ME-APDS™; MAGENTIQ-COLO™

K223473

Magentiq Eye LTD · cleared 2023-07-25 · product code QNP · Gastroenterology-Urology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.5)
“The ME-APDS (Magentiq Eye's Automatic Polyp Detection System) is intended to be used by endoscopists as an adjunct to the common video colonoscopy procedure (screening and surveillance), aiming to assist the endoscopist in identifying lesions during colonoscopy procedure by highlighting regions with visual characteristics consistent with different types of mucosal abnormalities that appear in the colonoscopy video during the procedure. The system acquires the digital video output signal from the local endoscopy camera and processes the video frames. It runs deep machine learning and additional supporting algorithms in real time on the video frames in order to detect and identify regions having characteristics consistent with different types of mucosal abnormalities such as polyps.”
Algorithmdeep machine learning, Deep Neural Networks (DNN) technology
source quote (p.5)
“It runs deep machine learning and additional supporting algorithms in real time on the video frames in order to detect and identify regions having characteristics consistent with different types of mucosal abnormalities such as polyps. Both systems' computing devices retrieve the video stream from the Endoscope and run a deep machine learning algorithms from the type of Deep Neural Networks (DNN) technology in real time.”
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedNo

Validation studies (3)

Bench

sample size not stated

endpoints: Pixel-level comparison of degradation of image quality; Software validation; EMC testing; Electrical safety testing

standards: IEC 60601-1-2:2014, IEC 60601-1:2005

Standalone

n=172 cases

endpoints: Polyp-wise Recall; Frame-wise Recall; False Positives Per Full Video (procedure) rate; False Positives Per Frame (FPPF)

Prospective clinical

n=950 patients · 10 site(s)

endpoints: APC: total number of adenomas detected and removed per examination; APE: the percentage of adenomas detected and removed divided by the total number of extractions (polypectomies or biopsies) during index colonoscopies

Reported performance (4 observations)

sensitivity99.6CI 100% to 99.6%
source quote (p.7)
“The system detects 100% to 99.6% (PRecall1 to PRecall7) of polyps verified by histology and 98.2% to 90% (PRecall1 to PRecall7) of the polyps when polyps without histology verification were included, showing the ability of the system to adequately aid in the detection of polyps when working with the ME-APDS.”
sensitivityas written: “Polyp-wise Recall (all polyps)”stated without valueCI 98.2% to 90%
source quote (p.7)
“The system detects 100% to 99.6% (PRecall1 to PRecall7) of polyps verified by histology and 98.2% to 90% (PRecall1 to PRecall7) of the polyps when polyps without histology verification were included, showing the ability of the system to adequately aid in the detection of polyps when working with the ME-APDS.”
time_to_resultas written: “Marker annotation latency median”0.166
source quote (p.7)
“The marker annotation latency's median, calculated over all the polyps, is 0.166 sec (5 frames)”
time_to_resultas written: “Marker annotation latency average”0.85
source quote (p.7)
“and its average is 0.85 sec.”

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
2
drift signals on this device
  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K252178 (decision 2025-10-03) from Magentiq Eye, Ltd. for a matching device line ("MAGENTIQ-COLO (ME-APDS)") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K252178

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K244023 (decision 2025-01-24) from Magentiq Eye LTD for a matching device line ("MAGENTIQ-COLO (ME-APDS)") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K244023

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/K223473