prompted consultation; watch ECGs showed AF only after “elevated” breathing-disturbance nights; CPAP under way, no polysomnography.", "date_observed": "2026-05-26", "date_basis": "source publication", "date_precision": "day", "benefit_status": null, "source_collection": null, "source_entry": null, "account": "Maruyama (Haradoi Hospital, Fukuoka), Hieda and Fukata reported a case in Cureus on 26 May 2026. The consultation is undated. The patient is a 79-year-old Japanese man with hypertension, dyslipidemia, type 2 diabetes and symptomatic paroxysmal atrial fibrillation (AF). A 12-lead electrocardiogram (ECG) had documented it a decade earlier. After retirement no paroxysms were documented by ambulatory or standard ECG, and pulsed-field ablation was deferred. Some months after he began wearing an Apple Watch Series 11 paired with an iPhone 15 Pro, he consulted the authors. He asked about notifications of nocturnal “respiratory disturbance”. He activated the watch ECG every morning and evening. AF paroxysms were detected repeatedly on mornings after nights the watch rated breathing disturbance “elevated”. They were not detected after “not elevated” nights, and they terminated by evening. He is undergoing CPAP therapy, and pulsed-field ablation will be considered depending on its effect on the paroxysms. No polysomnography was performed. The authors state that watch-detected breathing disturbance is not equivalent to the apnea-hypopnea index. They state that the watch ECG cannot fully substitute for conventional ECG, and that the notification algorithm “was reportedly developed using advanced machine learning”. The Food and Drug Administration (FDA) cleared Apple's Sleep Apnea Notification Feature under 510(k) K240929 on 13 September 2024. Apple's 510(k) submission says that it uses a deep learning algorithm on Apple Watch accelerometer data, analyzed in 30-day windows. It was trained on over 11,000 nights with polysomnography or home sleep-test reference. No treatment outcome is reported.", "category": "benefit created", "unexpected": false, "purpose": "The notification feature is built to identify patterns of breathing disturbance suggestive of moderate-to-severe sleep apnea and tell the user. The ECG app is built to record and classify single-lead rhythm. Both were used as designed.", "system": "Apple Watch Sleep Apnea Notification Feature (breathing-disturbance notifications) and the ECG app", "model_version": "Apple Watch Series 11 with iPhone 15 Pro", "developer": "Apple", "deployer": null, "location": "Fukuoka, Japan", "domain": "Healthcare (cardiology; sleep medicine)", "segment": "Consumer wearables", "benefit_type": "Improved Physical Health", "taxonomy_note": null, "registry_ids": {}, "ratings": [ { "group": "personal", "depth": 1, "reason": "A man whose AF was thought quiescent learned that paroxysms recur after disturbed-breathing nights, and he started CPAP. No confirmed sleep-apnea diagnosis and no treatment effect are reported." } ], "ai_role": { "status": "assessed", "statement": "The notification feature's deep-learning model, described in Apple's submission to FDA, flagged elevated breathing disturbance and brought the patient to the clinic. His own morning ECG recordings, read by the authors, showed the AF paroxysms. The paper does not state separately what the ECG app's classifier reported. Clinicians chose CPAP and deferred ablation. The treating authors report the clinical episode. Apple supplies the technical description and validation in its 510(k) summary. FDA's clearance is a separate regulatory decision and does not verify this patient's benefit." }, "evidence": [ { "kind": "case report", "citation": "Maruyama T, Hieda M, Fukata M (2026). Smartwatch-Detected Atrial Fibrillation on the Morning After a Nocturnal Sleep-Disordered Breathing Notification: A Case Report. Cureus 18(5):e109701 (PMC13301138). Case Presentation, Figure 2, Discussion, and references 12–14.", "title": "Smartwatch-Detected Atrial Fibrillation on the Morning After a Nocturnal Sleep-Disordered Breathing Notification: A Case Report", "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC13301138/", "date": "2026-05-26", "written_by": "independent", "quote": "the smartwatch repeatedly detected AF paroxysms the following morning, only after the smartwatch had issued a breathing-disturbance notification during sleep." }, { "kind": "regulatory document", "citation": "Apple Inc. (2024). Sleep Apnea Notification Feature: 510(k) Summary, K240929, device description and