CADDIE

K252586

Odin Medical Limited · cleared 2025-09-12 · product code QNP · Gastroenterology-Urology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.6)
“CADDIE is cloud based artificial intelligence medical device software.”
Algorithmartificial intelligence and deep learning algorithms
source quote (p.10)
“For cecal detection, there are changes in adopted algorithm models, however, both devices use artificial intelligence and deep learning algorithms in analyzing frozen images taken.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (1)

Bench

n=5,733 images

endpoints: Frame-level accuracy; Frame-level TPR; Frame-level FPR

Reported performance (7 observations)

sensitivity0.8914CI [89.06, 89.22]
source quote (p.11)
“Frame-level TPR Overall 89.14% [89.06, 89.22]”
specificity0.9082
source quote (p.11)
“Frame-level FPR Overall 9.18% [9.13, 9.24]”
aurocas written: “auc”0.9359CI [93.55, 93.62]
source quote (p.12)
“AUC: 93.59 [93.55, 93.62]”
accuracyas written: “Frame-level accuracy”0.9038CI [90.34, 90.43]
source quote (p.11)
“Frame-level accuracy Overall 90.38% [90.34, 90.43]”
sensitivityas written: “Frame-level TPR (Appendiceal Orifice (AO))”0.8339CI [83.27, 83.51]
source quote (p.11)
“Appendiceal Orifice (AO) 83.39% [83.27, 83.51]”
accuracyas written: “Frame-level accuracy (Ileocecal Valve (ICV))”0.9432CI [94.29, 94.36]
source quote (p.11)
“Ileocecal Valve (ICV) 94.32% [94.29, 94.36]”
sensitivityas written: “Frame-level TPR (Ileocecal Valve (ICV))”0.8378CI [83.66, 83.91]
source quote (p.11)
“Ileocecal Valve (ICV) 83.78% [83.66, 83.91]”

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
0
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 Gastroenterology-Urology 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/K252586