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Patients scan their own eyes, and an AI module, the Notal OCT Analyzer, outlines fluid-like spaces and computes their volume for the physician. In the 001 Study at seven US sites, 180 adults were asked to image themselves daily for five weeks. Graders at a reading center compared home scans with clinic OCT scans taken within 24 hours. FDA reviewers report a positive percent agreement of 0.864 and a negative percent agreement of 0.849. The NPA's margin over 0.8 was not statistically significant. In a second study, the AI's outlines overlapped graders' outlines nearly as much as graders' outlines overlapped each other. FDA granted the De Novo request on 15 May 2024. FDA states that it has not been demonstrated whether the benefits will result in improved visual outcomes.","replication":{"produced_by":["Patients set up the device with an on-screen tutorial and imaged themselves every day for five weeks.","Remote technical support was available, and the reading center reviewed daily scans."],"must_hold":["The patient must have visual acuity of 20/320 or better and be able to calibrate the device.","Home scans must not replace or delay scheduled clinic visits."],"echoes":[]}}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["account","replication"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"}},"summary":{"total":91,"addressed":91,"known":27,"reviewed":2,"reviewed_complete":2,"reviewed_partial":0,"record_mapped":25,"review_not_assessed":64,"not_assessed":0,"complete":false,"by_state":{"value_present":27,"not_reported":0,"unresolved":64,"not_assessed":0,"not_applicable":0,"withheld":0,"source_unavailable":0}}},"presentation_version":"067c13f1adbabc7a1edde8def5ce7b3fe41fbc6e88bea3564285a0deef9884f9"}