performance testing, pp. 2 and 5–7, filed with the FDA. File includes FDA's September 13, 2024 substantial-equivalence letter.", "title": "510(k) Summary K240929: Sleep Apnea Notification Feature (SANF)", "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K240929.pdf", "date": "2024-09-13", "written_by": "makers", "quote": "SANF includes a deep learning algorithm to identify breathing disturbances using accelerometer sensor data from Apple Watch." } ], "replication": { "produced_by": [ "Nightly watch wear with the sleep-apnea notification feature active, plus the owner's habit of recording a watch ECG every morning and evening", "A known history of paroxysmal AF that made the morning traces interpretable to his cardiologists", "Access to a clinic willing to act on watch data (CPAP started without polysomnography)" ], "must_hold": [ "The user completes onboarding and wears the watch during sleep, since the feature evaluates 30-day windows opportunistically", "Clinicians confirm with conventional ECG and polysomnography, which the authors say the watch cannot replace and which was not done here" ], "echoes": [] }, "paired_incident": null, "headline": "Apple Watch breathing alerts send a 79-year-old to CPAP therapy", "metric": null, "comparator": { "against": "ambulatory monitoring and standard 12-lead ECG, which had documented no paroxysms since his retirement", "before": "AF paroxysms were not documented by ambulatory monitoring or standard ECG", "after": "AF paroxysms were detected repeatedly in the morning after notification of nocturnal “elevated” breathing disturbance, but not in the morning after nights when breathing disturbance was “not elevated”", "basis": "measured", "quote": "AF paroxysms were not documented by ambulatory monitoring or standard ECG (Figure 1B), and we deferred pulsed-field ablation for his AF paroxysms.", "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC13301138/" }, "later": { "status": "unknown", "date": null, "note": "The May 2026 report says CPAP therapy is under way and ablation will depend on its effect; no later outcome was found.", "quote": null, "url": null }, "value": null, "developer_country": "United States", "deployer_country": null, "unrated_because": null, "brief_notes": null, "brief": null, "revisions": [ { "date": "2026-10-20", "change": "Record drafted from the cited sources.", "source": null, "editor": "AIBD" }, { "date": "2026-10-21", "change": "Benefit type set to Improved Physical Health under Trustible's full taxonomy of 23 types; it was Improved Accessibility among the six first used.", "source": "https://trustible.ai/post/a-framework-for-measuring-the-benefits-of-ai/", "editor": "AIBD" }, { "date": "2026-10-21", "change": "Added what the benefit is measured against from the cited sources.", "source": "https://pmc.ncbi.nlm.nih.gov/articles/PMC13301138/", "editor": "AIBD" }, { "date": "2026-10-21", "change": "Country of the developer added from the organization's own site or a registry.", "source": "https://en.wikipedia.org/wiki/Apple_Inc.", "editor": "AIBD" }, { "date": "2026-10-21", "change": "Prose pass: a rating reason, account, purpose, the replication conditions, the system's part rewritten in shorter sentences with abbreviations expanded; facts, figures and quotations unchanged.", "source": null, "editor": "AIBD" }, { "date": "2026-10-24", "change": "Consolidated three excerpts of the clinical report and two excerpts of the 510(k) file into two sources. Followed the case's technical references to Apple's original white paper and submission. Corrected the prose to identify that the FDA-hosted technical summary was written by Apple. Preserved that CPAP began but no treatment outcome or polysomnographic confirmation was reported.", "source": "https://pmc.ncbi.nlm.nih.gov/articles/PMC13301138/", "editor": "AIBD" } ], "confidence": "studied", "shade": "high", "claim_status": "Independently studied", "claim_basis": "Sources: one independent case report and the makers' regulatory document. The cited evidence includes no finding by a regulator or court.", "profile": { "case_id": "AIBD-0300", "catalog_version": "1.0.0", "source_fingerprint": "3c00ba05fd9e3361ace72306c00b7428276417fec489bdf1bb70cf22ba9853cd", "collection_refs": [ { "collection_id": "aibd", "version": "snapshot-8bf7cfec9cb185aa" }, { "collection_id": "aibd", "version": "2026-10-25" }, { "collection_id": "querist", "version": "2026-10-25" }, { "collection_id": "viator", "version": "2026-10-25" } ], "source_ids": [ "AIBD-0300-source-0001", "AIBD-0300-source-0002" ], "families": { "strategic assessments": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial", "record_ids": [] }, "evaluations": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial", "record_ids": [] }, "monetary observations": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial", "record_ids": [] }, "institutional decisions": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial", "record_ids": [] } }, "fields": { "actors[]": { "state": "value_present", "value": { "kind": "record_fields", "fields": { "developer": "Apple" } }, "provenance": { "kind": "legacy_record", "basis": "Preserved from the existing AIBD record; external sources were not rechecked.", "record_fields": [ "developer" ], "source_refs": [] }, "review_state": "record_mapped", "coverage": "partial" }, "actors[].ownership_control": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial" }, "ai_contribution": { "state": "value_present", "value": { "kind": "record_fields", "fields": { "ai_role": { "status": "assessed", "statement": "The notification feature's deep-learning model, described in Apple's submission to FDA, flagged elevated breathing disturbance and brought the patient to the clinic. His own morning ECG recordings, read by the authors, showed the AF paroxysms. The paper does not state separately what the ECG app's classifier reported. Clinicians chose CPAP and deferred ablation. The treating authors report the clinical episode. Apple supplies the technical description and validation in its 510(k) summary. FDA's clearance is a separate regulatory decision and does not verify this patient's benefit." } } }, "provenance": { "kind": "source_review", "basis": "Updated only the mapped fields affected by this source review. Other mapped content and review decisions are preserved.", "record_fields": [ "ai_role" ], "source_refs": [ "AIBD-0300-source-0001", "AIBD-0300-source-0002" ], "reviewed_on": "2026-10-24" }, "review_state": "reviewed", "coverage": "partial", "display": { "answer": "Sleep-apnea notifications prompted the patient to seek care. Clinicians interpreted his morning ECG recordings and chose CPAP treatment. 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"value_present", "value": { "kind": "record_fields", "fields": { "account": "Maruyama (Haradoi Hospital, Fukuoka), Hieda and Fukata reported a case in Cureus on 26 May 2026. The consultation is undated. The patient is a 79-year-old Japanese man with hypertension, dyslipidemia, type 2 diabetes and symptomatic paroxysmal atrial fibrillation (AF). A 12-lead electrocardiogram (ECG) had documented it a decade earlier. After retirement no paroxysms were documented by ambulatory or standard ECG, and pulsed-field ablation was deferred. Some months after he began wearing an Apple Watch Series 11 paired with an iPhone 15 Pro, he consulted the authors. He asked about notifications of nocturnal “respiratory disturbance”. He activated the watch ECG every morning and evening. AF paroxysms were detected repeatedly on mornings after nights the watch rated breathing disturbance “elevated”. They were not detected after “not elevated” nights, and they terminated by evening. He is undergoing CPAP therapy, and pulsed-field ablation will be considered depending on its effect on the paroxysms. No polysomnography was performed. The authors state that watch-detected breathing disturbance is not equivalent to the apnea-hypopnea index. They state that the watch ECG cannot fully substitute for conventional ECG, and that the notification algorithm “was reportedly developed using advanced machine learning”. The Food and Drug Administration (FDA) cleared Apple's Sleep Apnea Notification Feature under 510(k) K240929 on 13 September 2024. Apple's 510(k) submission says that it uses a deep learning algorithm on Apple Watch accelerometer data, analyzed in 30-day windows. It was trained on over 11,000 nights with polysomnography or home sleep-test reference. No treatment outcome is reported.", "benefit_type": "Improved Physical Health" } }, "provenance": { "kind": "source_review", "basis": "Updated only the mapped fields affected by this source review. Other mapped content and review decisions are preserved.", "record_fields": [ "account", "benefit_type" ], "source_refs": [ "AIBD-0300-source-0001", "AIBD-0300-source-0002" ], "reviewed_on": "2026-10-24" }, "review_state": "record_mapped", "coverage": "partial" }, "outcomes[].distribution": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial" }, "outcomes[].duration": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial" }, "outcomes[].id": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial" }, "outcomes[].stakeholder_group": { "state": "value_present", "value": { "kind": "record_fields", "fields": { "ratings": [ { "group": "personal", "depth": 1, "reason": "A man whose AF was thought quiescent learned that paroxysms recur after disturbed-breathing nights, and he started CPAP. No confirmed sleep-apnea diagnosis and no treatment effect are reported." } ] } }, "provenance": { "kind": "legacy_record", "basis": "Preserved from the existing AIBD record; external sources were not rechecked.", "record_fields": [ "ratings" ], "source_refs": [] }, "review_state": "record_mapped", "coverage": "partial" }, "outcomes[].status": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial" }, "outcomes[].tradeoffs": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial" }, "outcomes[].unexpected": { "state": "value_present", "value": { "kind": "record_fields", "fields": { "unexpected": false, "purpose": "The notification feature is built to identify patterns of breathing disturbance suggestive of moderate-to-severe sleep apnea and tell the user. The ECG app is built to record and classify single-lead rhythm. Both were used as designed." } }, "provenance": { "kind": "legacy_record", "basis": "Preserved from the existing AIBD record; external sources were not rechecked.", "record_fields": [ "unexpected", "purpose" ], "source_refs": [] }, "review_state": "record_mapped", "coverage": "partial" }, "places[]": { "state": "value_present", "value": { "kind": "record_fields", "fields": { "location": "Fukuoka, Japan", "developer_country": "United States" } }, "provenance": { "kind": "legacy_record", "basis": "Preserved from the existing AIBD record; external sources were not rechecked.", "record_fields": [ "location", "developer_country" ], "source_refs": [] }, "review_state": "record_mapped", "coverage": "partial" }, "purpose": { "state": "value_present", "value": { "kind": "record_fields", "fields": { "purpose": "The notification feature is built to identify patterns of breathing disturbance suggestive of moderate-to-severe sleep apnea and tell the user. The ECG app is built to record and classify single-lead rhythm. Both were used as designed." } }, "provenance": { "kind": "legacy_record", "basis": "Preserved from the existing AIBD record; external sources were not rechecked.", "record_fields": [ "purpose" ], "source_refs": [] }, "review_state": "record_mapped", "coverage": "partial" }, "record_dates": { "state": "value_present", "value": { "kind": "record_fields", "fields": { "date_observed": "2026-05-26", "date_basis": "source publication", "date_precision": "day", "revisions": [ { "date": "2026-10-20", "change": "Record drafted from the cited sources.", "editor": "AIBD" }, { "date": "2026-10-21", "change": "Benefit type set to Improved Physical Health under Trustible's full taxonomy of 23 types; it was Improved Accessibility among the six first used.", "source": "https://trustible.ai/post/a-framework-for-measuring-the-benefits-of-ai/", "editor": "AIBD" }, { "date": "2026-10-21", "change": "Added what the benefit is measured against from the cited sources.", "source": "https://pmc.ncbi.nlm.nih.gov/articles/PMC13301138/", "editor": "AIBD" }, { "date": "2026-10-21", "change": "Country of the developer added from the organization's own site or a registry.", "source": "https://en.wikipedia.org/wiki/Apple_Inc.", "editor": "AIBD" }, { "date": "2026-10-21", "change": "Prose pass: a rating reason, account, purpose, the replication conditions, the system's part rewritten in shorter sentences with abbreviations expanded; facts, figures and quotations unchanged.", "editor": "AIBD" }, { "date": "2026-10-24", "change": "Consolidated three excerpts of the clinical report and two excerpts of the 510(k) file into two sources. 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Followed the case's technical references to Apple's original white paper and submission. Corrected the prose to identify that the FDA-hosted technical summary was written by Apple. Preserved that CPAP began but no treatment outcome or polysomnographic confirmation was reported.", "source": "https://pmc.ncbi.nlm.nih.gov/articles/PMC13301138/", "editor": "AIBD" } ] } }, "provenance": { "kind": "source_review", "basis": "Updated only the mapped fields affected by this source review. 