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510(k) Data Aggregation

    K Number
    K113618
    Device Name
    CLEARCORRECT SYSTEM
    Manufacturer
    CLEARCORRECT, INC.
    Date Cleared
    2012-03-19

    (103 days)

    Product Code
    NXC
    Regulation Number
    872.5470
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K082556,K093821
    Predicate For
    K151965,K163689,K171860,K172765,K173785,K180346,K180648,K182329,K191837,K192244,K192338,K210320,K210763,K212680,K223338
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ClearCorrect System is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). The ClearCorrect System positions teeth by way of continuous gentle force.

    Device Description

    The ClearCorrect device is fabricated of clear thin thermoformed polyeurathane plastic in a sequential series to progressively reposition the teeth. Corrective force to straighten the teeth is delivered via minor changes into a position in each subsequent aligner.

    AI/ML Overview

    The provided text describes the ClearCorrect System, an invisible braces system, and its substantial equivalence to predicate devices, rather than presenting a study with detailed acceptance criteria and performance data for a new device. Therefore, much of the requested information regarding specific acceptance criteria, sample sizes, expert involvement, and statistical outcomes is not explicitly available in the provided text.

    However, based on the information provided, here's a structured response addressing the requested points to the best of my ability, highlighting what is present and what is not:

    1. Table of Acceptance Criteria and Reported Device Performance

    The submission does not present a formal table of acceptance criteria with specific quantitative targets and corresponding device performance data. Instead, it relies on demonstrating substantial equivalence to predicate devices through comparisons of intended use, technological characteristics, and principles of operation, along with general non-clinical testing.

    Acceptance Criteria CategorySpecific Criteria (Implicit or Explicit from Text)Reported Device Performance (Summary from Text)
    Intended UseTreatment of tooth malocclusion in patients with permanent dentition."Comparable in the FS Aligner and the same in the unmodified ClearCorrect System."
    Mode of ActionAlignment of teeth by sequential use of preformed plastic trays."Comparable in the FS Aligner System and the same in the unmodified ClearCorrect System."
    MaterialThin thermoformed plastic material."Comparable over all three systems" (Predicate materials: Thermoformed polycarbonate, ClearCorrect Modified: Thermoformed polyeurathane).
    OTC or RxPrescription Use."Same" (Rx for all).
    BiocompatibilityUSP Class VI, ISO 10993-5 Cytotoxicity, ISO 10993-10 Intracutaneous Intradermal reactivity, Oral Mucosa Irritation test, Maximum test for Delayed Type Hypersensitivity."Found to be acceptable and supports the claims of substantial equivalence."
    Visual Performance(Not specified with criteria)Non-clinical testing performed. Results found acceptable.
    Mechanical Performance(Not specified with criteria)Non-clinical testing performed. Results found acceptable.
    Device Processing Performance(Not specified with criteria)Non-clinical testing performed. Results found acceptable.

    2. Sample Size Used for the Test Set and Data Provenance

    The text does not specify a sample size for a test set as it relies on non-clinical testing and substantial equivalence to predicate devices, rather than a de novo clinical or performance study with a dedicated test set. The data provenance is not mentioned, as detailed data from a specific study is not presented.

    3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

    This information is not applicable or available in the provided text. The submission focuses on demonstrating equivalence to existing devices and non-clinical testing, not on a study requiring expert-established ground truth for a test set.

    4. Adjudication Method for the Test Set

    This information is not applicable or available as there is no specific test set or clinical study described requiring adjudication.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

    No, an MRMC comparative effectiveness study is not mentioned in the provided text. The submission explicitly states, "There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device."

    6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

    The ClearCorrect System is a physical device (invisible braces) and not an algorithm. Therefore, the concept of "standalone (algorithm only)" performance is not applicable in this context.

    7. The Type of Ground Truth Used

    Given that no clinical study with explicit ground truth determination is described, this information is not applicable or available. The submission's "ground" for approval is substantial equivalence to predicate devices, supported by non-clinical performance and biocompatibility testing.

    8. The Sample Size for the Training Set

    This information is not applicable or available. The ClearCorrect System is a physical medical device, not a machine learning algorithm that requires a "training set" in the conventional sense.

    9. How the Ground Truth for the Training Set was Established

    This information is not applicable or available for the same reason as point 8.

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