CDM Insights

K240680

Oxford Brain Diagnostics Ltd · cleared 2024-12-06 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.4)
“CDM Insights is a post-processing image analysis software that assists trained healthcare practitioners in viewing, analyzing, and evaluating MR brain images of adults > 45 years of age.”
AlgorithmAutomated segmentation and quantitative analysis of individual brain structures and white matter hyperintensities; quantitative comparison of brain structures and derived values with normative data from a healthy population; presentation of results for reporting that includes numerical values as well as visualization of these results.
source quote (p.6)
“Automated segmentation and quantitative analysis of individual brain structures and white matter hyperintensities Quantitative comparison of brain structures and derived values with normative data from a healthy population Presentation of results for reporting that includes numerical values as well as visualization of these results”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.11)
“Cybersecurity documentation has been provided for CDM Insights in compliance with the FDA guidance document "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions." Medical device cybersecurity activities for CDM Insights were conducted to meet the requirements of multiple voluntary FDA Recognized Consensus Standards (i.e., AAMI TIR57 and ANSI AAMI SW96), as well as the FDA guidance documents "Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software,” “Postmarket Management of Cybersecurity in Medical Devices" and "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions."”

Validation studies (4)

Retrospective clinical

n=60 cases

endpoints: Dice overlap score; Visual ratings of segmentation quality; cortical surface quality

standards: ISO 13485, ISO 14971, IEC 62304, FDA guidance document "Design Control Guidance for Medical Manufacturers.", FDA guidance document "General Principles of Software Validation."

Retrospective clinical

n=121 patients

endpoints: Reproducibility

Retrospective clinical

n=1,500 patients

endpoints: Reproducibility

Retrospective clinical

n=2,000 scans · 13 site(s)

endpoints: Accuracy of percentiles

Reported performance (9 observations)

diceas written: “White matter hyperintensities Dice overlap score”0.66CI 0.15
source quote (p.11)
“White matter hyperintensities were automatically segmented with mean (standard deviation, SD) Dice overlap score of 0.66 (0.15), that exceeded the acceptance criterion of 0.58 taken from the primary predicate.”
diceas written: “Orbito-frontal Dice score”0.58CI 0.10
source quote (p.11)
“For eight representative cortical regions, the mean (SD) Dice scores were as follows: Orbito-frontal 0.58 (0.10)”
diceas written: “Superior-frontal Dice score”0.72CI 0.05
source quote (p.11)
“Superior-frontal 0.72 (0.05)”
diceas written: “Sensorimotor Dice score”0.69CI 0.14
source quote (p.11)
“Sensorimotor 0.69 (0.14)”
diceas written: “Ventral-temporal Dice score”0.58CI 0.05
source quote (p.11)
“Ventral-temporal 0.58 (0.05)”
diceas written: “Anterior-cingulate Dice score”0.6CI 0.09
source quote (p.11)
“Anterior-cingulate 0.60 (0.09)”
diceas written: “Precuneus Dice score”0.58CI 0.08
source quote (p.11)
“Precuneus 0.58 (0.08)”
diceas written: “Lateral-occipital Dice score”0.59CI 0.11
source quote (p.11)
“Lateral-occipital 0.59 (0.11)”
diceas written: “Medial-occipital Dice score”0.63CI 0.06
source quote (p.11)
“Medial-occipital 0.63 (0.06)”

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

0
recalls in product code, 24mo
3
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
0
drift signals on this device

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. 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).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K240680