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Nightly breathing-disturbance ratings differ from the feature’s 30-day notification. Apple’s underlying training and validation records are not public.", "editor_note": "" } }, "sources[].citation_locator": { "state": "value_present", "value": { "kind": "record_fields", "fields": { "evidence": [ { "kind": "case report", "citation": "Maruyama T, Hieda M, Fukata M (2026). Smartwatch-Detected Atrial Fibrillation on the Morning After a Nocturnal Sleep-Disordered Breathing Notification: A Case Report. Cureus 18(5):e109701 (PMC13301138). Case Presentation, Figure 2, Discussion, and references 12–14.", "title": "Smartwatch-Detected Atrial Fibrillation on the Morning After a Nocturnal Sleep-Disordered Breathing Notification: A Case Report", "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC13301138/", "date": "2026-05-26", "written_by": "independent", "quote": "the smartwatch repeatedly detected AF paroxysms the following morning, only after the smartwatch had issued a breathing-disturbance notification during sleep." }, { "kind": "regulatory document", "citation": "Apple Inc. (2024). Sleep Apnea Notification Feature: 510(k) Summary, K240929, device description and performance testing, pp. 2 and 5–7, filed with the FDA. File includes FDA's September 13, 2024 substantial-equivalence letter.", "title": "510(k) Summary K240929: Sleep Apnea Notification Feature (SANF)", "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K240929.pdf", "date": "2024-09-13", "written_by": "makers", "quote": "SANF includes a deep learning algorithm to identify breathing disturbances using accelerometer sensor data from Apple Watch." } ] } }, "provenance": { "kind": "source_review", "basis": "Updated only the mapped fields affected by this source review. Other mapped content and review decisions are preserved.", "record_fields": [ "evidence" ], "source_refs": [ "AIBD-0300-source-0001", "AIBD-0300-source-0002" ], "reviewed_on": "2026-10-24" }, "review_state": "reviewed", "coverage": "partial" }, "sources[].id": { "state": "value_present", "value": { "kind": "identifiers", "identifiers": [ "AIBD-0300-source-0001", "AIBD-0300-source-0002" ], "role": "Retained evidence sources in reviewed order" }, "provenance": { "kind": "curatorial", "basis": "Updated identifiers after consolidating duplicate excerpts and reviewing original sources.", "record_fields": [ "evidence" ], "source_refs": [ "AIBD-0300-source-0001", "AIBD-0300-source-0002" ], "reviewed_on": "2026-10-24" }, "review_state": "reviewed", "coverage": "complete" }, "sources[].language": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial" }, "sources[].relationship": { "state": "value_present", "value": { "kind": "record_fields", "fields": { "evidence": [ { "kind": "case report", "citation": "Maruyama T, Hieda M, Fukata M (2026). Smartwatch-Detected Atrial Fibrillation on the Morning After a Nocturnal Sleep-Disordered Breathing Notification: A Case Report. Cureus 18(5):e109701 (PMC13301138). Case Presentation, Figure 2, Discussion, and references 12–14.", "title": "Smartwatch-Detected Atrial Fibrillation on the Morning After a Nocturnal Sleep-Disordered Breathing Notification: A Case Report", "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC13301138/", "date": "2026-05-26", "written_by": "independent", "quote": "the smartwatch repeatedly detected AF paroxysms the following morning, only after the smartwatch had issued a breathing-disturbance notification during sleep." }, { "kind": "regulatory document", "citation": "Apple Inc. (2024). Sleep Apnea Notification Feature: 510(k) Summary, K240929, device description and performance testing, pp. 2 and 5–7, filed with the FDA. File includes FDA's September 13, 2024 substantial-equivalence letter.", "title": "510(k) Summary K240929: Sleep Apnea Notification Feature (SANF)", "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K240929.pdf", "date": "2024-09-13", "written_by": "makers", "quote": "SANF includes a deep learning algorithm to identify breathing disturbances using accelerometer sensor data from Apple Watch." } ] } }, "provenance": { "kind": "source_review", "basis": "Updated only the mapped fields affected by this source review. Other mapped content and review decisions are preserved.", "record_fields": [ "evidence" ], "source_refs": [ "AIBD-0300-source-0001", "AIBD-0300-source-0002" ], "reviewed_on": "2026-10-24" }, "review_state": "reviewed", "coverage": "partial" }, "sources[].upstream_sources": { "state": "value_present", "value": { "kind": "structured", "data": { "reviewed_on": "2026-10-24", "lead_source_ref": "AIBD-0300-source-0001", "retained_source_order": [ "AIBD-0300-source-0001", "AIBD-0300-source-0002" ], "origins": [ { "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC13301138/", "contribution": "Original clinical narrative, ECGs and breathing-disturbance chart document consultation and management.", "locator": "Case Presentation; Figure 2; Discussion; references 12–14.", "relationship": "Treating clinical authors report the episode and declare no relevant support or financial relationships.", "source_refs": [ "AIBD-0300-source-0001" ] }, { "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K240929.pdf", "contribution": "Manufacturer specifies the deep-learning model, training and 30-day notification rule; FDA letter establishes clearance.", "locator": "FDA letter pp. 1–3; Apple summary pp. 2 and 5–7.", "relationship": "Mixed file: FDA's decision plus Apple's technical submission. The technical claims are maker-authored.", "source_refs": [ "AIBD-0300-source-0002" ] } ], "claim_chains": [ { "claim": "Patient episode and management", "path": [ "https://pmc.ncbi.nlm.nih.gov/articles/PMC13301138/", "Case Presentation and Figure 2" ], "finding": "The clinical authors interpreted the ECGs and chose CPAP. No CPAP response is reported, and no polysomnography confirmed sleep apnea." }, { "claim": "Machine learning and detection method", "path": [ "https://pmc.ncbi.nlm.nih.gov/articles/PMC13301138/", "References 12–14", "https://www.apple.com/health/pdf/sleep-apnea/Sleep_Apnea_Notifications_on_Apple_Watch_September_2024.pdf", "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K240929.pdf" ], "finding": "The original white paper and 510(k) summary describe Apple's own development and validation. The paper's references 12 and 13 resolve to the same Apple white paper, not two independent sources." }, { "claim": "Regulatory status", "path": [ "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K240929.pdf", "September 13, 2024 FDA substantial-equivalence letter" ], "finding": "Clearance concerns the product and intended use; it is not confirmation of this clinical outcome." } ], "limitations": [ "The article does not show whether the watch ECG classifier, rather than clinical reading, identified each AF episode.", "No polysomnography, controlled counterfactual, or treatment response is reported.", "Nightly breathing-disturbance categories and the feature's 30-day sleep-apnea notification are related but distinct outputs.", "Apple's underlying training and validation records were not publicly available for independent reproduction." ], "excluded_or_consolidated_sources": [ { "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC13301138/", "reason": "Duplicate excerpt of the retained clinical report or technical submission." }, { "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC13301138/", "reason": "Duplicate excerpt of the retained clinical report or technical submission." }, { "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K240929.pdf", "reason": "Duplicate excerpt of the retained clinical report or technical submission." } ], "review_scope": "Traced the claims in this case through accessible original publications and relevant embedded references, tables, appendices, corrections, and supplements. The stated access limits remain unresolved." } }, "provenance": { "kind": "source_review", "basis": "Read the available originals and relevant source chains, with unresolved access and evidentiary limits recorded explicitly.", "record_fields": [ "evidence" ], "source_refs": [ "AIBD-0300-source-0001", "AIBD-0300-source-0002" ], "reviewed_on": "2026-10-24" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "Treating clinicians report the consultation and ECG findings. Apple’s FDA submission describes the notification algorithm and its validation. FDA’s clearance is a regulatory decision, not confirmation of this patient’s benefit.", "editor_note": "" } }, "strategic_assessments[]": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial", "family": "strategic assessments" }, "summary": { "state": "value_present", "value": { "kind": "record_fields", "fields": { "summary": "Fukuoka case (Cureus, 26 May 2026): sleep-apnoea notifications prompted consultation; watch ECGs showed AF only after “elevated” breathing-disturbance nights; CPAP under way, no polysomnography.", "account": "Maruyama (Haradoi Hospital, Fukuoka), Hieda and Fukata reported a case in Cureus on 26 May 2026. The consultation is undated. The patient is a 79-year-old Japanese man