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    K Number
    K242437
    Device Name
    Smile Dx®
    Manufacturer
    Cube Click, Inc.
    Date Cleared
    2025-05-14

    (271 days)

    Product Code
    MYN,LLZ
    Regulation Number
    892.2070
    Type
    Traditional
    Panel
    Radiology (RA)
    Reference & Predicate Devices
    K210365,K210187,K212519
    Why did this record match?
    Applicant Name (Manufacturer) :

    Cube Click, Inc.

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

    Smile Dx® is a computer-assisted detection (CADe) software designed to aid dentists in the review of digital files of bitewing and periapical radiographs of permanent teeth. It is intended to aid in the detection and segmentation of suspected dental findings which include: caries, periapical radiolucencies (PARL), restorations, and dental anatomy.

    Smile Dx® is also intended to aid dentists in the measurement (in millimeter and percentage measurements) of mesial and distal bone levels associated with each tooth.

    The device is not intended as a replacement for a complete dentist's review or their clinical judgment that takes into account other relevant information from the image, patient history, and actual in vivo clinical assessment.

    Smile Dx® supports both digital and phosphor sensors.

    Device Description

    Smile Dx® is a computer assisted detection (CADe) device indicated for use by licensed dentists as an aid in their assessment of bitewing and periapical radiographs of secondary dentition in adult patients. Smile Dx® utilizes machine learning to produce annotations for the following findings:

    • Caries
    • Periapical radiolucencies
    • Bone level measurements (mesial and distal)
    • Normal anatomy (enamel, dentin, pulp, and bone)
    • Restorations
    AI/ML Overview

    The provided FDA 510(k) Clearance Letter for Smile Dx® outlines the device's acceptance criteria and the studies conducted to prove it meets those criteria.

    Acceptance Criteria and Device Performance

    The acceptance criteria are implicitly defined by the performance metrics reported in the "Performance Testing" section. The device's performance is reported in terms of various metrics for both standalone and human-in-the-loop (MRMC) evaluations.

    Here's a table summarizing the reported device performance against the implied acceptance criteria:

    Table 1: Acceptance Criteria and Reported Device Performance

    Feature/MetricAcceptance Criteria (Implied)Reported Device Performance
    Standalone Testing:
    Caries DetectionHigh Dice, SensitivityDice: 0.74 [0.72 0.76]
    Sensitivity (overall): 88.3% [83.5%, 92.6%]
    Periapical Radiolucency (PARL) DetectionHigh Dice, SensitivityDice: 0.77 [0.74, 0.80]
    Sensitivity: 86.1% [80.2%, 91.9%]
    Bone Level Detection (Bitewing)High Sensitivity, Specificity, Low MAESensitivity: 95.5% [94.3%, 96.7%]
    Specificity: 94.0% [91.1%, 96.6%]
    MAE: 0.30 mm [0.29mm, 0.32mm]
    Bone Level Detection (Periapical)High Sensitivity, Specificity, Low MAE (percentage)Sensitivity: 87.3% [85.4%, 89.2%]
    Specificity: 92.1% [89.9%, 94.1%]
    MAE: 2.6% [2.4%, 2.8%]
    Normal Anatomy DetectionHigh Dice, Sensitivity, SpecificityDice: 0.84 [0.83, 0.85]
    Sensitivity (Pixel-level): 86.1% [85.4%, 86.8%]
    Sensitivity (Contour-level): 95.2% [94.5%, 96%]
    Specificity (Contour-level): 93.5% [91.6%, 95.8%]
    Restorations DetectionHigh Dice, Sensitivity, SpecificityDice: 0.87 [0.85, 0.90]
    Sensitivity (Pixel-level): 83.1% [80.3%, 86.4%]
    Sensitivity (Contour-level): 90.9% [88.2%, 93.9%]
    Specificity (Contour-level): 99.6% [99.3%, 99.8%]
    MRMC Clinical Evaluation - Reader Improvement:
    Caries Detection (wAFROC Δθ)Statistically significant improvement+0.127 [0.081, 0.172] (p
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