aprevo® Digital Segmentation
K231955Carlsmed, Inc. · cleared 2023-11-03 · product code QIH · Radiology
Premarket evidence — what FDA accepted
source quote (p.3)
“aprevo® Digital Segmentation software is intended to be used by trained, medically knowledgeable design personnel to perform digital image segmentation of the spine, primarily lumbar anatomy. The device inputs DICOM images and outputs a 3-D model of the spine.”
source quote (p.4)
“Upon removal of soft tissue and identification of spine structure, the software will utilize an AI-based algorithm to segment the structure and render a 3D model as an output.”
Validation studies (1)
Bench
sample size not stated
endpoints: IOU (intersection over union) score for segmentation; accuracy of vertebral body labeling; sensitivity; specificity
standards: FDA guidance document Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
Reported performance (4 observations)
source quote (p.6)
“with sensitivity and specificity exceeding 80% each.”
source quote (p.6)
“with sensitivity and specificity exceeding 80% each.”
source quote (p.6)
“The software performance was evaluated using an IOU (intersection over union) score for segmentation which exceeded the acceptance criteria of 80%.”
source quote (p.6)
“It was also evaluated for accuracy of vertebral body labeling which exceeded the acceptance criteria of 90% overall”
Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.
Predicate network
Postmarket — what happened after clearance
Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.
Reimbursement — how devices like this got paid
Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).