with hypertension, dyslipidemia, type 2 diabetes and symptomatic paroxysmal atrial fibrillation (AF). A 12-lead electrocardiogram (ECG) had documented it a decade earlier. After retirement no paroxysms were documented by ambulatory or standard ECG, and pulsed-field ablation was deferred. Some months after he began wearing an Apple Watch Series 11 paired with an iPhone 15 Pro, he consulted the authors. He asked about notifications of nocturnal “respiratory disturbance”. He activated the watch ECG every morning and evening. AF paroxysms were detected repeatedly on mornings after nights the watch rated breathing disturbance “elevated”. They were not detected after “not elevated” nights, and they terminated by evening. He is undergoing CPAP therapy, and pulsed-field ablation will be considered depending on its effect on the paroxysms. No polysomnography was performed. The authors state that watch-detected breathing disturbance is not equivalent to the apnea-hypopnea index. They state that the watch ECG cannot fully substitute for conventional ECG, and that the notification algorithm “was reportedly developed using advanced machine learning”. The Food and Drug Administration (FDA) cleared Apple's Sleep Apnea Notification Feature under 510(k) K240929 on 13 September 2024. Apple's 510(k) submission says that it uses a deep learning algorithm on Apple Watch accelerometer data, analyzed in 30-day windows. It was trained on over 11,000 nights with polysomnography or home sleep-test reference. No treatment outcome is reported." } }, "provenance": { "kind": "source_review", "basis": "Updated only the mapped fields affected by this source review. Other mapped content and review decisions are preserved.", "record_fields": [ "summary", "account" ], "source_refs": [ "AIBD-0300-source-0001", "AIBD-0300-source-0002" ], "reviewed_on": "2026-10-24" }, "review_state": "reviewed", "coverage": "partial", "display": { "answer": "Apple Watch sleep-apnea notifications prompted a consultation. Clinicians found atrial fibrillation in morning ECG recordings after nights with elevated breathing disturbances and began CPAP treatment, without a confirmatory sleep study.", "editor_note": "" } }, "systems[].autonomy_permissions": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial" }, "systems[].component_role": { "state": "value_present", "value": { "kind": "text", "text": "The model detected elevated breathing disturbance and generated a notification." }, "provenance": { "kind": "legacy_record", "basis": "Restated the mechanical task already described in the existing system and AI-role fields. No new source review is claimed.", "record_fields": [ "system", "ai_role" ], "source_refs": [] }, "review_state": "record_mapped", "coverage": "partial" }, "systems[].deployment_configuration": { "state": "value_present", "value": { "kind": "text", "text": "The participant used an Apple Watch Series 11 with an iPhone 15 Pro." }, "provenance": { "kind": "legacy_record", "basis": "Separated the model, software, hardware, or operation already described in the existing record. No new source review is claimed.", "record_fields": [ "model_version", "system", "ai_role" ], "source_refs": [] }, "review_state": "record_mapped", "coverage": "partial" }, "systems[].inputs_outputs": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial" }, "systems[].model_name": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial" }, "systems[].model_version": { "state": "value_present", "value": { "kind": "record_fields", "fields": { "model_version": "Apple Watch Series 11 with iPhone 15 Pro" } }, "provenance": { "kind": "legacy_record", "basis": "Preserved from the existing AIBD record; external sources were not rechecked.", "record_fields": [ "model_version" ], "source_refs": [] }, "review_state": "record_mapped", "coverage": "partial", "display": { "answer": "Exact release not established.", "editor_note": "" } }, "systems[].product_name": { "state": "value_present", "value": { "kind": "record_fields", "fields": { "system": "Apple Watch Sleep Apnea Notification Feature (breathing-disturbance notifications) and the ECG app" } }, "provenance": { "kind": "legacy_record", "basis": "Preserved from the existing AIBD record; external sources were not rechecked.", "record_fields": [ "system" ], "source_refs": [] }, "review_state": "record_mapped", "coverage": "partial" }, "systems[].provider": { "state": "value_present", "value": { "kind": "structured", "data": { "application_developer": "Apple" } }, "provenance": { "kind": "legacy_record", "basis": "Mapped