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510(k) Data Aggregation

    K Number
    K213686
    Device Name
    SKOUT Software
    Manufacturer
    Iterative Scopes Inc.
    Date Cleared
    2022-08-12

    (263 days)

    Product Code
    QNP
    Regulation Number
    876.1520
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SKOUT Software

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The SKOUT system is a software device designed to detect potential colorectal polyps in real time during colonoscopy examinations. It is indicated as a computer-aided detection tool providing colorectal polyps location information to assist qualified and trained gastroenterologists in identifying potential colorectal polyps during colonoscopy examinations in adult patients undergoing colorectal cancer screening or surveillance.

    The SKOUT system is only intended to assist the gastroenterologist in identifying suspected colorectal polyps and the gastroenterologist is responsible for reviewing SKOUT suspected polyp areas and confirming the presence of a polyp based on their own medical judgment. SKOUT is not intended to replace a full patient evaluation, nor is it intended to be relied upon to make a primary interpretation of endoscopic procedures, medical diagnosis, or recommendations of treatment/course of action for patients. SKOUT is indicated for white light colonoscopy only.

    Device Description

    The SKOUT™ system is a software-based computer aided detection (CADe) system for the analysis of high-definition endoscopic video during colonoscopy procedures. The SKOUT™ system is intended to aid gastroenterologists with the detection of potential colorectal polyps during colonoscopy by providing an informational visual aid on the endoscopic monitor using trained software that processes the endoscopic video in real time.

    Users will primarily interact with the SKOUT™ system by observing the software display, including the polyp detection box and device status indicator signal.

    AI/ML Overview

    Acceptance Criteria and Device Performance for SKOUT™ System

    1. Table of Acceptance Criteria and Reported Device Performance

    The provided document doesn't explicitly state "acceptance criteria" in a separate section. However, it presents the results of "Non-clinical performance testing" and "Clinical Testing" with specific metrics and confidence intervals, which serve as the performance benchmarks the device has met.

    Based on the information provided, here's a table summarizing the implicit acceptance criteria (as demonstrated by the positive study outcomes) and the reported device performance:

    Acceptance Criterion (Implicit)Reported Device PerformanceStudy Type
    Non-Clinical Performance:
    Object Level True Positive Rate (TPR): High proportion of actual polyps detected by the device.97.87% (95% CI: 94.96%, 100.0%)Standalone Algorithm Performance Testing
    Object Level False Positives (FP): Low number of non-polyps flagged as polyps per procedure.22.55 objects per 15-minute interval (95% CI: 18.954, 26.148)Standalone Algorithm Performance Testing
    Frame Level True Positive Rate (TPR): High proportion of frames with confirmed polyps where the device bounds the polyp.Mean: 55.66% (95% CI: 55.50%, 55.83%)Standalone Algorithm Performance Testing
    Frame Level False Positive Rate (FPR): Low proportion of frames where the device bounds an object not detected by the gastroenterologist.Mean: 2.31% (95% CI: 2.16%–2.44%)Standalone Algorithm Performance Testing
    Marker Overlap (IOGT): High proportion of ground truth polyp area engulfed by the SKOUT bounding box to ensure appropriate visibility for the physician. (Implied acceptance of IOGT = 1.0 as a positive indicator given the purpose of bounding box enlargement).Median IOGT of signal: 1.0 (meaning on a median basis, all polyps were engulfed by a SKOUT bounding box). Mean IOU: 0.299 (95% CI: 0.289, 0.309) which is expected to be low due to artificial bounding box enlargement.Standalone Algorithm Performance Testing
    Image Quality Degradation: No visually detectable degradation due to the device.No visually detectable differences between images found with the introduction of the SKOUT™ system.Special Control Testing
    Video Delay due to Marker Annotation: Minimal delay introduced by the device.SDI: 56.00ms (95% CI: 50.54, 61.46) and 3.25 frame delay (95% CI: 2.93, 3.56). DVI: 62.33ms (95% CI: 60.76, 63.90) and 3.74 frame delay (95% CI: 3.65, 3.83).Special Control Testing
    Real-time Endoscopic Video Delay: Minimal delay in real-time video feed.SDI: 56.67ms (95% CI: 51.01, 62.33) and 3.28 frame delay (95% CI: 2.96, 3.62). DVI: 60.67ms (95% CI: 57.72, 63.61) and 3.64 frame delay (95% CI: 3.46, 3.81).Special Control Testing
    Clinical Performance:
    Adenomas Per Colonoscopy (APC): Significant improvement in the number of adenomas detected per colonoscopy with AI assistance.Treatment (AI-aided arm): 1.054 Control (Standard colonoscopy): 0.830 Difference (Treatment - Control): 0.224 (95% CI: 0.060, 0.382), p-value: 0.002 (Statistically significant increase)Multi-center, prospective, randomized controlled trial (Clinical Study)
    Positive Percent Agreement (PPA) / Positive Predictive Value (PPV): Non-inferiority or comparable safety profile to standard colonoscopy. (PPA/PPV used as a safety endpoint representing the fraction of resected lesions that were indeed polyps).PPA (mITT cohort): Control: 75.7% Treatment: 70.9% Difference: -4.8% (95% CI: -9.5% to 0.3%) and p-value: **
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