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Some tested their own semen, and others tested samples from other participants. A point-of-care professional then tested the same samples on the LensHooke and on the SQA-V reference analyzer. For sperm concentration, lay users' results against the reference had a slope of 0.98 and an R2 of 0.98. Motility had a slope of 0.98 and an R2 of 0.95, and morphology a slope of 0.78 and an R2 of 0.73. FDA cleared the devices on 16 November 2018. The study ran at evaluation sites, one of them internal, and not in users' homes. 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Their sperm concentration results tracked a reference analyzer with a slope of 0.98 and an R2 of 0.98.","account":"Bonraybio of Taiwan makes the LensHooke X1 Semen Quality Analyzer for home use and the X1 PRO for clinics. According to FDA reviewers, the devices combine optical design and image analysis with an artificial intelligence image processing method. They measure sperm concentration, motility and morphology and the pH of semen. In a user performance study at three evaluation sites, 100 lay users aged 21 to 60 followed only the package insert. Some tested their own semen, and others tested samples from other participants. A point-of-care professional then tested the same samples on the LensHooke and on the SQA-V reference analyzer. For sperm concentration, lay users' results against the reference had a slope of 0.98 and an R2 of 0.98. Motility had a slope of 0.98 and an R2 of 0.95, and morphology a slope of 0.78 and an R2 of 0.73. FDA cleared the devices on 16 November 2018. The study ran at evaluation sites, one of them internal, and not in users' homes. The summary does not say whether the image processing learned from data."}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["summary","account"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"systems[].autonomy_permissions":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"systems[].component_role":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"systems[].deployment_configuration":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"systems[].inputs_outputs":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"systems[].model_name":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"systems[].model_version":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"systems[].product_name":{"state":"value_present","value":{"kind":"record_fields","fields":{"system":"LensHooke X1 and X1 PRO Semen Quality Analyzer"}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["system"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"systems[].provider":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"taxonomy_crosswalks[]":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"title":{"state":"value_present","value":{"kind":"record_fields","fields":{"title":"FDA found that 100 lay users of Bonraybio's LensHooke X1 semen analyzer got sperm concentration results that closely matched a reference analyzer","headline":"*LensHooke X1* let lay users measure sperm concentration accurately"}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["title","headline"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"version":{"state":"value_present","value":{"kind":"identifiers","identifiers":["2ba064791857fca55588b79a647d198a11bac806717bb3878d32ced43b23018b"],"role":"SHA-256 of the complete public record and its assessments"},"provenance":{"kind":"curatorial","basis":"SHA-256 of the public record, its assessments, and its displayed answers and notes, excluding its own identifier and the derived coverage summary.","record_fields":[],"source_refs":[]},"review_state":"record_mapped","coverage":"complete"},"workflow":{"state":"value_present","value":{"kind":"record_fields","fields":{"account":"Bonraybio of Taiwan makes the LensHooke X1 Semen Quality Analyzer for home use and the X1 PRO for clinics. According to FDA reviewers, the devices combine optical design and image analysis with an artificial intelligence image processing method. They measure sperm concentration, motility and morphology and the pH of semen. In a user performance study at three evaluation sites, 100 lay users aged 21 to 60 followed only the package insert. Some tested their own semen, and others tested samples from other participants. A point-of-care professional then tested the same samples on the LensHooke and on the SQA-V reference analyzer. For sperm concentration, lay users' results against the reference had a slope of 0.98 and an R2 of 0.98. Motility had a slope of 0.98 and an R2 of 0.95, and morphology a slope of 0.78 and an R2 of 0.73. FDA cleared the devices on 16 November 2018. The study ran at evaluation sites, one of them internal, and not in users' homes. The summary does not say whether the image processing learned from data.","replication":{"produced_by":["Lay users followed only the instructions in the package insert.","Samples were collected in the kit's cup and left to liquefy for at least 30 minutes before testing."],"must_hold":["The test is run within one hour of collecting the sample.","The home device is used by one person and is not shared."],"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":"74b5de3a00baad3750f01a39a3b8ceb469f6204af9671c783d484126d2252ec4"}