from the existing case description without a new external source review.", "record_fields": [ "developer" ], "source_refs": [] }, "review_state": "record_mapped", "coverage": "partial" }, "taxonomy_crosswalks[]": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial" }, "title": { "state": "value_present", "value": { "kind": "record_fields", "fields": { "title": "Apple Watch Series 11 breathing-disturbance notifications send a 79-year-old to his cardiologist; morning watch ECGs show AF after “elevated” nights and CPAP starts without polysomnography", "headline": "Apple Watch breathing alerts send a 79-year-old to CPAP therapy" } }, "provenance": { "kind": "legacy_record", "basis": "Preserved from the existing AIBD record; external sources were not rechecked.", "record_fields": [ "title", "headline" ], "source_refs": [] }, "review_state": "record_mapped", "coverage": "partial" }, "version": { "state": "value_present", "value": { "kind": "identifiers", "identifiers": [ "3c00ba05fd9e3361ace72306c00b7428276417fec489bdf1bb70cf22ba9853cd" ], "role": "SHA-256 of normalized original case data" }, "provenance": { "kind": "curatorial", "basis": "Updated the fingerprint after this targeted source review.", "record_fields": [], "source_refs": [], "reviewed_on": "2026-10-24" }, "review_state": "record_mapped", "coverage": "complete" }, "workflow": { "state": "value_present", "value": { "kind": "record_fields", "fields": { "account": "Maruyama (Haradoi Hospital, Fukuoka), Hieda and Fukata reported a case in Cureus on 26 May 2026. The consultation is undated. The patient is a 79-year-old Japanese man with hypertension, dyslipidemia, type 2 diabetes and symptomatic paroxysmal atrial fibrillation (AF). A 12-lead electrocardiogram (ECG) had documented it a decade earlier. After retirement no paroxysms were documented by ambulatory or standard ECG, and pulsed-field ablation was deferred. Some months after he began wearing an Apple Watch Series 11 paired with an iPhone 15 Pro, he consulted the authors. He asked about notifications of nocturnal “respiratory disturbance”. He activated the watch ECG every morning and evening. AF paroxysms were detected repeatedly on mornings after nights the watch rated breathing disturbance “elevated”. They were not detected after “not elevated” nights, and they terminated by evening. He is undergoing CPAP therapy, and pulsed-field ablation will be considered depending on its effect on the paroxysms. No polysomnography was performed. The authors state that watch-detected breathing disturbance is not equivalent to the apnea-hypopnea index. They state that the watch ECG cannot fully substitute for conventional ECG, and that the notification algorithm “was reportedly developed using advanced machine learning”. The Food and Drug Administration (FDA) cleared Apple's Sleep Apnea Notification Feature under 510(k) K240929 on 13 September 2024. Apple's 510(k) submission says that it uses a deep learning algorithm on Apple Watch accelerometer data, analyzed in 30-day windows. It was trained on over 11,000 nights with polysomnography or home sleep-test reference. No treatment outcome is reported.", "replication": { "produced_by": [ "Nightly watch wear with the sleep-apnea notification feature active, plus the owner's habit of recording a watch ECG every morning and evening", "A known history of paroxysmal AF that made the morning traces interpretable to his cardiologists", "Access to a clinic willing to act on watch data (CPAP started without polysomnography)" ], "must_hold": [ "The user completes onboarding and wears the watch during sleep, since the feature evaluates 30-day windows opportunistically", "Clinicians confirm with conventional ECG and polysomnography, which the authors say the watch cannot replace and which was not done here" ], "echoes": [] } } }, "provenance": { "kind": "source_review", "basis": "Updated only the mapped fields affected by this source review. Other mapped content and review decisions are preserved.", "record_fields": [ "account", "replication" ], "source_refs": [ "AIBD-0300-source-0001", "AIBD-0300-source-0002" ], "reviewed_on": "2026-10-24" }, "review_state": "record_mapped", "coverage": "partial" } }, "summary": { "total": 91, "addressed": 91, "known": 33, "reviewed": 11, "record_mapped": 22, "not_assessed": 58, "complete": false, "by_state": { "value_present": 33, "not_reported": 0, "unresolved": 0, "not_assessed": 58, "not_applicable": 0, "withheld": 0, "source_unavailable": 0 } } } }