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A 5-point drop in re-operations was not statistically significant.","account":"Dune Medical Devices makes the MarginProbe System, a handheld probe that uses radiofrequency spectroscopy to measure the electrical properties of tissue removed in lumpectomy. A classification algorithm, tuned on tissue measurements matched to pathology, classifies each reading as positive or negative for cancer. From September 2008 to March 2010, 596 women with breast cancer were randomized after the main excision. Most were treated in Israel and the rest in the United States. In the device arm, surgeons probed the specimen and could shave more tissue. FDA reviewers report that complete re-excision of positive margins rose from 22.4% to 71.8%. They report that re-operations fell by 5 percentage points, from 25.8% to 20.8%, with p = 0.3177. The reviewers write that the contribution of the device was not assessed, because surgeons did not record why they took each extra shave. Device use also removed more tissue. FDA approved the system on 27 December 2012 and found that benefits outweigh risks for surgeons who do not routinely shave every cavity margin."}},"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":"MarginProbe System"}},"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 surgeons using the MarginProbe System removed more cancer at lumpectomy margins, with 5 percentage points fewer re-operations","headline":"*MarginProbe* helped surgeons remove cancer left at lumpectomy margins"}},"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":["5b430f41994971afd0e5c3382ed2e68896343b7831f21bc44303553c3ce8b044"],"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":"Dune Medical Devices makes the MarginProbe System, a handheld probe that uses radiofrequency spectroscopy to measure the electrical properties of tissue removed in lumpectomy. A classification algorithm, tuned on tissue measurements matched to pathology, classifies each reading as positive or negative for cancer. From September 2008 to March 2010, 596 women with breast cancer were randomized after the main excision. Most were treated in Israel and the rest in the United States. In the device arm, surgeons probed the specimen and could shave more tissue. FDA reviewers report that complete re-excision of positive margins rose from 22.4% to 71.8%. They report that re-operations fell by 5 percentage points, from 25.8% to 20.8%, with p = 0.3177. The reviewers write that the contribution of the device was not assessed, because surgeons did not record why they took each extra shave. Device use also removed more tissue. FDA approved the system on 27 December 2012 and found that benefits outweigh risks for surgeons who do not routinely shave every cavity margin.","replication":{"produced_by":["Surgeons probed the margins of the main specimen right after excision.","Surgeons completed a training phase before they randomized patients."],"must_hold":["The patient has previously diagnosed breast cancer and undergoes lumpectomy.","The surgeon does not routinely shave every cavity margin in the same operation."],"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":28,"reviewed":2,"reviewed_complete":2,"reviewed_partial":0,"record_mapped":26,"review_not_assessed":63,"not_assessed":0,"complete":false,"by_state":{"value_present":28,"not_reported":0,"unresolved":63,"not_assessed":0,"not_applicable":0,"withheld":0,"source_unavailable":0}}},"presentation_version":"7d5c4107ae726145c46d366afdac10799a0b713207f08de6b41ab4047fa18ee6"}