SKOUT Software

K213686

Iterative Scopes Inc. · cleared 2022-08-12 · product code QNP · Gastroenterology-Urology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.4)
“The SKOUT™™ system is a software-based computer aided detection (CADe) system for the analysis of high-definition endoscopic video during colonoscopy procedures.”
Algorithmartificial intelligence-based algorithm
source quote (p.6)
“The SKOUT™™ system 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 (2)

Standalone

n=79 images

endpoints: Object Level TPR: The proportion of suspected polyps that were detected by the device in the evaluation dataset and confirmed to be polyps using pathology findings.; Object Level FPs: The number of suspected polyps that the device bounds per procedure which are not confirmed to be polyps by a) resection and b) pathology findings.; Frame Level TPR: The proportion of all the frames with confirmed polyps in which the device bounds the polyp in the evaluation dataset.; Frame Level FPR: The proportion of frames in which the device bounds an object that is not detected by the gastroenterologist in a colonoscopy during normal use (does not include frames when a surgical tool or NBI is detected).

Prospective clinical

n=1,359 patients · 5 site(s)

endpoints: APC: The total number of adenomas detected divided by the total number of colonoscopies.; PPA**: PPA is the fraction of adenomas, sessile serrated lesions, and hyperplastic polyps of the proximal colon (caecum, ascending colon, hepatic flexure, and transverse colon) out of the total number of resections.; PPA (or PPV): It is the fraction of adenomas, sessile serrated lesions, and large (>10mm) hyperplastic polyps of the proximal colon (caecum, ascending colon, hepatic flexure, and transverse colon) out of total number of resections.

Reported performance (4 observations)

sensitivity97.87CI 95% CI: 94.96, 100.0
source quote (p.9)
“Object Level True Positive Rate (TPR) 97.87 (95% CI: 94.96, 100.0)”
sensitivityas written: “True positive rate per frame”55.66CI 95% CI: 55.50, 55.83
source quote (p.9)
“True positive rate per frame Mean: 55.66 % (95% CI: 55.50, 55.83)”
ppvas written: “Positive Predictive Value (Difference)”-0.043CI (-0.094, 0.010)
source quote (p.16)
“Positive Predictive Value 0.717 0.674 -0.043 (-0.094, 0.010) <0.001”
detection_rateas written: “Adenoma Detection Rate (Difference)”0.039CI (-0.012, 0.097)
source quote (p.16)
“Adenoma Detection Rate* 0.439 0.478 0.039 (-0.012, 0.097) 0.065”

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
3
drift signals on this device
  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K241508 (decision 2024-07-03) from Iterative Scopes, Inc. for a matching device line ("SKOUT® system") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K241508

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K240781 (decision 2024-04-19) from Iterative Scopes, Inc. for a matching device line ("SKOUT® system") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K240781

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K230658 (decision 2023-04-07) from Iterative Scopes Inc. for a matching device line ("SKOUT® system") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K230658

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/K213686