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In one group the anesthesia team dosed fentanyl by the index, and in the other by blood pressure and heart rate. The SOLAR trial enrolled 50 patients at Leiden University Medical Center and Alrijne Hospital in 2019. The Abdomi-NOL trial enrolled 75 patients at Shaare Zedek Medical Center in Jerusalem from November 2019 to March 2021. FDA reviewers report that median pain scores in recovery fell by 1.6 points in SOLAR and by 1.5 points in Abdomi-NOL. They put these reductions at 30-33% on the 11-point scale. Fentanyl doses did not differ between groups. FDA granted the De Novo request on 17 February 2023. 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The index runs from 0 to 100 and tracks a patient's response to painful stimuli under general anesthesia. FDA reviewed two single-blinded randomized trials in major abdominal surgery under sevoflurane and fentanyl. In one group the anesthesia team dosed fentanyl by the index, and in the other by blood pressure and heart rate. The SOLAR trial enrolled 50 patients at Leiden University Medical Center and Alrijne Hospital in 2019. The Abdomi-NOL trial enrolled 75 patients at Shaare Zedek Medical Center in Jerusalem from November 2019 to March 2021. FDA reviewers report that median pain scores in recovery fell by 1.6 points in SOLAR and by 1.5 points in Abdomi-NOL. They put these reductions at 30-33% on the 11-point scale. Fentanyl doses did not differ between groups. FDA granted the De Novo request on 17 February 2023. Both trials were small, and neither took place in the United States."}},"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":"PMD-200 with the Nociception Level (NOL) index"}},"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 finds that dosing fentanyl by Medasense's NOL index left patients with less pain after abdominal surgery in two randomized trials","headline":"*PMD-200* guidance lowered pain scores after abdominal surgery"}},"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":["8668b222fe9f6538314f44005262e28e244d960f1bce26800c31caab4b5a87bd"],"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":"Medasense Biometrics of Ramat Gan, Israel, makes the PMD-200, a finger probe and monitor that combines several physiological signals into the Nociception Level (NOL) index. The index runs from 0 to 100 and tracks a patient's response to painful stimuli under general anesthesia. FDA reviewed two single-blinded randomized trials in major abdominal surgery under sevoflurane and fentanyl. In one group the anesthesia team dosed fentanyl by the index, and in the other by blood pressure and heart rate. The SOLAR trial enrolled 50 patients at Leiden University Medical Center and Alrijne Hospital in 2019. The Abdomi-NOL trial enrolled 75 patients at Shaare Zedek Medical Center in Jerusalem from November 2019 to March 2021. FDA reviewers report that median pain scores in recovery fell by 1.6 points in SOLAR and by 1.5 points in Abdomi-NOL. They put these reductions at 30-33% on the 11-point scale. Fentanyl doses did not differ between groups. FDA granted the De Novo request on 17 February 2023. Both trials were small, and neither took place in the United States.","replication":{"produced_by":["Investigators received instructions, set before enrollment, on how to dose fentanyl from the index.","Patients had major abdominal surgery under sevoflurane anesthesia with fentanyl boluses.","In the control group the device was connected but hidden from the anesthesia team."],"must_hold":["The patient is an adult under general anesthesia who receives opioid or opioid-sparing analgesia.","Clinicians read the index together with other clinical and vital signs."],"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":29,"reviewed":2,"reviewed_complete":2,"reviewed_partial":0,"record_mapped":27,"review_not_assessed":62,"not_assessed":0,"complete":false,"by_state":{"value_present":29,"not_reported":0,"unresolved":62,"not_assessed":0,"not_applicable":0,"withheld":0,"source_unavailable":0}}},"presentation_version":"5fcdddf3089caea475ea82c449f50572627e3f00f9dd86926622b5463e117a2c"}