CADDIE

K240044

Odin Medical Limited · cleared 2024-07-24 · product code QNP · Gastroenterology-Urology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.4)
“CADDIE is cloud based artificial intelligence medical device software.”
Algorithmartificial intelligence-based algorithm
source quote (p.7)
“CADDIE utilizes an artificial intelligence-based algorithm to perform the polyp detection function.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (3)

Bench

n=389 patients

endpoints: Object-level true positive rate (TPR); Frame-Level FPR; Frame-level TPR; Object-level TPR; Object-level FPR

Bench

n=5,092 cases

endpoints: Frame-Level true positive rate (TPR); Frame-level false positive rate (FPR); Frame-level accuracy

Prospective clinical

n=841 patients · 8 site(s)

endpoints: Adenomas per colonoscopy (APC); Positive percent agreement (PPA); Adenoma Detection Rate (ADR); Sessile serrated adenomas per colonoscopy (SSAPC); Sessile serrated adenomas per colonoscopy (SSAPC*); Neoplastic Polyps Per Colonoscopy (NPPC); Polyps Per Colonoscopy (PPC); Colonoscope withdrawal time of negative procedures only; Colonoscope withdrawal time; Total procedure time

Reported performance (3 observations)

sensitivity0.9827CI [97.33, 99.20]
source quote (p.13)
“Object-level TPR > 80% (to show a lower miss rate than in clinical practice of 25%[1]) 98.27% [97.33, 99.20]”
aurocas written: “auc”0.79609CI [0.79600, 0.79619]
source quote (p.15)
“AUC: 0.79609 CI 95%: [0.79600, 0.79619]”
sensitivityas written: “Frame-Level TPR”0.5492CI [53.02, 56.81]
source quote (p.14)
“Frame-Level TPR** The proportion of frames (%) with confirmed polyps in which CADDIE detects the polyp (> 0.5 seconds & IoU > 20%). Not applicable 54.92 [53.02, 56.81]”

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
1
drift signals on this device
  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K252586 (decision 2025-09-12) from Odin Medical Limited for a matching device line ("CADDIE") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K252586

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/K240044